The level of circulating testosterone in patients with COPD does not appear to be predictive of exacerbations, cardiovascular outcomes, or mortality, according to study findings published in BMJ Open Respiratory Research.

Limited research has suggested that individuals with COPD may have low testosterone, which has been associated with reduced muscle mass and cardiovascular risk. Investigators therefore sought to determine whether levels of circulating total testosterone were independently associated with hospitalization for acute exacerbations of COPD (H-AECOPD) and mortality.

The investigators performed separate analyses of data from 2 COPD studies: (1) ECLIPSE (ClinicalTrials.gov Identifier: NCT00292552), a noninterventional, observational, multicenter study to determine underlying mechanisms of COPD progression in patients aged 45 to 75 years in 12 countries; and (2) ERICA, an observational study assessing the role of inflammation in COPD-associated comorbidities in patients with COPD aged 40 years and older in the United Kingdom.

Investigators for the current study analyzed data from 1296 male ECLIPSE participants (mean age, 63.9 years) and 386 male (mean age, 67.9 years) and 244 female participants (mean age, 66.5 years) in ERICA. The participants’ mean (SD) serum testosterone levels were 459 (197) ng/dL for male patients in ECLIPSE and 455 (200) ng/dL for male patients and 28 (56) ng/dL for female patients in ERICA.

Although levels of circulating testosterone are an attractive biomarker, our results do not support the prognostic utility of testosterone testing specifically in patients with COPD.

Univariate and multivariate logistic regression were used to evaluate associations between testosterone levels and outcomes, including occurrence of H-AECOPD and all-cause mortality in both cohorts and a cardiovascular composite outcome of hospitalization and cardiovascular death in ERICA.

Testosterone level was not associated with H-AECOPD in either cohort (ECLIPSE: odds ratio [OR], 0.76; P =.329; ERICA, male participants: OR, 1.06; 95% CI, 0.73-1.56; P =.779, and female participants: OR 0.77; 95% CI, 0.52-1.12; P =.178).

Multivariate analyses revealed no statistically significant associations between circulating testosterone levels and: (1) H-AECOPD rates in male or female patients in ERICA (male patients: OR, 1.17; 95% CI, 0.85-1.72; P =.384; female patients: OR 0.80; 95% CI, 0.52-1.21; P =.299); or (2) H-AECOPD length of stay, cardiovascular hospitalization or death, respiratory-related mortality, or all-cause mortality in ECLIPSE (OR, 0.57, P =.157) or ERICA (male patients: OR, 0.69; 95% CI, 0.48-1.02; P =.055; female patients: OR, 0.64; 95% CI, 0.38-1.04, P =.082).

In multivariate subgroup analyses stratified by GOLD stages (2 and 3/4), testosterone was significantly associated with all-cause mortality in GOLD stage 2 male patients only for both cohorts (OR, 0.25; P =.007 in ECLIPSE and OR, 0.5; 95% CI, 0.32-0.95; P =.030 in ERICA). No significant associations occurred between testosterone and H-AECOPD in the cohorts or in any GOLD stage.

Limitations include the observational design in ECLIPSE and ERICA. Also, menopause status was not recorded, and it is likely that the number of cases of prostate cancer is higher than recorded.

“Although levels of circulating testosterone are an attractive biomarker, our results do not support the prognostic utility of testosterone testing specifically in patients with COPD,” commented the researchers. “The clinical relevance of testosterone’s association with all-cause mortality in GOLD stage 2 male patients with COPD only may reflect its association with mortality observed in elderly men in the general population, an association which is not observed in males with severe to very severe COPD, or females with COPD.”

Disclosure: ECLIPSE was funded by GSK and ERICA by a grant from Innovate UK. Some of the study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.

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