Editor’s note: Find more information about long COVID in Medscape’s Long COVID Resource Center.

Sept. 22, 2022 – Entrepreneur Maya McNulty, 49, was one of the first victims of the COVID-19 pandemic. The Schenectady, NY, businesswoman spent 2 months in the hospital after catching the disease in March 2020. That September, she was diagnosed with long COVID.

“Even a simple task such as unloading the dishwasher became a major challenge,” she says.

Over the next several months, McNulty saw a range of specialists, including neurologists, pulmonologists, and cardiologists. She had months of physical therapy and respiratory therapy to help regain strength and lung function. While many of the doctors she saw were sympathetic to what she was going through, not all were.

“I saw one neurologist who told me to my face that she didn’t believe in long COVID,” she recalls. “It was particularly astonishing since the hospital they were affiliated with had a long COVID clinic.”

McNulty began to connect with other patients with long COVID through a support group she created at the end of 2020 on the social media app Clubhouse. They exchanged ideas and stories about what had helped one another, which led her to try, over the next year, a plant-based diet, Chinese medicine, and vitamin C supplements, among other treatments.

She also acted on unscientific reports she found online and did her own research, which led her to discover claims that some asthma patients with chronic coughing responded well to halotherapy, or dry salt therapy, during which patients inhale micro-particles of salt into their lungs to reduce inflammation, widen airways, and thin mucus. She’s been doing this procedure at a clinic near her home for over a year and credits it with helping with her chronic cough, especially as she recovers from her second bout of COVID-19.

It’s not cheap – a single half-hour session can cost up to $50 and isn’t covered by insurance. There’s also no good research to suggest that it can help with long COVID, according to the Cleveland Clinic.

McNulty understands that but says many people who live with long COVID turn to these treatments out of a sense of desperation.

“When it comes to this condition, we kind of have to be our own advocates. People are so desperate and feel so gaslit by doctors who don’t believe in their symptoms that they play Russian roulette with their body,” she says. “Most just want some hope and a way to relieve pain.”

Across the country, 16 million Americans have long COVID, according to the Brookings Institution’s analysis of a 2022 Census Bureau report. The report also estimated that up to a quarter of them have such debilitating symptoms that they are no longer able to work. While long COVID centers may offer therapies to help relieve symptoms, “there are no evidence-based established treatments for long COVID at this point,” says Andrew Schamess, MD, a professor of internal medicine at Ohio State Wexner Medical Center, who runs its Post-COVID Recovery Program. “You can’t blame patients for looking for alternative remedies to help them. Unfortunately, there are also a lot of people out to make a buck who are selling unproven and disproven therapies.”

Sniffing Out the Snake Oil

With few evidence-based treatments for long COVID, patients with debilitating symptoms can be tempted by unproven options. One that has gotten a lot of attention is hyperbaric oxygen. This therapy has traditionally been used to treat divers who have decompression sickness, or the bends. It’s also being touted by some clinics as an effective treatment for long COVID.

A very small trial of 73 patients with long COVID, published this July in the journal Scientific Reports, found that those treated in a high-pressure oxygen system 5 days a week for 2 months showed improvements in brain fog, pain, energy, sleep, anxiety, and depression, compared with similar patients who got sham treatments. But larger studies are needed to show how well it works, notes Schamess.

“It’s very expensive – roughly $120 per session – and there just isn’t the evidence there to support its use,” he says.

In addition, the therapy itself carries risks, such as ear and sinus pain, middle ear injury, temporary vision changes, and, very rarely, lung collapse, according to the FDA.

One “particularly troubling” treatment being offered, says Kathleen Bell, MD, chair of the Department of Physical Medicine and Rehabilitation at the University of Texas Southwestern Medical Center, is stem cell therapy. This therapy is still in its infancy, but it’s being marketed by some clinics as a way to prevent COVID-19 and also treat long-haul symptoms.

The FDA has issued advisories that there are no products approved to treat long COVID and recommends against their use, except in a clinical trial.

“There’s absolutely no regulation – you don’t know what you’re getting, and there’s no research to suggest this therapy even works,” says Bell. It’s also prohibitively expensive – one Cayman Islands-based company advertises its treatment for as much as $25,000.

Patients with long COVID are even traveling as far as Cyprus, Germany, and Switzerland for a procedure known as blood washing, in which large needles are inserted into veins to filter blood and remove lipids and inflammatory proteins, the British Medical Journal reported in July. Some patients are also prescribed blood thinners to remove microscopic blood clots that may contribute to long COVID. But this treatment is also expensive, with many people paying $10,000-$15,000 out of pocket, and there’s no published evidence to suggest it works, according to theBMJ.

It can be particularly hard to discern what may work and what’s unproven, since many primary care providers are themselves unfamiliar with even traditional long COVID treatments, Bell says. She recommends that patients ask the following questions:

  • What published research is there to support these claims?
  • How long should I expect to do this treatment before I see an improvement?
  • What are the potential side effects?
  • Will the medical provider recommending the treatment work with your current medical team to monitor progress?

“If you can’t get answers to these questions, take a step back,” says Bell.

Sorting Through Supplements

Yufang Lin, MD, an integrative specialist at the Cleveland Clinic, says many patients with long COVID enter her office with bags of supplements.

“There’s no data on them, and in large quantities, they may even be harmful,” she says.

Instead, she works closely with the Cleveland Clinic’s long COVID center to do a thorough workup of each patient, which often includes screening for certain nutritional deficiencies.

“Anecdotally, we do see many patients with long COVID who are deficient in these vitamins and minerals,” says Lin. “If someone is low, we will suggest the appropriate supplement. Otherwise, we work with them to institute some dietary changes.”

­This usually involves a plant-based, anti-inflammatory eating pattern such as the Mediterranean diet, which is rich in fruits, vegetables, whole grains, nuts, fatty fish, and healthy fats such as olive oil and avocados.

Other supplements some doctors recommend for patients with long COVID are meant to treat inflammation, Bell says, although there’s not good evidence they work. One is the antioxidant coenzyme Q10.

But a small preprint study published in The Lancet this past August of 121 patients with long COVID who took 500 milligrams a day of coenzyme Q10 for 6 weeks saw no differences in recovery than those who took a placebo. Because the study is still a preprint, it has not been peer-reviewed.

Another is probiotics. A small 2021 study published in the journal Infectious Diseases Diagnosis & Treatment found that a blend of five lactobacillus probiotics, along with a prebiotic called inulin, taken for 30 days, helped with long-term COVID symptoms such as coughing and fatigue. But larger studies need to be done to support their use.

One that may have more promise is omega-3 fatty acids. Like many other supplements, these may help with long COVID by easing inflammation, says Steven Flanagan, MD, a rehabilitation medicine specialist at NYU Langone in New York who works with long COVID patients. Researchers at the Mount Sinai School of Medicine in New York are studying whether a supplement can help patients who have lost their sense of taste or smell after an infection, but results aren’t yet available.

Among the few alternatives that have been shown to help patients are mindfulness-based therapies – in particular, mindfulness-based forms of exercise such as tai chi and qi gong may be helpful, as they combine a gentle workout with stress reduction.

“Both incorporate meditation, which helps not only to relieve some of the anxiety associated with long COVID but allows patients to redirect their thought process so that they can cope with symptoms better,” says Flanagan.

A 2022 study published in BMJ Open found that these two activities reduced inflammatory markers and improved respiratory muscle strength and function in patients recovering from COVID-19.

“I recommend these activities to all my long COVID patients, as it’s inexpensive and easy to find classes to do either at home or in their community,” he says. “Even if it doesn’t improve their long COVID symptoms, it has other benefits such as increased strength and flexibility that can boost their overall health.”

Source link

The Art of Living Foundation Presents SKY Meditation To Reduce PTSD Among Veterans

Non-profit educational and humanitarian organization, The Art of Living Foundation, introduces SKY Meditation as an open window to reduce PTSD among veterans through a recent study

The team at The Art of Living Foundation is staying true to the philosophy of promoting a stress-free mind and a violence-free society as preached by the founder of the organization and spiritual teacher, Sri Sri Ravi Shankar, with the nonprofit announcing the introduction of SKY Meditation to veterans. The Art of Living Foundation has grown to become the go-to resource for stress management and wellness, attracting people from all walks of life backgrounds and religious orientations.

PTSD is widespread among our Veterans. And yet, our first-line treatment–cognitive processing therapy– works only 60% of the time. This is why offering alternative and complimentary therapies for Veterans is so vital. I am pleased to report that in our Randomized Clinical Trial, we found Sky Breathing Meditation (SKY) to be non-inferior to CPT for treatment of symptoms of PTSD. These results open the door for our Vets to gain access to treatments such as SKY which may be more cost-effective, preferable, and more effective for some.”


Video Link: player.vimeo.com/video/739167412

The introduction of SKY Meditation to veterans is timely, considering the widespread of PTSD. The Art of Living Foundation conducted a study recently, publishing a paper in BMJ Open titled Randomised clinical non-inferiority trial of breathing-based meditation and cognitive processing therapy for symptoms of post-traumatic stress disorder in military veterans. SKY Meditation was developed by Gurudev Sri Sri Ravi Shankar, blending ancient Vedic wisdom with a modern sensibility for a new paradigm of leadership and living – a stress-free, violence-free society. Over the years, research has shown the immense mental health and overall well-being benefits of the technique, helping to reduce stress, anxiety, depression, and trauma. Consequently, the introduction of SKY Meditation to veterans will undoubtedly help create a safer, better society.

To see Project Welcome Home Troops or introduce a Veteran who would like to learn SKY- Sky Breath Meditation, visit – https://www.artofliving.org/. The campaign for a better world continues across social media, including Twitter and YouTube.

About The Art of Living

The Art of Living was founded in 1981 by the world-renowned humanitarian and spiritual teacher, Sri Sri Ravi Shankar. Operating in over 150 countries, the non-profit aims to create a stress-free, violence-free society through several initiatives as well as educational and self-development programs and tools.

Media Contact
Company Name: The Art of Living Foundation
Contact Person: Carlos Anaya
Email: Send Email
Phone: 917-204-8917
Address: 2401 15th St. NW
City: Washington, DC 20009
Country: United States
Website: www.artofliving.org/



Source link

Hantavirus is a disease caused by one of several types of hantaviruses. Hantaviruses can cause a range of flu-like symptoms that progress over days and weeks. In the later stages of the disease, hantavirus can cause difficulty breathing as fluid builds up in your lungs.

Wild rodents, including mice and rats, can carry hantaviruses. People are most commonly exposed to hantaviruses when they come into contact with rodents and their urine, droppings, or saliva. This can be through food, contaminated air, or, rarely, a rodent bite.

In the United States, most people with hantavirus live west of the Mississippi River, though there have been reports of some people with it to the east of the river.

In North and South America, some hantaviruses can progress into a rare but severe lung disease called hantavirus pulmonary syndrome (HPS). HPS may begin with mild flu-like symptoms but can rapidly progress in a few days.

In other parts of the world, several strains of hantavirus are known to cause hemorrhagic fever with renal syndrome (HFRS).

This article will review the effects of HPS and HFRS, how doctors or other healthcare professionals manage these conditions, and what you can do to protect yourself against hantavirus infections.

Hantavirus is mainly an airborne virus. That means you come in contact from breathing in air that the virus has contaminated. The virus gets into the air when forces, such as the elements or other animal or human activity, stir up rodent urine, droppings, or nests.

But experts believe you can also contract the virus in other ways, including:

  • touching a contaminated object and then touching your nose or mouth
  • eating contaminated food
  • rodent bites, although rare

A person with a hantavirus infection, including those that may cause HPS and HFRS, may develop symptoms anywhere between 1 to 3 weeks after exposure.

Symptoms often begin as mild and progress over a matter of days and weeks. As the disease progresses, the defining signs are:

The two most common diseases associated with hantavirus infections are HPS and HFRS. Let’s take a look at their symptoms.

Hantavirus pulmonary syndrome (HPS)

While many people experience a mild hantavirus infection, some hantavirus infections progress into HPS. HPS can eventually lead to fluid buildup, causing severe lung issues.

At first, a person with HPS may experience flu-like symptoms such as:

  • fever
  • fatigue
  • muscle aches
  • headache
  • dizziness
  • chills
  • nausea
  • vomiting
  • diarrhea
  • abdominal pain

Later, a person with HPS may develop coughing and shortness of breath caused by fluid buildup in the lungs. Such symptoms tend to develop 4 to 10 days after the earliest symptoms.

For some people, HPS can progress to respiratory failure and death. The mortality rate for HPS is high but can depend on the virus you have and where you are. According to the Centers for Disease Control and Prevention (CDC), is fatal in about 38% of people who contract it.

