Miriam E Tucker
March 16, 2015

SAN DIEGO — Two new studies attest to the absence of cardiovascular risk from testosterone-replacement therapy, but, like all of the others, neither is the large, randomized, placebo-controlled trial that experts say would be necessary to answer the safety question once and for all.

In one two-part study involving both a retrospective cohort and nested case-control analysis of a large database of hypogonadal men, no increased risk for venous thrombotic events was seen with testosterone treatment.

In the other study, major adverse cardiovascular events were not increased with testosterone treatment in a retrospective analysis of data from two large, double-blind placebo-controlled efficacy trials of an investigational antiatherosclerotic drug in men with documented coronary disease or recent acute coronary syndrome.
Findings from the two analyses were presented March 7 at ENDO 2015, the annual meeting of the Endocrine Society, by Hu Li, MBBS, PhD, of Eli Lilly, and Salim Janmohamed, MBBS, of GlaxoSmithKline, respectively.

The new data come on the heels of two other studies — one observational, the other a meta-analysis —just presented at the American College of Cardiology (ACC) 2015 Scientific Sessionsthat also showed no increased cardiovascular risk among testosterone users.

All four studies seem to "contradict" the US Food and Drug Administration's warning earlier this month about the current overuse of testosterone-replacement therapy in men who do not have "low T" or in whom levels were not even tested, as well as the potential risks of myocardial infarction (MI) and stroke among men treated with testosterone-replacement therapy.

The FDA began investigating the link between testosterone therapy and adverse cardiovascular outcomes in January 2014 on the basis of two studies that linked the products with increased risks, one in men 65 and older, the other a cohort of Veterans Affairs patients who had multiple comorbidities and were undergoing coronary angiography.

The European Medicines Agency, however, in November 2014 concluded that there is "no consistent evidence" of an increased risk for cardiovascular problems with testosterone products.

Source: http://www.medscape.com/viewarticle/...p&uac=180112PN