{"id":1573,"date":"2010-07-01T15:46:32","date_gmt":"2010-07-01T19:46:32","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/%e2%80%a2trial-raises-concerns-over-cv-safety-of-testosterone-gel%e2%80%a2prasugrel-and-cancer-is-there-a-link\/"},"modified":"2011-07-19T17:44:56","modified_gmt":"2011-07-19T21:44:56","slug":"%e2%80%a2trial-raises-concerns-over-cv-safety-of-testosterone-gel%e2%80%a2prasugrel-and-cancer-is-there-a-link","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2010\/07\/01\/%e2%80%a2trial-raises-concerns-over-cv-safety-of-testosterone-gel%e2%80%a2prasugrel-and-cancer-is-there-a-link\/","title":{"rendered":"\u2022 Trial Raises Concerns Over CV Safety of Testosterone Gel<br \/> \u2022 Prasugrel and Cancer: Is There a Link?"},"content":{"rendered":"<p><strong>Trial Raises Concerns Over CV Safety of Testosterone Gel:<\/strong>&nbsp;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. <a href=\"http:\/\/content.nejm.org\/cgi\/content\/full\/NEJMoa1000485\">The results are reported in the <em>New England Journal of Medicine<\/em>.<\/a> 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.<\/p>\n<p>In their conclusion, the authors state&nbsp;that &#8220;caution is warranted in interpreting this finding, because of&nbsp;the small numbers of events and because of limitations with&nbsp;respect to the ascertainment of adverse events. Caution is also&nbsp;warranted in extrapolating these findings to other doses and&nbsp;formulations of testosterone or to other populations, particularly&nbsp;young men&nbsp;who have hypogonadism without cardiovascular disease&nbsp;or limitations in mobility.&#8221;<\/p>\n<p><strong>Prasugrel and Cancer: Is There a Link?<\/strong>&nbsp;Two critics of prasugrel have again sought to link the drug to an increased risk of cancer.<a href=\"http:\/\/archinte.ama-assn.org\/cgi\/content\/full\/170\/12\/1078\"> The&nbsp;paper, by &nbsp;James Floyd and Victor Serebruany, appears in&nbsp;<em>Archives of Internal&nbsp;Medicine<\/em>.<\/a>&nbsp;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&nbsp;with certainty an increased risk of cancer, but say that \u201ca safety concern has been raised\u201d and that \u201cphysicians should consider the potential cancer risks before prescribing&nbsp;prasugrel, especially with prolonged use and in patients with known cancer.\u201d<\/p>\n<p>In&nbsp;<a href=\"http:\/\/archinte.ama-assn.org\/cgi\/content\/full\/170\/12\/1010\">an accompanying editorial<\/a>, Sanjay Kaul and George Diamond write that although the prasugrel-cancer connection \u201chas not been firmly established, sufficient credible&nbsp;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&nbsp;that to optimize the benefit-risk balance, prasugrel use should be limited to a duration of weeks rather than months.\u201d<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Trial Raises Concerns Over CV Safety of Testosterone Gel:&nbsp;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 [&hellip;]<\/p>\n","protected":false},"author":196,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-1573","post","type-post","status-publish","format-standard","hentry","category-general"],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/1573","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/users\/196"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/comments?post=1573"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/1573\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/media?parent=1573"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/categories?post=1573"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/tags?post=1573"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}