Hemorrhagic fever with renal syndrome (HFRS)

HFRS is a serious disease with early symptoms that resemble those of HPS. Symptoms usually develop in 2 to 4 weeks, but they can take up to 8 weeks to appear.

Once they appear, early flu-like symptoms last for 1 to 7 days. After that, more serious symptoms can develop. These include:

Some of the hantavirus strains known to cause HFRS can be fatal in up to 15% of people who contract it.

Even after recovering from the most serious symptoms, you may still experience mild symptoms for another 3 to 6 months.

People who come into contact with rodents carrying hantavirus are at risk of infection. Because different hantaviruses exist worldwide, the risk of infection exists for most people, though infections tend to be sporadic. But some people may be more prone than others.

You may be at higher risk of hantavirus infection if:

  • You live in a rural area where farms, fields, and forests serve as habitats for rodents who carry hantavirus.
  • You have a barn, shed, garage, basement, or other extension or part of your house that rodents use.
  • You have a rodent infestation inside of your house.
  • You often engage in activities where you might come into contact with rodent droppings, urine, saliva, or nesting materials.
  • You often engage in activities where you might stir the virus into the air, such as cleaning with a vacuum or gardening with a rake in areas where rodents live or have lived.
  • You’re cleaning or opening a long-unused building that rodents may inhabit.
  • You’re a construction, utility, or pest control worker who may come into contact with rodents, especially in small or unventilated crawlspaces.
  • You often camp or hike, especially if you use infested trail shelters or camp in other rodent habitats.

Overall, males appear to be more at risk. This is likely due to a higher percentage of males being involved in at-risk activities.

People 70 years old and older seem to be at greater risk of more serious disease and death.

It’s important for a doctor to diagnose a hantavirus infection early. Early diagnosis can help ensure the best possible treatment and outcome.

But it can be challenging to diagnose early hantavirus. The early symptoms tend to resemble symptoms of the flu or coronavirus disease 19 (COVID-19). If you have a fever and shortness of breath, along with a history of potential rodent exposure, you may have a hantavirus infection.

If you’re experiencing flu-like symptoms and think you’ve recently been exposed to rodents, it’s important to bring this up with a doctor. They can order an enzyme-linked immunosorbent assay (ELISA) to confirm hantavirus.

A doctor may also order the following tests to look for other symptoms:

Hantavirus infection can progress into severe disease. The goal of treatment for hantavirus is to manage your symptoms to lower the risk of damage to your lungs and heart.

Due to severe pulmonary (lung) symptoms, many people will need help breathing. About 40% of people who go to the hospital with hantavirus symptoms require mechanical ventilation. If your symptoms don’t improve, your medical team might try extracorporeal membrane oxygenation (ECMO).

People who develop HFRS may require hemodialysis. This is a way to filter your blood until your kidneys recover.

A doctor may consider prescribing antiviral medication to help remove the virus from your system. No large human trial has shown any antiviral to be effective at treating various hantavirus strains. But some studies have seen positive results.

  • Ribavirin: Some studies suggest that ribavirin effectively treats the Hantaan and Andes viruses. But these effects seem to be useful only before pulmonary symptoms begin. It also has significant side effects. A 2021 animal study found positive results when using ribavirin together with favipiravir to treat the Hantaan virus.
  • Chloroquine: Known as an antimalaria drug, chloroquine has been seen to be effective against the Hantaan and Andes viruses in studies with rodents. There have been no human trials.
  • Monoclonal antibodies: Recent research suggests that monoclonal (human-made) antibodies could prevent infection from the Andes and Puumala viruses in rodents.

Note that these treatments are still being investigated. There’s no FDA-approved treatment for hantavirus.

The best way to prevent hantavirus infection is to lower your risk of exposure to rodents and the various ways they spread disease. Some tips include:

  • Wash your hands after spending time outdoors, such as when hiking. Wash them frequently when doing prolonged outdoor activities such as camping.
  • When camping, keep food and food supplies, as well as trash, contained and covered.
  • Avoid touching rodents or their urine or droppings. If you come into contact, wash your hands afterward.

About half of all infections stem from exposure to the virus around your home. There are steps you can take to protect your home as well.

  • Close up potential rodent entryways into your home.
  • Set traps or hire a pest control professional if you have a rodent infestation.
  • When cleaning an area potentially occupied by rodents, wear a properly fitting respirator mask (such as an N95) and gloves.
  • Keep your kitchen clean and store food off the counters to deter rodents.

Hantavirus is a rare but serious disease. Below are the answers to some common questions about hantavirus.

How long does it take for hantavirus symptoms to show?

Symptoms of hantavirus can start emerging around 1 week following exposure. But some people may not see symptoms until up to 8 weeks after exposure.

How long do hantavirus symptoms last?

The early stage of hantavirus symptoms can last up to 10 days. Symptoms can then progress rapidly.

If your hantavirus infection leads to HFRS and affects your kidneys, the most serious symptoms can last from 2 to 6 days. There will be another 2 weeks where you start to recover. But mild symptoms can linger for up to 1 year in some people.

Can humans transmit hantavirus?

Scientists haven’t observed human-to-human transmission of the hantaviruses that circulate in the United States. This means you can’t catch the disease from being around or interacting with someone who has the virus.

The Andes virus, found in South America, is the only hantavirus known to show human-to-human transmission.

Does hantavirus affect your brain?

Very early research suggested a link between HPS and reduced memory or cognitive impairment. Researchers at the time thought that hantavirus might damage your brain directly.

Recent research suggests that the Puumala virus may affect your central nervous system (CNS). Researchers found that people who developed a mild form of HFRS experienced CNS symptoms such as headache, insomnia, and vertigo. This may be due to the virus damaging people’s blood-brain barrier, but this isn’t clearly understood.

Is there a hantavirus vaccine?

There’s no vaccine for hantavirus available in the United States. While there have been many vaccine candidates, none have yet to be seen as effective or to surpass early clinical trials.

Hantaviruses are rare but serious diseases carried by rodents and transmitted to humans worldwide. Hantaviruses cause a progression of flu-like symptoms followed by respiratory symptoms that can be severe or fatal.

Some people’s infections of hantavirus may progress into HPS, a serious lung-related complication. Some develop into HFRS, a kidney-related complication.

The focus of hantavirus treatment is supportive care to manage your symptoms and prevent damage to your body.

The best way to prevent hantavirus is to avoid contact with rodents and their urine, droppings, and nesting materials.

Source link

Cystic Fibrosis - Drug Pipeline Landscape, 2022 - Overview,

New York, Global Cystic Fibrosis - Drug Pipeline Landscape, 2022 report from Global Insight Services is the single authoritative source of intelligence on Cystic Fibrosis - Drug Pipeline Landscape, 2022. The report will provide you with analysis of impact of latest market disruptions such as Russia-Ukraine war and Covid-19 on the market. Report provides qualitative analysis of the market using various frameworks such as Porters' and PESTLE analysis. Report includes in-depth segmentation and market size data by categories, product types, applications, and geographies. Report also includes comprehensive analysis of key issues, trends and drivers, restraints and challenges, competitive landscape, as well as recent events such as M&A activities in the market.

Read more about Cystic Fibrosis - Drug Pipeline Landscape, 2022 here: www.globalinsightservices.com/reports/cystic-fibrosis-drug-pipeline-landscape-2022/

Cystic Fibrosis (CF) is a progressive, genetic disease that causes persistent lung infections and limits the ability to breathe over time. In people with CF, a defective gene causes a thick, sticky buildup of mucus in the lungs, pancreas, and other organs. In the lungs, the mucus clogs the airways and traps bacteria leading to infections, extensive lung damage, and eventually, respiratory failure. In the pancreas, the mucus prevents the release of digestive enzymes that the body needs to break down food and absorb vital nutrients.

In cystic fibrosis, a defect (mutation) in CFTR gene, changes a protein that regulates the movement of salt in and out of cells. Many different defects can occur in the gene. The type of gene mutation is associated with the severity of the condition.

Symptoms of Cystic Fibrosis include trouble with bowel movements or frequent, greasy stools, wheezing or trouble breathing, frequent lung infections, Infertility.

Healthcare providers diagnose cystic fibrosis with by using different tests including newborn screening, sweat test, genetic tests, chest X-rays, sinus X-rays, lung function tests and sputum culture.

Treatment of cystic fibrosis include medications, medications targeting genes, vest therapy, pulmonary rehabilitation, and surgical procedures.

Request free sample copy of this research study: www.globalinsightservices.com/request-sample/GIS31003/

Methodology
The research process includes extensive secondary research on public domain and other authentic sources to add or update the pipeline products information. The secondary research sources include, but are not limited to company websites, annual reports, financial reports, company pipeline chart, investor presentations and SEC filings, journals and conferences, and clinical trials registries.

Get Customized Report as Per Your Requirement: www.globalinsightservices.com/request-customization/GIS31003/

Scope
The pipeline landscape report provides analysis of pipeline products based on several stages of development ranging from Discovery to Pre-Registration. The report provides a review of pipeline therapeutics by companies based on information derived from company and industry-specific sources. The pipeline report covers assessment of therapeutics by mechanism of action (MoA), drug target, route of administration (RoA) and molecule type. Comprehensive profiles of the pipeline products with details such as company overview, development stage; molecule type, target, mechanism of action, route of administration, dosage form, regulatory designations, key deals, clincial trials, and key upcoming milestones are included.

Purchase your copy now: www.globalinsightservices.com/checkout/single_user/GIS31003/

With Global Insight Services, you receive:
- 10-year forecast to help you make strategic decisions
- In-depth segmentation which can be customized as per your requirements
- Free consultation with lead analyst of the report
- Excel data pack included with all report purchases
- Robust and transparent research methodology

About Global Insight Services:
Global Insight Services (GIS) is a leading multi-industry market research firm headquartered in Delaware, US. We are committed to providing our clients with highest quality data, analysis, and tools to meet all their market research needs. With GIS, you can be assured of the quality of the deliverables, robust & transparent research methodology, and superior service.

Contact Us:
Global Insight Services LLC
16192, Coastal Highway, Lewes DE 19958
E-mail: [email protected]
Phone: +1-833-761-1700

This release was published on openPR.

Source link

If you have panic disorder and feel like you need a stronger treatment than psychotherapy, the National Institute of Mental Health recommends consulting with a psychiatrist about getting a prescription for antidepressants. While these medications can be effective in treating panic disorders, you may feel uncomfortable side effects such as nausea or headaches. If you want to avoid these side effects and prefer a more natural approach, then CBD may be a treatment to check out.

Cannabidiol, otherwise known as CBD, is one of the two main active ingredients found in marijuana (per Medical News Today). Unlike delta-9-tetrahydrocannabinol (THC) though, CBD is not psychoactive. While you won't feel a "high" from CBD, there are several possible benefits CBD may offer that scientists are currently studying, from easing muscle inflammation to decreasing anxiety.

According to Cannabis and Cannabinoid Research, current research shows that when taken in low to moderate doses, CBD can reduce feelings of anxiety and panic. There's also a pending phase three clinical trial that will be examining the effect different dosages of CBD capsules, ranging in increments from 200 mg to 800 mg, can have in treating panic disorder (PD), agoraphobia, as well as generalized and social anxiety disorders. Current Neuropharmacology conducted a brain imaging study on healthy humans taking CBD and found that CBD presented "anti-panic" effects on the parts of the brain that are typically activated during a stress response in patients with PD.

Source link

A home-based exercise program had no effect on dyspnea in patients with chronic obstructive pulmonary disease (COPD) who had already completed pulmonary rehabilitation (PR); however, the program did improve exercise capacity and was beneficial based on patient reports. These were among study findings published in CHEST.

Most patients with COPD do not maintain gains made in exercise training during pulmonary rehabilitation. Researchers therefore conducted a clinical trial (HOMEX-1; ClinicalTrials.gov Identifier: NCT03461887) to develop and assess HOMEX, a structured, home-based strength training program for patients with COPD that patients can do following PR to maintain training effects of rehabilitation or on a stand-alone basis.

The randomized, parallel group, controlled trial enrolled 123 patients with COPD who had undergone PR at 1 of 4 Swiss PR clinics from January 2018 to March 2020. Participants were randomly assigned to either an intervention group (IG; n=61) receiving home-based exercise training or to a control group (CG; n=62) receiving no intervention/usual care. The average age was 66.8 (SD 8.1) years, 50% were female, and 75% had severe or very severe COPD.


Continue Reading

Participants in the IG were instructed to perform the training 6 days per week for about 20 minutes per day for 12 months. The primary outcome was change in dyspnea after 12 months as measured with the self-administered version of the Chronic Respiratory Questionnaire (CRQ) dyspnea domain; other outcomes included functional exercise capacity, patient-reported improvements and satisfaction, and cost-effectiveness. Of the cohort, 104 participants completed the 12-month follow-up assessments (53 IG, 51 CG).

