New research disputes a widely publicized study that linked testosterone replacement therapy with an increased risk of cardiovascular events and all-cause mortality.
More new research disputes a widely publicized study that linked testosterone replacement therapy with an increased risk of cardiovascular events and all-cause mortality. Researchers from the medical schools at Stanford and Baylor analyzed records from 509 men in their institutional databases and found no correlation between testosterone treatment and death from any cause.
Of the 509 men who met inclusion criteria, 284 used testosterone and 225 did not. The mean age in both groups was about 54 and the mean follow-up time was about 10 years. In all, according to the National Death Index, 19 men of the men who did not use testosterone (4.4%) and 9 of the men who did use testosterone (3.2%) died. After adjusting for age and year of evaluation, there was no significant difference in the risk of death based on the use of testosterone therapy (hazard ratio [HR] 0.92, 95% confidence interval [CI] 0.36-2.35, P = 1.0).
The study, which will appear in the International Journal of Impotence Research, is one of several similar works to emerge since the Journal of the American Medical Association published a retrospective analysis of data from the Veteran’s Affairs system.
The JAMA paperâ€‘â€‘which helped convince the US Food and Drug Administration (FDA) to begin an ongoing investigationâ€‘â€‘found significant positive correlation between testosterone replacement and the likelihood of stroke, myocardial infarction (MI) and death.
That conclusion gained partial support a few months later, when PLoS ONE published a paper that correlated testosterone therapy with a dramatically higher risk of heart disease among older patients and younger men with a history of heart disease.
Since then, however, a number of studies have undermined such assertions either by finding no relationship between testosterone replacement and cardiovascular events or by finding evidence that testosterone may protect the heart.
The most striking counter-finding came from an analysis on 19,968 hypogonadal men who received testosterone therapy between 2009 and 2014 at 40 Low T Centers nationwide. That study, which was presented at this year’s meeting of the American Association of Clinical Endocrinologists, found that the testosterone-using men had only about one-seventh the normal risk of MI (HR 0.14, 95% CI 0.098-0.211, P<.0001) and one-ninth the risk of stroke (HR 0.107, 95% CI 0.06-0.21, P<.0001).
Other studies have not found testosterone therapy to have such massive cardiovascular benefits, but many have found evidence of some protective effect.
Earlier this summer, Annals of Pharmacotherapy published an analysis of Medicare records from more 25,000 people. In this case, researchers found no significant overall correlation between testosterone therapy and MI (HR = 0.84; 95% CI = 0.69-1.02). For the quarter of men at the highest risk of MI, however, testosterone therapy was associated with a significantly reduced risk of MI (HR = 0.69; 95% CI = 0.53-0.92).
Such results echo much of what preceded the JAMA study, which has come under attack for numerous mistakes and been corrected twice.
FDA officials will weigh the evidence next month, when its bone, reproductive and urologic drugs advisory committee will hold a joint meeting with its drug safety and risk management advisory committee.