CardioExchange Archive

Trial Raises Concerns Over CV Safety of Testosterone Gel: Shehzad Basaria and colleagues planned to randomize 252 men 65 years or older with limitations in mobility to testosterone gel or placebo for 6 months. The trial was terminated after enrolling 209 subjects after a higher rate of adverse events occurred in the testosterone group. The results are reported in the New England Journal of Medicine. There were 23 cardiovascular adverse events in the testosterone group versus 5 in the placebo group. Men receiving testosterone had significant improvements on several measures of strength.

In their conclusion, the authors state that “caution is warranted in interpreting this finding, because of the small numbers of events and because of limitations with respect to the ascertainment of adverse events. Caution is also warranted in extrapolating these findings to other doses and formulations of testosterone or to other populations, particularly young men who have hypogonadism without cardiovascular disease or limitations in mobility.”

Prasugrel and Cancer: Is There a Link? Two critics of prasugrel have again sought to link the drug to an increased risk of cancer. The paper, by  James Floyd and Victor Serebruany, appears in Archives of Internal Medicine. The cancer data are taken from the detailed FDA analysis of the TRITON-TIMI 38 trial. The authors acknowledge that with the current data it is impossible to demonstrate with certainty an increased risk of cancer, but say that “a safety concern has been raised” and that “physicians should consider the potential cancer risks before prescribing prasugrel, especially with prolonged use and in patients with known cancer.”

In an accompanying editorial, Sanjay Kaul and George Diamond write that although the prasugrel-cancer connection “has not been firmly established, sufficient credible evidence has emerged to raise concerns about a potential risk that arguably adversely alters the benefit-risk profile of its long-term use. Until this issue is resolved, we believe that to optimize the benefit-risk balance, prasugrel use should be limited to a duration of weeks rather than months.”