For the IG group, CRQ dyspnea decreased from 4.65 (SD±1.33) at baseline to 4.42 (SD±1.49) at 12 months, and for the CG group CRQ dyspnea decreased from 4.61 (SD±1.27) to 4.06 (SD±1.45). No evidence was found for a between-group difference in change of CRQ dyspnea after 12 months in the intention-to-treat analysis (0.28; 95% CI, -0.23 to 0.80; P =.27).

No difference in the 6-minute walk test distance after 12 months was observed in the 2 groups (1.37; 95% CI, -35.06 to 37.79, P =.94). However, researchers found moderate evidence of improvement in the 1-minute-sit-to-stand-test in the IG group (2.6; 95% CI, 0.22-5.03; P =.033). For all other outcomes, no evidence of differences was observed between the 2 groups.

A total of 37 participants (70%) performed the training exercise until the study’s end and 42 (79%) for at least 10 months. In addition, 16 participants discontinued the training on average after 28 weeks (SD±14.6, range 1-46), 11 owing to health reasons and 5 for other reasons.

Regarding findings from the satisfaction survey, 81% of IG group participants reported that they much or very much liked participating in the program. Also, 41 participants (79%) reported seeing positive effects from the training. Analysis of cost-effectiveness found that the intervention was 44% likely to be cost-effective.

Among several study limitations was that some participants did not travel to the rehabilitation clinics for the follow-up assessment, thus requiring assessors to conduct home visits. In addition, the assessors were not blinded and changes in muscle strength were not objectively measured to quantify self-reported improvement in strength.

“Although we were not able to demonstrate statistical evidence for an effect of the HOMEX program on most objectively assessed outcomes, a vast majority of the IG participants reported that they experienced positive changes in daily life which they attributed to the training,” the study authors commented.

Reference

Frei A, Radtke T, Lana KD, et al. Effectiveness of a long-term home-based exercise training program in patients with COPD following pulmonary rehabilitation: a multi-center randomized controlled trial. Chest. Published online August 8, 2022. doi:10.1016/j.chest.2022.07.026

Source link

ORLANDO, Fla.--()--Mayo Clinic released the results of a clinical trial demonstrating the positive outcomes of a Comprehensive Wellness Program for reducing stress and improving resilience among healthcare professionals. Integral to the study was the participants’ use of BREATHER FIT®, one of PN Medical's Combined Respiratory Muscle Training (cRMT) devices.

Participants in the study received an Oura Ring® and a BREATHER FIT® device, educational materials, situational breathing strategies, virtual education sessions, and weekly emailed recommendations to participate in the intervention for four weeks. Participation criteria included employment at Mayo Clinic serving front line patients and having access to a smart device they would be willing to utilize for study participation.

“Specifically, we looked at the impact of this program on stress and sleep, with doctors and others on the front line of healthcare,” said Brent Bauer, M.D., from Mayo Clinic. “I don’t know if it surprised me…I think it reassured me that these busy physicians could find five minutes, twice a day to do a pretty basic respiratory muscle training and actually get a significant impact on their anxiety and stress levels.”

Pre-2020, hospitals and clinics were already facing a crisis with physicians as front line workers attending to life and death situations, but the Covid-19 Pandemic took it to a level never seen before. This study sought to answer the question, what else can we do to help essential front line personnel survive and thrive in such demanding positions?

A relatively simple, drug-free breathing technique showed a very big impact. The study found that participants generally experienced favorable results and stress was reduced by an average of 18%. The study also examined sleep and depression.

The idea of resilience is not unique to healthcare providers; it is something that is needed by everyone in and out of the workplace.

“Through all of our diverse research studies with NATO pilots, professional athletes, COPD patients, opera singers and many other groups of people, we consistently see how The BREATHER® strengthens your respiratory system and contributes to longevity and wellbeing,” said Mark Carbone, CEO of PN Medical. “This also supports findings from other studies like one from Colorado University Boulder published last year in The Journal of The American Heart Association that demonstrated RMT’s impact on lowering blood pressure as effectively as traditional exercise or drugs.”

About PN Medical, Inc.

PN Medical is a leader in respiratory care and research, creating the world’s first Combined Respiratory Muscle Training (cRMT) device more than 40 years ago. Through their products, education, research, and technology, they’ve helped more than 1.6 million people recover from respiratory and cardiovascular conditions; improve human performance; reduce stress and anxiety; and find relief and resilience from COVID. The benefits of The BREATHER® are hoped to help the 120 million people suffering from Long-Covid. Read full clinical trial results here

Source link

(SACRAMENTO)

Just three years ago, Patrisa Williams, who has chronic obstructive pulmonary disease (COPD), could not breathe without using her oxygen tank. Now, she’s hiking regularly with her grandchildren.

The dramatic improvement is thanks to a minimally invasive endobronchial valve placement she received at UC Davis Health – one of the first such procedures done in Northern California.

One of 16 million Americans diagnosed with COPD, Williams had difficulty breathing despite optimal medical therapy, pulmonary rehabilitation and even supplemental oxygen. COPD refers to a group of diseases that cause shortness of breath in part because areas within the lungs are diseased and holding trapped air (hyperinflation of the lung).

Williams has the emphysematous form of COPD. Patients with this type of COPD can have severe hyperinflation, leading to impairment of the muscles that drive breathing. This makes it difficult to inhale and fill the lungs with new air. COPD can limit a patient's ability to work or even do simple daily tasks.

“I needed to be attached to my portable oxygen tank 24/7,” recalled Williams. “I could not do anything without it. My blood oxygen levels would drop too low. I felt trapped and desperately wanted to find a way to have some sort of normalcy.”

Before Patrisa's procedure her upper lobes had significantly more emphysema leading to compression of the lower lobes. The endobronchial valves collapsed the right upper lobe allowing more room for her lungs to ventilate.

Two images of Patrisa Williams lungs showing emphysema
Before Patrisa's procedure her upper lobes had significantly more emphysema leading to compression of the lower lobes. The endobronchial valves collapsed the right upper lobe allowing more room for her lungs to ventilate.

Seeking treatment

To find a solution, Williams sought care with UC Davis Health. She met with Michael Schivo, co-director of the Comprehensive COPD Clinic, to optimize her care and to be evaluated for a procedure newly approved by the FDA to treat the emphysematous form of COPD. After a thorough discussion of her case at a UC Davis Interventional Therapeutics Board Committee meeting, she was referred to interventional pulmonologist Ken Yoneda for a final evaluation before her procedure.

Blonde haired woman smiling with mountains in the background
Following her procedure, Patrisa Williams is now able to hike and spend quality time with her grandchildren.

“At that time, we had recently concluded our participation in a large multi-centered clinical trial for endobronchial valve placement. It was the pivotal study that led the FDA to approve a minimally invasive procedure which places tiny valves in the airways allowing the healthier part of the lungs to expand,” Yoneda explained. “We are highly selective of the patients we choose for this procedure, but Patrisa met all our criteria.”

UC Davis Health is one of the few institutions in California performing endobronchial valve placement procedures. Patients who meet the minimum criteria for the procedure:

  • Have a confirmed diagnosis of COPD with emphysema
  • Have hyperinflated lungs
  • Are not eligible for a lung transplant

Williams became the first patient treated with this procedure at UC Davis and one of the first in Northern California.

Endobronchial valve placement procedure

During the procedure, a standard bronchoscope and flexible delivery catheter are used to guide the valves into the target lobe and desired airway. Multiple valves are implanted to ensure complete occlusion of all airways leading to the target lobe of the lung. Valves may be placed at the lobar, segmental or subsegmental levels depending on the airway anatomy.

Once placed, the valve closes when the person inhales, keeping air out of the diseased area of the lung. It opens when the person exhales, allowing air to exit the lung and reducing the shortness of breath that occurs when the damaged part of the lung works hard to try to take in and push out air. By closing the diseased parts of the lungs off from the respiratory process, the endobronchial valve allows the healthier parts of the lungs to do their job better.

“For patients with limited respiratory function, the procedure provides improvements when inhaled medications and rehabilitation don’t,” Yoneda explained. “After treatment, the remaining lobes can now expand more fully and pressure on the diaphragm is relieved, improving their breathing mechanics and overall lung function. However, I can’t stress enough that patient selection and optimal COPD treatment are of paramount importance to the success of this procedure. Our COPD pulmonologists Brooks Kuhn and Michael Schivo are the cornerstone of that process.”

Ken Yoneda

For patients with limited respiratory function, the procedure provides improvements when inhaled medications and rehabilitation don’t.”Ken Yoneda

Improved quality of life

Following her procedure, Williams spent three nights recovering in the hospital. She spent much of her time resting in bed.

“The biggest risk for a patient following the procedure is a pneumothorax, so we monitor them closely and take a daily chest x-ray to make sure they are doing well,” Yoneda said. “We try to limit what they do, to stay in bed, and not cough for the first 24 hours. Then slowly, and over the next three days, we get them moving around.”

When Williams returned home, she restarted pulmonary rehabilitation and exercising. Just five months after the procedure, she began hiking and has not looked back.

Since my procedure, I have not needed to use oxygen at all. I can breathe so much better. For me, it was a miracle. It has given me back the quality of life I was lacking.” Patrisa Williams

“Since my procedure, I have not needed to use oxygen at all,” Williams explained. “I can breathe so much better. For me, it was a miracle. It has given me back the quality of life I was lacking.”

Williams is grateful to everyone at UC Davis Health – from Yoneda, to the lung navigator who coordinated her care, to each nurse, technician and food service team member she encountered.

“Their entire team made it so easy for me. It was like they held my hand through the entire process,” she recalled. “Dr. Yoneda is the most caring doctor. He even called me when I got home to check on me. That personal touch made such a difference in the care I received.”

Source link

Pfizer announced Thursday that its vaccine candidate for respiratory syncytial virus was more than 85% effective in preventing lower respiratory tract illness in older adults.

The New York-based pharmaceutical company released findings from the Phase 3 clinical trial investigating its RSV vaccine candidate when administered to participants ages 60 and up. The investigational vaccine targets both A and B strains of the virus, making it bivalent.

"We are delighted that this first bivalent RSV vaccine candidate, RSVpreF, was demonstrated to be efficacious in our clinical trial against this disease, which is associated with high levels of morbidity and mortality in older adults," Dr. Annaliesa Anderson, senior vice president and chief scientific officer for vaccine research and development at Pfizer, said in a statement Thursday.

RSV is a common virus that affects the lungs and breathing passages, usually causing mild, cold-like symptoms but sometimes leading to serious conditions. Although most people recover within a week or two, the virus can be dangerous, especially for infants and older adults, according to the Centers for Disease Control and Prevention.

Each year, an estimated 177,000 older adults are hospitalized with RSV across the United States and 14,000 of them die. The virus is the most common cause of bronchiolitis and pneumonia in children under the age of 1 in the U.S. There is currently no approved vaccine for RSV, according to the CDC.

Four companies -- Pfizer, GSK, Johnson & Johnson and Moderna -- are in late-stage trials for their respective RSV vaccine candidates.

Pfizer said in a press release Thursday that a vaccine efficacy of 85.7% was observed in participants with more severe primary disease endpoint of lower respiratory tract illness, or LRTI-RSV, defined by analysis of three or more RSV-associated symptoms. The investigational vaccine was also well-tolerated, with no safety concerns, according to the press release.

Based on the findings, Pfizer said it plans to seek regulatory approval from the U.S. Food and Drug Administration this fall.

"Scientists and researchers have worked to develop RSV vaccines with little success for over half a century," Anderson added. "These findings are an important step in our effort to help protect against RSV disease and we look forward to working with the FDA and other regulatory agencies to make this vaccine candidate available to help address the substantial burden of RSV disease in older adults."

Copyright © 2022 ABC News Internet Ventures.



Source link


Get instant alerts when news breaks on your stocks. Claim your 1-week free trial to StreetInsider Premium here.


Pfizer Inc. (NYSE: PFE) today announced positive top-line data from the Phase 3 clinical trial (NCT05035212) RENOIR (RSV vaccine Efficacy study iN Older adults Immunized against RSV disease) investigating its bivalent RSV prefusion F vaccine candidate, RSVpreF, when administered to adults 60 years of age or older. The bivalent vaccine candidate is composed of two preF proteins selected to optimize protection against RSV A and B strains.

RSV disease is characterized by several respiratory symptoms varying from mild to more severe disease, with more severe disease having more symptoms. A pre-planned, interim analysis of Pfizer’s RSVpreF efficacy conducted by an independent, external Data Monitoring Committee (DMC) to assess protection against RSV-associated lower respiratory tract illness (LRTI-RSV) defined by two or more symptoms demonstrated vaccine efficacy: 66.7% (96.66% CI: 28.8%, 85.8%). This positive result enabled Pfizer to look at the more severe disease primary endpoint of LRTI-RSV defined by three or more symptoms, where vaccine efficacy of 85.7% (96.66% CI: 32.0%, 98.7%) was observed. The DMC also indicated the investigational vaccine was well-tolerated, with no safety concerns. Based on these results, Pfizer plans to submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for RSVpreF and to prepare submissions for other regulatory authorities in the coming months.

“We are delighted that this first bivalent RSV vaccine candidate, RSVpreF, was observed to be efficacious in our clinical trial against this disease, which is associated with high levels of morbidity and mortality in older adults,” said Annaliesa Anderson, Ph.D., Senior Vice President and Chief Scientific Officer, Vaccine Research and Development, Pfizer. “Scientists and researchers have worked to develop RSV vaccines with little success for over half a century. These findings are an important step in our effort to help protect against RSV disease, and we look forward to working with the FDA and other regulatory agencies to make this vaccine candidate available to help address the substantial burden of RSV disease in older adults."

Pfizer intends to present results of this interim analysis at a future medical congress and will submit the results for peer-review in a scientific journal.

The Phase 3 RENOIR trial is a global, randomized, double-blind, placebo-controlled study designed to assess the efficacy, immunogenicity, and safety of a single dose of RSVpreF in adults 60 years of age and older. To date, RENOIR has enrolled approximately 37,000 participants, randomized to receive 120μg RSVpreF or placebo in a 1:1 ratio. Enrollment up to approximately 40,000 participants continues in the Southern Hemisphere to accumulate cases during their first season.

Burden of RSV in Older Adults

RSV is a contagious virus that in healthy individuals can cause serious respiratory illness.1 The virus can affect the lungs and breathing passages of an infected individual and can be potentially life-threatening for older adults and adults with certain medical conditions.2,3,4 Each year it is estimated that 336,000 older adults are hospitalized globally due to RSV.5 In the United States alone, RSV infections in older adults account for approximately 177,000 hospitalizations and 14,000 deaths each year.4

RSV is a disease for which there are currently no prophylactic or therapeutic options for older adults and the medical community is limited to offering only supportive care for adults with the illness.

About RSVpreF

Pfizer’s investigational RSV vaccine candidate builds on foundational basic science discoveries including those made at the National Institutes of Health (NIH), which detailed the crystal structure of prefusion F, a key form of the viral fusion protein (F) that RSV uses to enter human cells. The NIH research showed that antibodies specific to the prefusion form were highly effective at blocking virus infection, suggesting a prefusion F-based vaccine may confer optimal protection against RSV. After this important discovery, Pfizer tested numerous versions of a stabilized prefusion F protein and identified a candidate that elicited a strong anti-viral immune response in pre-clinical evaluations. The bivalent vaccine candidate is composed of equal amounts of recombinant RSV prefusion F from subgroups A and B.

In addition to the investigational older adult vaccination program, in March 2022, Pfizer announced RSVpreF received Breakthrough Therapy Designation from the FDA for the prevention of RSV-associated lower respiratory tract disease caused by RSV in infants from birth up to six months of age by active immunization of pregnant women. The FDA designation was primarily informed by the results of the Phase 2b proof-of-concept study of RSVpreF (NCT04032093), a global, double-blinded, placebo-controlled study that assessed the safety and immunogenicity of RSVpreF in healthy pregnant women ages 18 through 49 years old, who were vaccinated between 28- and 36-weeks gestation, and their infants.

In June 2020, Pfizer announced the initiation of a multicenter, international Phase 3 clinical trial (NCT04424316), MATISSE (MATernal Immunization Study for Safety and Efficacy), evaluating the efficacy and safety of a single dose of RSVpreF when administered to pregnant individuals to help protect their babies from RSV after birth. This study remains ongoing.

About Pfizer: Breakthroughs That Change Patients’ Lives

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.

DISCLOSURE NOTICE:

The information contained in this release is as of August 25, 2022. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

This release contains forward-looking information about Pfizer’s respiratory syncytial virus vaccine candidate (RSVpreF), including its potential benefits and planned regulatory submissions for the prevention of RSV-associated lower respiratory tract disease in individuals 60 years of age or older, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; risks associated with interim data, including the risk that final results from the Phase 3 trial could differ from the interim data discussed in this release; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when biologic license applications may be filed in any jurisdictions for RSVpreF for any potential indications (including the planned BLA submission in the U.S.); whether and when any such applications may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the product's benefits outweigh its known risks and determination of the product's efficacy and, if approved, whether RSVpreF will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of RSVpreF; uncertainties regarding the ability to obtain recommendations from vaccine advisory or technical committees and other public health authorities regarding RSVpreF and uncertainties regarding the commercial impact of any such recommendations; uncertainties regarding the impact of COVID-19 on our business, operations and financial results; and competitive developments.

A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2021 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com.

_____________________________
1 Centers for Disease Control and Prevention. Respiratory Syncytial Virus Infection (RSV). www.cdc.gov/rsv/index.html. Updated December 18, 2020. Accessed February 22, 2022.
2 Centers for Disease Control and Prevention. RSV in Older Adults and Adults with Chronic Medical Conditions. www.cdc.gov/rsv/high-risk/older-adults.html. Updated December 18, 2020. Accessed July 22, 2022.
3 Centers for Disease Control and Prevention. RSV Transmission. www.cdc.gov/rsv/about/transmission.html. Updated December 18, 2020. Accessed February 22, 2022.
4 Centers for Disease Control and Prevention. Respiratory Syncytial Virus Infection (RSV) – Older Adults are at High Risk for Severe RSV Infection Fact Sheet. www.cdc.gov/rsv/factsheet-older-adults.pdf. Accessed February 10, 2022.
5 Shi T, Denouel A, Tietjen AK, et al. Global Disease Burden Estimates of Respiratory Syncytial Virus-Associated Acute Respiratory Infection in Older Adults in 2015: A Systematic Review and Meta-Analysis. J Infect Dis. 2020;222(Suppl 7):S577-S583. doi:10.1093/infdis/jiz059.

Category: Vaccines

Media:

[email protected]

+1 (212) 733-1226

Investors:

[email protected]

+1 (212) 733-4848

Source: Pfizer Inc.



Source link

  • Vaccine efficacy of 85.7% was observed in participants with more severe disease primary endpoint of lower respiratory tract illness (LRTI-RSV) defined by analysis of three or more RSV-associated symptoms
  • Investigational vaccine was well-tolerated with no safety concerns
  • Based on the findings of this pre-planned, interim efficacy analysis, Pfizer intends to submitfor regulatory approval in fall 2022

NEW YORK--(BUSINESS WIRE)--
Pfizer Inc. (NYSE: PFE) today announced positive top-line data from the Phase 3 clinical trial (NCT05035212) RENOIR (RSV vaccine Efficacy study iNOlder adults Immunized against RSV disease) investigating its bivalent RSV prefusion F vaccine candidate, RSVpreF, when administered to adults 60 years of age or older. The bivalent vaccine candidate is composed of two preF proteins selected to optimize protection against RSV A and B strains.

RSV disease is characterized by several respiratory symptoms varying from mild to more severe disease, with more severe disease having more symptoms. A pre-planned, interim analysis of Pfizer’s RSVpreF efficacy conducted by an independent, external Data Monitoring Committee (DMC) to assess protection against RSV-associated lower respiratory tract illness (LRTI-RSV) defined by two or more symptoms demonstrated vaccine efficacy: 66.7% (96.66% CI: 28.8%, 85.8%). This positive result enabled Pfizer to look at the more severe disease primary endpoint of LRTI-RSV defined by three or more symptoms, where vaccine efficacy of 85.7% (96.66% CI: 32.0%, 98.7%) was observed. The DMC also indicated the investigational vaccine was well-tolerated, with no safety concerns. Based on these results, Pfizer plans to submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for RSVpreF and to prepare submissions for other regulatory authorities in the coming months.

“We are delighted that this first bivalent RSV vaccine candidate, RSVpreF, was observed to be efficacious in our clinical trial against this disease, which is associated with high levels of morbidity and mortality in older adults,” said Annaliesa Anderson, Ph.D., Senior Vice President and Chief Scientific Officer, Vaccine Research and Development, Pfizer. “Scientists and researchers have worked to develop RSV vaccines with little success for over half a century. These findings are an important step in our effort to help protect against RSV disease, and we look forward to working with the FDA and other regulatory agencies to make this vaccine candidate available to help address the substantial burden of RSV disease in older adults."

Pfizer intends to present results of this interim analysis at a future medical congress and will submit the results for peer-review in a scientific journal.

The Phase 3 RENOIR trial is a global, randomized, double-blind, placebo-controlled study designed to assess the efficacy, immunogenicity, and safety of a single dose of RSVpreF in adults 60 years of age and older. To date, RENOIR has enrolled approximately 37,000 participants, randomized to receive 120μg RSVpreF or placebo in a 1:1 ratio. Enrollment up to approximately 40,000 participants continues in the Southern Hemisphere to accumulate cases during their first season.

Burden of RSV in Older Adults

RSV is a contagious virus that in healthy individuals can cause serious respiratory illness.1 The virus can affect the lungs and breathing passages of an infected individual and can be potentially life-threatening for older adults and adults with certain medical conditions.2,3,4 Each year it is estimated that 336,000 older adults are hospitalized globally due to RSV.5 In the United States alone, RSV infections in older adults account for approximately 177,000 hospitalizations and 14,000 deaths each year.4

RSV is a disease for which there are currently no prophylactic or therapeutic options for older adults and the medical community is limited to offering only supportive care for adults with the illness.

About RSVpreF

Pfizer’s investigational RSV vaccine candidate builds on foundational basic science discoveries including those made at the National Institutes of Health (NIH), which detailed the crystal structure of prefusion F, a key form of the viral fusion protein (F) that RSV uses to enter human cells. The NIH research showed that antibodies specific to the prefusion form were highly effective at blocking virus infection, suggesting a prefusion F-based vaccine may confer optimal protection against RSV. After this important discovery, Pfizer tested numerous versions of a stabilized prefusion F protein and identified a candidate that elicited a strong anti-viral immune response in pre-clinical evaluations. The bivalent vaccine candidate is composed of equal amounts of recombinant RSV prefusion F from subgroups A and B.

In addition to the investigational older adult vaccination program, in March 2022, Pfizer announced RSVpreF received Breakthrough Therapy Designation from the FDA for the prevention of RSV-associated lower respiratory tract disease caused by RSV in infants from birth up to six months of age by active immunization of pregnant women. The FDA designation was primarily informed by the results of the Phase 2b proof-of-concept study of RSVpreF (NCT04032093), a global, double-blinded, placebo-controlled study that assessed the safety and immunogenicity of RSVpreF in healthy pregnant women ages 18 through 49 years old, who were vaccinated between 28- and 36-weeks gestation, and their infants.

In June 2020, Pfizer announced the initiation of a multicenter, international Phase 3 clinical trial (NCT04424316), MATISSE (MATernal Immunization Study for Safety and Efficacy), evaluating the efficacy and safety of a single dose of RSVpreF when administered to pregnant individuals to help protect their babies from RSV after birth. This study remains ongoing.

About Pfizer: Breakthroughs That Change Patients’ Lives

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.

DISCLOSURE NOTICE:

The information contained in this release is as of August 25, 2022. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

This release contains forward-looking information about Pfizer’s respiratory syncytial virus vaccine candidate (RSVpreF), including its potential benefits and planned regulatory submissions for the prevention of RSV-associated lower respiratory tract disease in individuals 60 years of age or older, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; risks associated with interim data, including the risk that final results from the Phase 3 trial could differ from the interim data discussed in this release; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when biologic license applications may be filed in any jurisdictions for RSVpreF for any potential indications (including the planned BLA submission in the U.S.); whether and when any such applications may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the product's benefits outweigh its known risks and determination of the product's efficacy and, if approved, whether RSVpreF will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of RSVpreF; uncertainties regarding the ability to obtain recommendations from vaccine advisory or technical committees and other public health authorities regarding RSVpreF and uncertainties regarding the commercial impact of any such recommendations; uncertainties regarding the impact of COVID-19 on our business, operations and financial results; and competitive developments.

A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2021 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com.

_____________________________

1 Centers for Disease Control and Prevention. Respiratory Syncytial Virus Infection (RSV). www.cdc.gov/rsv/index.html. Updated December 18, 2020. Accessed February 22, 2022.

2 Centers for Disease Control and Prevention. RSV in Older Adults and Adults with Chronic Medical Conditions. www.cdc.gov/rsv/high-risk/older-adults.html. Updated December 18, 2020. Accessed July 22, 2022.

3 Centers for Disease Control and Prevention. RSV Transmission. www.cdc.gov/rsv/about/transmission.html. Updated December 18, 2020. Accessed February 22, 2022.

4 Centers for Disease Control and Prevention. Respiratory Syncytial Virus Infection (RSV) – Older Adults are at High Risk for Severe RSV Infection Fact Sheet. www.cdc.gov/rsv/factsheet-older-adults.pdf. Accessed February 10, 2022.

5 Shi T, Denouel A, Tietjen AK, et al. Global Disease Burden Estimates of Respiratory Syncytial Virus-Associated Acute Respiratory Infection in Older Adults in 2015: A Systematic Review and Meta-Analysis. J Infect Dis. 2020;222(Suppl 7):S577-S583. doi:10.1093/infdis/jiz059.

Category: Vaccines

Media:

[email protected]

+1 (212) 733-1226

Investors:

[email protected]

+1 (212) 733-4848

Source: Pfizer Inc.

Source link

The Brief Psychiatric Rating Scale (BPRS) was an effective tool for measuring general and specific psychiatric symptoms across the diagnostic spectrum, based on data from 600 psychiatric inpatients.

"Current DSM and ICD diagnoses do not depict psychopathology accurately, therefore their validity in research and utility in clinical practice is questioned," wrote Andreas B. Hofmann, PhD, of the University of Zürich and colleagues.

The BPRS was developed to assess changes in psychopathology across a range of severe psychiatric disorders, but its potential to assess symptoms in nonpsychotic disorders has not been explored, the researchers said.

In a study published in Psychiatry Research, the investigators analyzed data from 600 adult psychiatric inpatients divided equally into six diagnostic categories: alcohol use disorder, major depressive disorder, anxiety disorders, bipolar disorder, schizophrenia, and personality disorders. The mean age of the patients was 41.5 years and 45.5% were women. The demographic characteristics were similar across most groups, although patients with a personality disorder were significantly more likely than other patients to be younger and female.

Patients were assessed using the BPRS based on their main diagnosis. The mini-ICF-APP, another validated measure for assessing psychiatric disorders, served as a comparator, and both were compared to the Clinical Global Impression Scale (CGI).

Overall, the BPRS and mini-ICF-APP showed moderate correlation and good agreement, the researchers said. The Pearson correlation coefficient for the BPRS and mini-ICF-APP scales was 0.53 and the concordance correlation coefficient was 0.52. The mean sum scores for the BPRS, the mini-ICF-APP, and the CGI were 45.4 (standard deviation, 14.4), 19.93 (SD, 8.21), and 5.55 (SD, 0.84), respectively, which indicated "markedly ill" to "severely ill" patients, the researchers said.

The researchers were able to detect three clusters of symptoms corresponding to externalizing, internalizing, and thought disturbance domains using the BPRS, and four clusters using the mini-ICF-APP.

The symptoms using BPRS and the functionality domains using the mini-ICF-APP "showed a close interplay," the researchers noted.

"The symptoms and functional domains we found to be central within the network structure are among the first targets of any psychiatric or psychotherapeutic intervention, namely the building of a common language and understanding as well as the establishment of confidence in relationships and a trustworthy therapeutic alliance," they wrote in their discussion.

The study findings were limited by several factors including the collection of data from routine practice rather than clinical trials, the focus on only the main diagnosis without comorbidities, and the inclusion only of patients requiring hospitalization, the researchers noted.

However, the results were strengthened by the large sample size, and demonstrate the validity of the BPRS as a measurement tool across a range of psychiatric diagnoses, they said.

"Since the BPRS is a widely known and readily available psychometric scale, our results support its use as a transdiagnostic measurement instrument of psychopathology," they concluded.

The study received no outside funding. The researchers had no financial conflicts to disclose.

This article originally appeared on MDedge.com, part of the Medscape Professional Network.

Source link

A compelling new study indicates Parkinson’s disease (PD) could be diagnosed by remotely tracking a person’s breathing patterns. Led by researchers from MIT, the study presents an AI system that uses radio waves to monitor breathing while a person sleeps.

Dina Katabi, principal investigator on the new research, said the study was inspired by 200-year-old observations from James Parkinson, the first doctor to clinically catalog signs of the degenerative neurological disease.

“A relationship between Parkinson’s and breathing was noted as early as 1817, in the work of Dr. James Parkinson,” explained Katabi. “This motivated us to consider the potential of detecting the disease from one’s breathing without looking at movements. Some medical studies have shown that respiratory symptoms manifest years before motor symptoms, meaning that breathing attributes could be promising for risk assessment prior to Parkinson’s diagnosis.”

The first step was to train a neural network on a massive nocturnal breathing dataset. Nearly 12,000 nights of breathing patterns were analyzed, from 757 Parkinson’s disease patients and around 7,000 healthy control subjects.

Testing the AI model on an independent dataset it was able to diagnose Parkinson’s patients with 86% accuracy from just one night of data. On average, the study found 12 nights of consecutive tracking could reach around 95% accuracy at diagnosing Parkinson’s.

Even more interesting is the system’s potential for diagnosing Parkinson’s disease before any motor symptoms appear. The dataset studied included data from subjects before and after a Parkinson’s diagnosis. The two sleep visits were around six years apart and the AI model could predict Parkinson’s in the undiagnosed cohort with 75% accuracy from the first set of sleep data, before a patient was diagnosed with Parkinson's.

“Currently, diagnosis of PD is based on the presence of clinical motor symptoms, which are estimated to develop after 50–80% of dopaminergic neurons have already degenerated,” the researchers write in the study. “Our system shows initial evidence that it could potentially provide risk assessment before clinical motor symptoms.”

More work is of course needed to validate the system as an early diagnostic tool, but a more immediate use could be in tracking disease progression. Other data analyzed in the study showed the AI model can track a Parkinson’s patient over 12 months and correlate changes in breathing patterns with increases in disease severity.

According to Katabi, this could have uses in a variety of contexts, from improving clinical care for patients living in remote environments to helping researchers evaluate the efficacy of new drug treatments in clinical trials.

“In terms of drug development, the results can enable clinical trials with a significantly shorter duration and fewer participants, ultimately accelerating the development of new therapies,” Katabi said. “In terms of clinical care, the approach can help in the assessment of Parkinson’s patients in traditionally underserved communities, including those who live in rural areas and those with difficulty leaving home due to limited mobility or cognitive impairment.”

It’s early days, but the researchers have already developed a wall-mounted device that can be used to monitor patients in their home. Ultimately this kind of device could act as an early-warning system for people at a higher-than-average risk of developing Parkinson’s, or early-stage patients wanting close monitoring of their disease progression.

“We envision that the system could eventually be deployed in the homes of PD patients and individuals at high risk for PD (for example, those with LRRK2 gene mutation) to passively monitor their status and provide feedback to their provider,” the researchers speculated in the new study. “If the model detects severity escalation in PD patients, or conversion to PD in high-risk individuals, the clinician could follow up with the patient to confirm the results either via telehealth or a visit to the clinic.”

The new study was published in Nature Medicine.

Source: MIT



Source link

August 10, 2022

1 min read


We were unable to process your request. Please try again later. If you continue to have this issue please contact [email protected].

Remote patient monitoring with health coaching improved quality of life, self-management, daily physical activity, sleep and depression scores in patients with COPD, according to new data published in Annals of the American Thoracic Society.

“We found that remote patient monitoring with health coaching produces a significant and clinically meaningful improvement in the disease-specific physical and emotional quality of life in moderate to severe COPD patients,” Roberto P. Benzo, MD, MS, founding director in the division of pulmonary, critical care and sleep medicine at the Mindful Breathing Laboratory at Mayo Clinic in Rochester, Minnesota, and colleagues wrote. “This study is the first study of remote patient monitoring in COPD that improves quality of life: three previous remote patient monitoring studies have been ineffective in improving quality of life [and] health care utilization.”



Source: Adobe Stock.

Source: Adobe Stock.

The multicenter clinical trial included 375 adults with COPD (mean age, 69 years; 59% women). All patients were randomly assigned to 12-week remote patient monitoring with health coaching (n = 188) or wait-list usual care (n = 187). The 12-week group had weekly health coaching calls and a remote monitoring system that included a computer tablet, an activity monitor to wear at all times and an oximeter used during daily exercise. The usual care group received an educational packet of 12 self-management themes for weekly self-study.

The primary outcomes were physical and emotional quality of life measured by the Chronic Respiratory Disease Questionnaire (CRQ) summary score.

Researchers reported a clinically meaningful difference at 12 weeks in physical (difference = 0.54 points; P < .001) and emotional (difference = 0.51 points; P < .001) CRQ summary scores between patients in the intervention group compared with the control group.

Secondary outcomes of domains including self-management, daily physical activity, sleep and depression scores all also improved in patients in the intervention group compared with the control group (P < .01 for all).

These changes maintained at 24 weeks.

“[R]emote patient monitoring with health coaching represents a sustainable alternative for individuals that cannot attend conventional pulmonary rehabilitation or prefer a home intervention focused on lifestyle and behavior change,” the researchers wrote. “Health coaching with lifestyle monitoring aimed to promote wellness, defined by the WHO has an active process of becoming aware of and making choices towards a fulfilling life and a state of balance and not merely the absence of disease.”

Source link

Primary care clinicians often struggle to care for their patients with chronic obstructive pulmonary disease (COPD), thanks to a lack of real-world evidence as to which treatments work best.

As a result, potentially preventable life-threatening exacerbations are common among people with the condition. Central to the problem, some experts believe, is that the average patient bears little resemblance to participants in clinical trials of the medications used to treat COPD.

Indeed, a recent study showed that many COPD patients who were receiving maintenance therapy that should have been controlling their disease experienced severe flare-ups ― a finding that caught the researchers by surprise.

"We know the benefit of COPD treatments in the context of clinical trials. However, the kinds of patients in primary care may not completely mimic those in clinical trials," one of the authors, MeiLan Han, MD, a professor of medicine in the Division of Pulmonary and Critical Care at the University of Michigan, Ann Arbor, told Medscape Medical News. Han, a volunteer medical spokesperson for the American Lung Association, added that patients "may not be as adherent to medications in real life as they are in clinical trials."

Randomized controlled trials that support regulatory drug approvals typically enroll patients who do not have comorbid conditions, who are younger than the average patient with COPD, and who typically are male. Patients are seen in resource-abundant settings designed to maximize adherence to treatment, with supports such as free medication and frequent monitoring ― settings far different from those in which most primary care physicians practice.

The authors of the new article said trials conducted with typical patients in primary care settings could help physicians to optimize treatment.



Dr Barbara Yawn

Real-world evidence can shed light on physicians' intent and on barriers to following guidelines, as well as important patient factors, such as adherence and good inhaler technique, Barbara Yawn, MD, an adjunct professor in the Department of Family and Community Health at the University of Minnesota, Minneapolis, and a co-author of the study, told Medscape Medical News.

A Window Onto Patient Burden

According to the Centers for Disease Control and Prevention, an estimated $15 million Americans have COPD. Annual costs to the healthcare system approach $50 billion a year. The death rate for COPD has increased since 1969 as death rates of other major killers in the United States, such as heart disease and cancer, declined, according to a 2015 analysis of death records.

The new study, published in the July/August issue of the Annals of Family Medicine, provides a snapshot of COPD's toll on patients.

Researchers examined electronic health records of 17,192 patients treated at primary care clinics in five states using a dataset maintained by DARTNet Institute, a nonprofit organization that supports research and quality improvement. They also analyzed self-reported assessments from 1354 patients in the dataset who are in a registry called Advancing the Patient Experience in COPD.

Over half (56%) of patients were female, White (64%), aged 55 to 84 years (81%), and current or ex-smokers (80%). The vast majority had three or more comorbidities, including hypertension, diabetes, and depression.

Serious flare-ups were common; 38% of patients had experienced one or more exacerbations in the previous year. Of registry respondents, half said they had had at least one exacerbation, and 20% said they had been hospitalized for COPD during that period.

Among patients in the registry, 43% reported that COPD had a high or very high impact on their health, and 45% could not walk at a normal pace without losing their breath.

Almost 90% of patients were receiving a maintenance therapy regimen. The number of exacerbations was "somewhat surprising," the authors say. They write that the findings may indicate that patients were not receiving appropriate treatment or were not complying with their medication regimens and that there may be a need for nonpharmacologic interventions, such as smoking cessation. They also write that physician education is needed to support earlier diagnosis and treatment so as to delay declines in lung function.

The researchers say their findings highlight "the need for more real-life effectiveness trials to better support decision making at the primary care level."

Yawn is a co-investigator of one such study, called CAPTURE, which is assessing a screening tool for COPD in primary care practices.



Dr Jerry Krishnan

At the University of Illinois Chicago, Jerry Krishnan, MD, PhD, pulmonologist and professor of medicine and public health, is running the RELIANCE study, which is comparing the use of azithromycin and roflumilast in preventing hospitalization and death among patients with COPD who continue to have exacerbations.

Although RELIANCE involves pulmonologists, Krishnan told Medscape it offers a model for building real-world evidence on questions relevant to primary care. "We don't really know if medications used by patients in my clinic are as effective as reported in clinical trials that were used to obtain regulatory approvals by the US Food and Drug Administration," he said.

Wilson Pace, MD, a family physician and chief medical officer and chief technology officer of DARTNet, said funders of research are becoming aware of the need for real-world studies along with "gold standard" efficacy trials.

Pace, who helped conduct the new study, said a remaining obstacle to improving care is "a defeatist attitude of clinicians" who are skeptical about the ability of therapy to have an effect.

Real-world evidence could remedy clinician frustrations, he said. When clinicians are shown that they can improve patients' quality of life and maybe even reduce the cost of care, "then they will hopefully pay attention," he said.

Some experts who were not involved in the study said the findings offer an illuminating, although incomplete, picture. Nonpharmacologic interventions, the management of other health problems, and access to specialty care are not addressed, and the researchers didn't have data on treatment adherence, inhaler technique, and patients' peak inspiratory flow ― factors that influence the effectiveness of medications. The study also lacked information on whether patients received pulmonary rehabilitation to help their heart and lungs work better.

Nicola Hanania, MD, a professor of medicine and director of the Airways Clinical Research Center at Baylor College of Medicine, Houston, Texas, said the study "adds a lot to what we have known" but pointed out that COPD is grossly underdiagnosed.

According to one analysis of National Health and Nutrition Examination Surveys, 72% of individuals with COPD don't know they have the condition. Such patients were not included in the study, Hanania noted.

"We need pragmatic studies over multiple years to better understand" the condition, Yawn said. Real-world evidence "based in an academic setting or specialty practices is not sufficient," she added. "We need to see results from patients and clinics that look like what we have."

The registry was established and funded by Optimum Patient Care Global, a nonprofit organization, and Boehringer Ingelheim. Han has consulted for Boehringer Ingelheim, GlaxoSmithKline, and AstraZeneca and has received research support from Novartis and Sunovion. Yawn has served on advisory boards for GlaxoSmithKline, Astra- Zeneca, Novartis, and Boehringer Ingelheim and has received research funds from GlaxoSmithKline, Boehringer Ingelheim, AstraZeneca, and Novartis. Krishnan has disclosed no relevant financial relationshps. Hanania has received honoraria for serving as consultant or advisory board member for GSK, Boehringer Ingelheim, Novartis, Sanofi, AstraZeneca, Teva, Genentech, and Amgen. His institution has received research grant support on his behalf from GSK, Sanofi, Boehringer Ingelheim, AstraZeneca, Genentech, Teva, and Novartis. Pace is on the advisory board for Mylan and has received stock from Novo Nordisk, Pfizer, Novartis, Johnson & Johnson, Stryker, Amgen, Gilead, and Sanofi.

Ann Fam Med. 2022;20:319-327. Full text

Mary Chris Jaklevic is a healthcare journalist in the Midwest.

For more news, follow Medscape on Facebook, Twitter, Instagram, and YouTube.



Source link




07.08.2022 12:08

Learning to breathe independently again with electronic "personal trainer"


Greifswald University Medical Center will continue to rely on a new medical technology development from Canada for respiratory patients in the future

The Department of Internal Medicine B at Greifswald University Medical Center has been participating in an international multicenter study (RESCUE 3*) for two years, in which a special diaphragm stimulation therapy is used to wean patients on artificial respiration (see idw-online.de/de/news750754).

Now, the latest generation of the enhanced AeroPace™ neurostimulation system has been introduced in Greifswald and can be used immediately for suitable ventilation patients in Greifswald.

The innovative system, which aims to achieve faster independence from the ventilator, is currently only available in Germany as part of studies. Worldwide, the examination data of 175 ventilator patients have been recorded and evaluated in the RESCUE-3 study so far, 35 of them from Greifswald. Greifswald University Medical Center is thus the leading study center worldwide for the new procedure.
"We have been able to gain extensive experience with electrostimulation of the diaphragm at Unimedicine," emphasized Prof. Dr. Ralf Ewert, head of the Pneumology, Infectious Diseases and Weaning Center at Greifswald University Medical Center. "As a result of the corona pandemic, we have many more men and women who require intensive care and are temporarily dependent on artificial ventilation. In the overall spectrum of efforts to wean patients off long-term ventilation, this method is increasingly taking a firm place. From the perspective of our treatment team, the results to date are promising. It is also very gratifying that the system has been fundamentally refined and made more practical within a short period of time."
Flaccid diaphragm reactivates Diaphragmatic dysfunction is commonly observed when weaning from invasive mechanical ventilation. Ventilators use positive pressure to force air into the lungs so that the main breathing muscle, the diaphragm, is not stressed. Especially with prolonged ventilation, the diaphragm, a plate of muscles and tendons between the chest and abdomen, loses strength and functionality. There is a risk of a so-called ventilation-induced diaphragmatic dysfunction. This is where the procedure from Canada comes in, which has been undergoing intensive testing worldwide for two years. The diaphragm and the phrenic nerves are stimulated via a catheter to restore diaphragm strength and enable natural, independent breathing.
Page 2

What can the new system do?

Meanwhile, the entire mobile console with the control unit has been optimized, significantly shortening the preparation for therapy. There is now an almost automated process in the treatment with electrostimulation. The catheter can be placed by means of a connected ECG, which can be used during catheter insertion or immediately thereafter.. Whereas previously the catheter could "only" stimulate the diaphragm, it is now also suitable for infusing drugs and fluids in intensive care patients. The technically modified electrodes on the catheter provide a better coupling to the phrenic nerves. The AeroPace neurostimulation console sends a signal to the electrodes on the AeroPace catheter to stimulate the phrenic nerve. Like a personal trainer, the exercise intensity can be adjusted to provide repetitive exercises for the diaphragm muscle, depending on the individual's situation.
"We will certainly continue to bring this method to bear outside of the ongoing clinical trial, as we are convinced of its effectiveness. In our experience, electrostimulation of the diaphragm is a useful addition to the extensive efforts to wean patients off long-term ventilation," the pulmonologist said. "The goal is to significantly reduce artificial ventilation time."

*Background RESCUE-3 Study
Launched in 2019, the RESCUE-3 study is a randomized, controlled, open-label, multicenter adaptive clinical trial to evaluate the safe and effective performance of the Lungpacer Membrane Stimulation Therapy System in patients who cannot be weaned from mechanical ventilation. Patients have failed two or more weaning attempts and required more than 96 hours (4 days) of mechanical ventilation. The study will enroll up to 400 subjects and will be conducted at up to 80 sites in the U.S. and EU.

Results from an earlier Lungpacer clinical trial published in the February issue of this year's American Journal of Respiratory Critical Care Medicine (www.atsjournals.org/doi/full/10.1164/rccm.202107-1709OC) showed that Lungpacer therapy strengthened the diaphragm by 246 percent more and improved lung function by 128 percent more than in patients who did not receive the therapy. It also shortened weaning time by 1.4 days and extended survival by 7.9 percent. For more information, visit www.lungpacer.com

Greifswald University Medical Center
Clinic and Polyclinic for Internal Medicine B
Director: Prof. Dr. med. Stephan Felix
Head of study: Prof. Dr. Ralf Ewert
E [email protected]
T +49 3834 86-80 595

Head of Communications and Marketing Press
Spokesperson: Christian Arns T +49 3834 86-52 28
E [email protected]
www.medizin.uni-greifswald.de
www.facebook.com/UnimedizinGreifswald
Instagram/Twitter @UMGreifswald


Wissenschaftliche Ansprechpartner:

Head of study: Prof. Dr. Ralf Ewert
E [email protected]
T +49 3834 86-80 595


Merkmale dieser Pressemitteilung:

Journalisten, Wissenschaftler
Biologie, Elektrotechnik, Medizin
überregional
Forschungsprojekte
Englisch


Source link

August 03, 2022

2 min read


Disclosures:
Cameron reports no relevant financial disclosures. Please see the study for all other authors’ relevant financial disclosures.


We were unable to process your request. Please try again later. If you continue to have this issue please contact [email protected].

Findings published in Chest highlighted the importance of routinely capturing treatment burden among individuals with cystic fibrosis in clinical trials.

“The recent introduction of CFTR modulator therapies is transforming the outcomes and prognosis for many people with cystic fibrosis, with evidence emerging that their introduction is associated with reduced use of other treatments,” Rory A. Cameron, PhD, MScPH, research scientist at Norwich Medical School at the University of East Anglia, England, and colleagues wrote. “To date, however, these innovations have been designed to be additive to existing regimens, so reduction of burden of treatment remains a priority.”



Cystic Fibrosis

Source: Adobe Stock.

Researchers conducted an online discrete choice experiment among 103 adults with cystic fibrosis (mean age, 35 years; 52% women) who attended a specialist cystic fibrosis center. The experiment required all participants to evaluate hypothetical cystic fibrosis treatment profiles, defined by lung function impact, pulmonary exacerbations, abdominal symptoms, life expectancy, quality of life, use of inhaled medications and physiotherapy requirement.

The response rate for all participants was 37%. Overall, researchers observed that an average life expectancy improvement of 10 years or more resulted in the greatest impact on treatment preference, followed by a lung function increase of 15%. Individuals reported wanting to trade substantial reductions in such key outcomes to reduce their treatment time or burden.

The largest trade-offs were for quality of life improvement, with participants willing to accept a 8.2% predicted FEV1 reduction or 4.2 years of additional life expectancy.

Across this sample of individuals with cystic fibrosis, researchers identified three distinct subgroups that each placed substantially different importance on life expectancy and lung function compared with other attributes. In addition, participants were also willing to accept lung function or additional life expectancy reductions to reduce their treatment burden with:

  • 6.1% predicted FEV1 reduction or 3.2 years of additional life expectancy to fully stop physiotherapy;
  • 5.3% predicted FEV1 reduction or 2.7 years of additional life expectancy if abdominal symptoms improved with reductions in pancreatic enzyme replacement therapy; and
  • 4.4% predicted FEV1 reduction or 2.3 years of additional life expectancy to cut time spent on inhaled medications in half.

“The study provides important evidence on the relative importance of outcomes from a patient perspective that could be used alongside other scientific evidence in health technology appraisals to support decision-making for either the regulation or funding of cystic fibrosis treatments,” the researchers wrote. “Moreover, the comparative importance of treatment burden for patients suggests it should be considered as an important secondary outcome in cystic fibrosis when designing future prospective trails of novel therapies.”

Source link

Smoking is the main reason for the development of lung cancer (iStock)

Lung cancer is the most common form of cancer worldwide and the leading cause of death from oncological diseases., Globally about 2.2 million new cases are diagnosed each year and 1.8 million die from this cause. This is a pathology that can be located in the lung tissue itself, inside the bronchi, or both.

In Argentina, approximately 12,000 cases of lung cancer are diagnosed each year, representing 9.3% of all cancers., ranks first as a cause of death from oncological diseases. To raise awareness about the disease, each August 1 remembers world day against lung cancer,

Argentine Association of Respiratory Medicine (AAMR) warned about a worrying fact: Barely 20% of patients are diagnosed in the early stages, when the chances of cure increase to 90%depending on the progression of the pathology, Most are diagnosed Advanced stage, when the chance of successful treatment drops to 10%.

Too, Nine out of every 10 people who suffer from it are smokers, so quitting smoking is always the main objective of all initiatives that try to stop it.

There are many treatments for the different stages of lung cancer, so the diagnosis should not be viewed as the end of life.
There are many treatments for the different stages of lung cancer, so the diagnosis should not be viewed as the end of life.

“In comparison to non-smokers, loss of smokers The risk of lung cancer increases 20-fold, On the other hand, it is possible that many of the affected patients may have lived with smokers for many years of their lives, having been exposed to tobacco similarly to active smokers. In other words, passive smokers (who share an environment with active smokers) have a higher risk of developing lung cancer than someone who has never smoked,” Dr. Karina Patan, Thoracic Surgeon and AAMR. Coordinator of the Oncology Section of and head of the surgical clinical department Respiratory Rehabilitation Hospital Maria Ferre,

With an aim to reverse this scenario and address the problem of late diagnosis, they have been developed globally. Screening program using low-dose radiation chest CT scan in a high-risk populationDefined by age and smoking history.

Investment in the implementation of lung cancer screening programs, which have been reported to increase early-stage prognosis and thus improve survival in clinical trials conducted in the United States and Europe , it can also reduce health system costs.

Lung cancer is a malignant disease that can be located in the lung tissue itself, inside the bronchi, or both (Getty).
Lung cancer is a malignant disease that can be located in the lung tissue itself, inside the bronchi, or both (Getty).

In what sense, Argentine Association of Respiratory Medicine highlighted that In addition to the invaluable cost of saving patients’ lives, early diagnosis reduces the strain on the health system.Coverage cost increases according to the stage of the disease. “It is estimated that the cost of treating one patient in stage IV is equivalent to 10 stage I treatments,” the unit exemplified.

While it is necessary to highlight that the majority of lung cancer cases are related to tobacco, the focus of discussion today is on how to implement early detection programs so that they are sustainable over time, targeted without creating disparity. How to select populations and reduce the risks inherent in interventions.

“We are in the process of publication from the Argentine Association of Respiratory Medicine An inter-social Argentine consensus on screening that includes all the specialties working on the topicAnd we’ve developed a collaborative registry of institutions that are already working with screening programs,” explains Dr. iris boyeras (MN 118.839), Pulmonologist and member of the Oncology Section of the Argentine Association of Respiratory Medicine.

It aims to ensure that, just as control mammograms are performed annually, leading to early breast cancer diagnosis, in the future, tomographic screening programs can be implemented for early detection of lung cancer.

read on:

Lung cancer: the most appropriate treatment for each stage of the disease

Lung cancer: With new treatments, they want to make it a chronic disease

Closer to personalized treatment: A computer algorithm detected cancer subtypes



Source link

A large campaign in Uganda to ramp up HIV testing and immediate HIV treatment reduced the incidence of tuberculosis in the intervention communities by 27% after one year, underlining the potential impact of HIV-related investments on wider population health, investigators of the SEARCH study reported at AIDS 2022 on Sunday.

The SEARCH study is one of the largest implementation studies of universal HIV test-and-treat to be conducted. The study randomised communities to receive either the intervention or standard of care according to national guidelines and took place between 2013 and 2016 in rural communities in Uganda and Kenya. The intervention consisted of:

  • A multi-disease prevention campaign that included testing for HIV, diabetes and hypertension, with a two-week health fair and household testing in each community.
  • Linkage to care of anyone who tested positive
  • Immediate antiretroviral therapy (ART), regardless of CD4 count

Results from the SEARCH study have been presented at several major conferences and demonstrate substantial impact of the intervention, including:

Glossary

active TB

Active disease caused by Mycobacterium tuberculosis, as evidenced by a confirmatory culture, or, in the absence of culture, suggestive clinical symptoms.

linkage to care

Refers to an individual’s entry into specialist HIV care after being diagnosed with HIV. 

p-value

The result of a statistical test which tells us whether the results of a study are likely to be due to chance and would not be confirmed if the study was repeated. All p-values are between 0 and 1; the most reliable studies have p-values very close to 0. A p-value of 0.001 means that there is a 1 in 1000 probability that the results are due to chance and do not reflect a real difference. A p-value of 0.05 means there is a 1 in 20 probability that the results are due to chance. When a p-value is 0.05 or below, the result is considered to be ‘statistically significant’. Confidence intervals give similar information to p-values but are easier to interpret. 

test and treat

A public health strategy in which widespread HIV testing is facilitated and immediate treatment for those diagnosed with HIV is encouraged.

standard of care

Treatment that experts agree is appropriate, accepted, and widely used for a given disease or condition. In a clinical trial, one group may receive the experimental intervention and another group may receive the standard of care.

At AIDS 2022, Dr Carina Marquez of the University of California San Francisco presented results of an analysis of TB incidence in nine communities that participated in the SEARCH study in Uganda, where TB symptom screening was a component of the intervention.

The study sampled 100 households that included at least one person with HIV and 100 households without a person with HIV in each community. Tuberculin skin tests were carried out on each household member over the age of 5 at baseline and one year later.

The study measured the incidence of TB after one year by looking at conversion from negative to positive tuberculin skin test, indicating likely recent exposure to TB in the community.

The study sampled 1435 households in nine communities, testing 4,884 people at baseline (58% of those eligible to participate). Those tested were predominantly under 18 (58% in the intervention communities), 46% lived in a household with a person with HIV, 10% were living with HIV and over 90% had received the BCG vaccination to protect against TB.

Twenty-two percent tested positive at baseline, leaving 3,381 people in the TST-negative cohort at baseline. One year later, 78% of the TST-negative cohort were available for re-testing.

After one year, the incidence of TB was 27% lower in intervention communities. Sixteen percent of participants in intervention communities tested positive for TB after one year compared to 22% in control group communities. The reduction in risk was significant in children aged 5-11 years (aRR 0.71, 95% CI 0.52-0.97, p=0.016) but not in participants aged 12 and over (aRR 0.84, 95% CI 0.64-1.11, p=0.106). This result is probably explained by the fact that adolescents and adults were more likely to have been exposed to TB previously, Carina Marquez said.

She told the conference that reduced TB incidence is likely to be a consequence of several factors. As well as a reduction in the duration of infectiousness due to improved detection and treatment of active TB through symptom screening, susceptibility to the activation of latent TB or progression to active TB is likely to be reduced due to improved immune status in people on antiretroviral treatment. This leads to a reduction in the number of people with active TB in the community.

Source link

FOUND EFFECTIVE FOR TREATING COVID-19

Oxford University’s RECOVERY clinical trial has found that low-dose dexamethasone increases the chance of survival in patients with COVID-19 who require respiratory support.

In the study, the drug reduced the number of deaths by one-third for people on ventilators, and by one-fifth for people on oxygen. There was no benefit found for people who didn’t require respiratory support. Do not use this medication to treat COVID-19 unless your doctor recommends that you do so. If you have questions about the use of dexamethasone for COVID-19, talk with your doctor.

For information on how to prepare, advice on prevention and treatment, and expert recommendations, visit our COVID-19 hub.

  1. Dexamethasone oral tablet is available as both a generic and brand-name drug. Brand name: DexPak.
  2. Dexamethasone comes as an oral tablet, oral solution, eye drops, and ear drops. It’s also available as an injectable solution or an intraocular solution given after surgery. These two forms are given only by a healthcare provider.
  3. Dexamethasone oral tablet is used to treat many conditions. These include inflammation, allergic reactions, and flare-ups of ulcerative colitis. They also include adrenal insufficiency.

  • Allergic reaction: Dexamethasone may cause an allergic reaction in rare cases. If you have trouble breathing, a rash, or itchy skin, or notice swelling of your arms, feet, or tongue, call your doctor immediately. Call 911 if your symptoms feel life threatening or if you think you’re having a medical emergency.
  • Heart damage: If you’ve recently had a heart attack, you may be at increased risk for further heart damage from this drug. Before starting this drug, be sure your doctor knows you’ve had a heart attack.
  • Infection: Dexamethasone can cover up or worsen certain infections. In addition, infections can develop during treatment. Don’t use this drug if you have fungal infections, or a history of parasite infections or tuberculosis. Tell your doctor about any past illnesses or infections.
  • Eye problems: Using dexamethasone for long periods can lead to eye problems such as cataracts or glaucoma. The drug may also cause damage to the optic nerves, or fungal or viral eye infections.
  • Measles or chickenpox: Tell your doctor if you haven’t had chickenpox or measles, or if you haven’t had the vaccines to prevent them. You could have more serious versions of these illnesses if you have them while taking dexamethasone.

Dexamethasone is a prescription medication. It’s available as an oral tablet, oral solution, eye drops, and ear drops. It’s also available as an injectable solution or an intraocular solution given after surgery. These last two forms are given only by a healthcare provider.

The dexamethasone tablet is available as the brand-name drug DexPak. It’s also available as a generic drug. Generic drugs usually cost less than the brand-name version. In some cases, they may not be available in all strengths or forms as the brand-name drug.

Why it’s used

The dexamethasone oral tablet is used to treat conditions that cause inflammation, conditions related to immune system activity, and hormone deficiency. These conditions include:

How it works

Dexamethasone belongs to a class of drugs called steroids. A class of drugs is a group of medications that work in a similar way. These drugs are often used to treat similar conditions.

  • For conditions with inflammation: With certain conditions, inflammation can cause the immune system to be overactive. This can damage the body’s tissues. Steroids such as dexamethasone help block the immune system’s response to inflammation, which helps prevent this damage.
  • For adrenal insufficiency: The adrenal gland helps control certain body functions. These functions include managing blood glucose, fighting infection, and controlling stress. In people with adrenal insufficiency, the adrenal gland releases lower amounts of certain hormones. Dexamethasone helps replace these hormones.

Dexamethasone oral tablet doesn’t cause drowsiness, but it can cause other side effects.

More common side effects

The more common side effects that can occur with dexamethasone oral tablets include:

  • nausea
  • vomiting
  • stomach upset
  • swelling (edema)
  • headache
  • dizziness
  • mood changes, such as depression, shifts in mood, or personality changes
  • trouble falling asleep
  • anxiety
  • low potassium levels (causing symptoms such as tiredness)
  • high blood glucose
  • high blood pressure

If these effects are mild, they may go away within a few days or a couple of weeks. If they’re more severe or don’t go away, talk to your doctor or pharmacist.

Serious side effects

Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life threatening or if you think you’re having a medical emergency. Serious side effects and their symptoms can include the following:

  • Unusual tiredness
  • Unusual dizziness
  • Unusual digestive upset. Symptoms can include:
    • stomach pain
    • nausea or vomiting
  • Blood in your stool, or black stools
  • Blood in your urine
  • Unusual bleeding or bruising
  • Unusual swelling throughout your body, or bloating in your abdomen (stomach area)
  • Infection. Symptoms can include:
    • fever
    • muscle aches
    • joint pain
  • Changes in mood or thoughts, or mood disorders such as depression. Symptoms can include:
    • severe mood shifts
    • euphoria (a feeling of intense happiness)
    • trouble sleeping
    • personality changes
  • Severe allergic reaction. Symptoms can include:
  • Adrenal insufficiency. Symptoms can include:
    • tiredness
    • nausea
    • darkened skin color
    • dizziness when standing
  • More frequent infections (can occur with long-term use)
  • Stomach ulcers. Symptoms can include:
    • pain in the abdomen (stomach area)
  • Congestive heart failure. Symptoms can include:
    • shortness of breath
    • tiredness
    • swollen legs
    • rapid heartbeat
  • Osteoporosis (thinning of the bones)

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this information includes all possible side effects. This information is not a substitute for medical advice. Always discuss possible side effects with a healthcare provider who knows your medical history.

Dexamethasone oral tablet can interact with other medications, vitamins, or herbs you may be taking. An interaction is when a substance changes the way a drug works. This can be harmful or prevent the drug from working well.

To help avoid interactions, your doctor should manage all of your medications carefully. Be sure to tell your doctor about all medications, vitamins, or herbs you’re taking. To find out how this drug might interact with something else you’re taking, talk to your doctor or pharmacist.

Examples of drugs that can cause interactions with dexamethasone are listed below.

Antibiotics

Erythromycin is used to treat infections caused by bacteria. When used with dexamethasone, this drug can increase the amount of dexamethasone in your body. This raises your risk of side effects.

Antifungal drugs

When used with dexamethasone, certain drugs used to treat fungal infections can increase the level of dexamethasone in your blood. This can raise your risk of side effects. Examples of these drugs include:

  • ketoconazole
  • itraconazole
  • posaconazole
  • voriconazole

Amphotericin B is another drug used to treat fungal infections. Using this drug with dexamethasone raises your risk of low potassium levels. (Potassium is a mineral that helps your nerves, muscles, and organs work normally.) This can cause muscle cramps, weakness, tiredness, and an irregular heartbeat.

Blood thinners

Using dexamethasone with certain blood thinners can decrease the levels of these drugs in your body. This can make them less effective, and raise your risk of clots or stroke. Examples of these drugs include:

Warfarin is also used to thin the blood. Using dexamethasone with this drug may result in changes to your risk of bleeding. Your doctor may need to monitor you closely.

Cholesterol drugs

If you take dexamethasone with certain drugs used to lower cholesterol, it can keep your body from absorbing dexamethasone well. This could keep dexamethasone from working well. Examples of these drugs include:

  • cholestyramine
  • colesevelam
  • colestipol

Cushing’s syndrome drugs

Aminoglutethimide is used to treat symptoms of Cushing’s syndrome (a disease of the adrenal gland). Using this drug with dexamethasone may decrease the amount of dexamethasone in your body. This means it may not work as well.

Diabetes drugs

Dexamethasone may increase your blood glucose. If you take diabetes drugs, your doctor may need to change your dose. Examples of these drugs include:

  • amylin analogs, such as:
  • biguanides, such as:
  • GLP-1 agonists, such as:
    • exenatide
    • liraglutide
    • lixisenatide
  • DPP4 inhibitors, such as:
    • saxagliptin
    • sitagliptin
    • insulin
  • meglitinides, such as:
  • sulfonylureas, such as:
    • glimepiride
    • glipizide
    • glyburide
  • SGLT-2 inhibitors, such as:
    • canagliflozin
    • dapagliflozin
    • empagliflozin
  • thiazolidinediones, such as:
    • pioglitazone
    • rosiglitazone

Diuretics (water pills)

When used with dexamethasone, these drugs reduce your body’s potassium levels. (Potassium is a mineral that helps your nerves, muscles, and organs work normally.) This can cause muscle cramps, weakness, tiredness, and an irregular heartbeat. Examples of these drugs include:

  • bumetanide
  • furosemide
  • hydrochlorothiazide

Epilepsy drugs

When used with dexamethasone, certain drugs used to treat epilepsy can lower the level of dexamethasone in your blood. This can keep dexamethasone from working well. Examples of these drugs include:

  • phenytoin
  • fosphenytoin
  • phenobarbital
  • carbamazepine

Heart drugs

Digoxin is used to treat heart rhythm problems or heart failure. Taking this drug with dexamethasone could increase your risk of irregular heartbeats caused by low potassium levels. (Potassium is a mineral that helps your nerves, muscles, and organs work normally.)

Hormones

Taking certain hormones with dexamethasone can cause decreased levels of these hormones in your body. Your doctor may have to adjust your dose of either the dexamethasone or hormone medications. Examples of these drugs include:

  • estrogens
  • oral contraceptives

HIV drugs

Taking certain drugs used to treat HIV with dexamethasone can reduce the levels of these drugs in your body. This means they may not work as well, and your body may stop responding to your HIV medications. Your doctor may avoid use of these drugs with dexamethasone. Examples of these drugs include:

  • protease inhibitors, such as:
    • atazanavir
    • darunavir
    • fosamprenavir
    • indinavir
    • nelfinavir
    • ritonavir
    • saquinavir
    • simeprevir
    • tipranavir
  • non-nucleoside reverse transcriptase inhibitors, such as:
  • entry inhibitors, such as:
  • integrase inhibitors, such as:

NSAIDs

Using nonsteroidal anti-inflammatory drugs (NSAIDs) with dexamethasone raises your risk of stomach upset. Talk with your doctor about whether you can take these drugs together. Examples of NSAIDs include:

  • aspirin
  • ibuprofen
  • indomethacin
  • naproxen

Tuberculosis drugs

When used with dexamethasone, certain drugs used to treat tuberculosis (TB) can lower the level of dexamethasone in your blood. This can keep dexamethasone from working well. Examples of these drugs include:

  • rifampin
  • rifabutin
  • rifapentine

Isoniazid is another TB drug. When it’s used with dexamethasone, levels of isoniazid can be lowered. This can keep isoniazid from working well.

Vaccines

Avoid getting live vaccines when taking dexamethasone. With live vaccines, you’re injected with a small amount of a virus so your body can learn to fight it.

You shouldn’t get these vaccines while using dexamethasone because the drug weakens your immune system. If this happens, your body won’t be able to properly fight the vaccine, and it may make you sick.

Live vaccines you should avoid while taking dexamethasone include:

Other drugs

Aspirin is a nonsteroidal anti-inflammatory drug (NSAID). It’s often used to treat pain, as well as thin the blood to reduce your risk of heart attack. Dexamethasone can decrease your aspirin levels. This can make aspirin less effective and increase your risk of heart attack. Also, aspirin can increase your risk of bleeding from stomach ulceration (sores) when used with dexamethasone. If you take aspirin, talk with your doctor about whether dexamethasone is safe for you.

Thalidomide is used to treat skin lesions and multiple myeloma. Combining it with dexamethasone can cause toxic epidermal necrolysis. This skin condition can be life threatening. If your doctor prescribes both of these drugs for you, they will be cautious about effects the combination can cause.

Cyclosporine is used to prevent organ rejection in transplant patients, as well as to treat rheumatoid arthritis or psoriasis. Taking this drug with dexamethasone could increase the risk that your immune system will be suppressed (won’t work well). This would raise your risk of infection. Seizures have also been reported when these drugs are used together.

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs interact differently in each person, we cannot guarantee that this information includes all possible interactions. This information is not a substitute for medical advice. Always speak with your healthcare provider about possible interactions with all prescription drugs, vitamins, herbs and supplements, and over-the-counter drugs that you are taking.

This drug comes with several warnings.

Allergies

Dexamethasone can cause a severe allergic reaction. Symptoms can include:

  • trouble breathing
  • swelling of your throat or tongue

If you have an allergic reaction, call your doctor or local poison control center right away. If your symptoms are severe, call 911 or go to the nearest emergency room.

Don’t take this drug again if you’ve ever had an allergic reaction to it. Taking it again could be fatal (cause death).

For people with certain health conditions

For people with infections: Dexamethasone may make a systemic fungal infection worse. (Systemic means it affects the whole body, not just one part.) This drug shouldn’t be used if you’re taking medication to treat a systemic fungal infection. Also, dexamethasone may hide the signs of a non-fungal infection.

For people with congestive heart failure: Dexamethasone can increase sodium levels, edema (swelling), and potassium loss. This can make your heart failure worse. Before taking this drug, talk to your doctor about whether it’s safe for you.

For people with high blood pressure: Dexamethasone can increase sodium levels and edema (swelling). This can increase your blood pressure. Before taking this drug, talk to your doctor about whether it’s safe for you.

For people with peptic ulcers: Dexamethasone can increase the risk of stomach or intestinal bleeding and ulcers. If you have peptic ulcers or other conditions of the intestines, talk to your doctor about whether this drug is safe for you. Conditions of the intestines include:

  • diverticulitis
  • ulcerative colitis

For people with osteoporosis: Dexamethasone decreases bone formation. It also increases bone resorption (breakdown of bone). As a result, it raises the risk of osteoporosis (bone thinning). The risk is higher for people already at an increased risk of osteoporosis. These include postmenopausal women.

For people with hyperthyroidism: This drug is removed from the body more quickly than normal. Your doctor may adjust your dose of this drug based on your condition.

For people with eye problems: Long-term use of dexamethasone may cause eye problems such as cataracts or glaucoma. Your risk is higher if you already have eye problems such as cataracts, glaucoma, or increased pressure in the eye.

For people with tuberculosis: If you have latent tuberculosis or tuberculin reactivity, dexamethasone can reactivate the disease. If you test positive for tuberculosis, talk with your doctor about whether taking this drug is safe for you.

For people with recent history of heart attack: If you’ve recently had a heart attack, use of dexamethasone may lead to a tear in your heart muscle. Before you start this drug, be sure your doctor knows you’ve had a recent heart attack.

For people with diabetes: Dexamethasone can increase blood sugar levels. As a result, your doctor may change the dose of your antidiabetic drugs.

For people with myasthenia gravis (MG): If you have MG, using dexamethasone with certain drugs used to treat Alzheimer’s disease can cause severe weakness. Examples of these drugs include memantine, rivastigmine, and donepezil. If possible, wait at least 24 hours after taking these drugs to start dexamethasone therapy.

For pregnant women

Dexamethasone is a category C pregnancy drug. That means two things:

  1. Research in animals has shown adverse effects to the fetus when the mother takes the drug.
  2. There haven’t been enough studies done in humans to be certain how the drug might affect the fetus.

Talk to your doctor if you’re pregnant or planning to become pregnant. This drug should only be used if the potential benefit justifies the potential risk to the fetus.

For women who are breastfeeding

Dexamethasone is not recommended for women who are breastfeeding. The drug can pass to a child through breast milk and may cause side effects.

For seniors

The kidneys and liver of older adults may not work as well as they used to. This can cause your body to process drugs more slowly. As a result, more of a drug stays in your body for a longer time. This raises your risk of side effects.

All possible dosages and forms may not be included here. Your dose, form, and how often you take it will depend on:

  • your age
  • the condition being treated
  • how severe your condition is
  • other medical conditions you have
  • how you react to the first dose

Dosage for inflammation and other conditions

Generic: Dexamethasone

  • Form: oral tablet
  • Strengths: 0.5 mg, 0.75 mg, 1 mg, 1.5 mg, 4 mg, and 6 mg

Brand: DexPak

  • Form: oral tablet
  • Strengths: 0.25 mg, 0.5 mg, 0.75 mg, 1 mg, 1.5 mg, 4 mg, and 6 mg

Adult dosage (ages 18 years and older)

Typical dosage: 0.75–9 mg every day, depending on the condition being treated.

Child dosage (ages 0–17 years)

Initial dosage: 0.02–0.3 mg per kilogram of body weight per day, taken in three or four divided doses. Dosage depends on the condition being treated.

Senior dosage (ages 65 years and older)

The kidneys and liver of older adults may not work as well as they used to. This can cause your body to process drugs more slowly. As a result, more of a drug stays in your body for a longer time. This raises your risk of side effects.

Your doctor may start you on a lowered dose or a different dosing schedule. This can help keep levels of this drug from building up too much in your body.

Special dosage considerations

When stopping treatment, your dosage should be decreased slowly over time. This helps to prevent withdrawal side effects.

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this list includes all possible dosages. This information is not a substitute for medical advice. Always speak with your doctor or pharmacist about dosages that are right for you.

Dexamethasone oral tablets are used for long-term treatment. They come with serious risks if you don’t take them as prescribed.

If you stop taking the drug suddenly or don’t take it at all

If you don’t take the drug at all, your condition won’t be managed. If you stop taking dexamethasone suddenly, you may have withdrawal side effects. These can include:

  • tiredness
  • fever
  • muscle aches
  • joint pain

Your dose should be decreased over time to avoid withdrawal effects. Don’t stop taking dexamethasone unless your doctor tells you to do so.

If you miss doses or don’t take the drug on schedule

Your medication may not work as well or may stop working completely. For this drug to work well, a certain amount needs to be in your body at all times.

If you take too much

You could have dangerous levels of the drug in your body. Symptoms of an overdose of this drug can include:

  • irregular heartbeats
  • seizures
  • severe allergic reaction, with trouble breathing, hives, or swelling of your throat or tongue

If you think you’ve taken too much of this drug, call your doctor or local poison control center. If your symptoms are severe, call 911 or go to the nearest emergency room right away.

What to do if you miss a dose

If you miss a dose, wait and take the next dose as planned. Don’t double your dose. This could result in dangerous side effects.

How to tell if the drug is working

The symptoms of your condition should be reduced.

Keep these considerations in mind if your doctor prescribes dexamethasone for you.

General

  • Take this drug at the time(s) recommended by your doctor.
  • You can cut or crush the tablet.

Storage

  • Keep dexamethasone tablets at room temperature between 68°F and 77°F (20°C and 25°C).
  • Don’t store this medication in moist or damp areas, such as bathrooms.

Refills

A prescription for this medication is refillable. You should not need a new prescription for this medication to be refilled. Your doctor will write the number of refills authorized on your prescription.

Travel

When traveling with your medication:

  • Always carry your medication with you. When flying, never put it into a checked bag. Keep it in your carry-on bag.
  • Don’t worry about airport X-ray machines. They can’t hurt your medication.
  • You may need to show airport staff the pharmacy label for your medication. Always carry the original prescription-labeled box with you.
  • Don’t put this medication in your car’s glove compartment or leave it in the car. Be sure to avoid doing this when the weather is very hot or very cold.

Clinical monitoring

Your doctor will monitor you during treatment with this drug. They may do tests to check for side effects from long-term use of dexamethasone. These tests may include:

  • weight test
  • blood pressure test
  • blood sugar test
  • eye test (glaucoma screening)
  • bone mineral density tests (osteoporosis screening)
  • X-ray of your gastrointestinal tract (this is done if you have symptoms of peptic ulcer, such as severe stomach upset, vomiting, or blood in your stool)

The cost of these tests will depend on your insurance.

There are other drugs available to treat your condition. Some may be better suited for you than others. Talk to your doctor about other drug options that may work for you.

Disclaimer: Healthline has made every effort to make certain that all information is factually correct, comprehensive, and up-to-date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or other healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.

Source link