{"id":3726,"date":"2010-10-05T18:32:35","date_gmt":"2010-10-05T22:32:35","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/?p=3726"},"modified":"2011-07-19T17:45:26","modified_gmt":"2011-07-19T21:45:26","slug":"has-subgroup-exuberance-led-to-misleading-advertising","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2010\/10\/05\/has-subgroup-exuberance-led-to-misleading-advertising\/","title":{"rendered":"Has Subgroup Exuberance Led to Misleading Advertising?"},"content":{"rendered":"<p><em>Harlan Krumholz&#8217;s <a href=\"http:\/\/blogs.nejm.org\/cardioexchange\/a-case-of-exuberance-about-a-subgroup-in-a-clinical-trial\/\">latest Journal Club installment<\/a>, which focuses on subgroup analyses from TRITON-TIMI 38, has generated great comments, including Harlan&#8217;s own new observation about how these subgroup data are being misused in advertising. Read what he has to say and share your own thoughts <a href=\"http:\/\/blogs.nejm.org\/cardioexchange\/a-case-of-exuberance-about-a-subgroup-in-a-clinical-trial\/#comments\">here<\/a>.<br \/>\n<\/em><\/p>\n<p>So I am perusing my current issue of JACC and I notice that there is an  ad for Effient (prasugrel) that is all about the subgroups in TRITON.  And the language is misleading in my opinion. They tout the reductions  in thrombotic CV events in diabetes subgroups and state, &#8220;The greater  reduction in the primary composite endpoint in patients with diabetes  treated with Effient plus ASA compared with Plavix plus ASA was  consistent with those observed in the overall UA\/NSTEMI and STEMI  populations.\u201d By saying the \u2018greater reduction\u2019 there is the suggestion  that there is a signal of great benefit \u2013 but the rest of the sentence  concedes that the effect in diabetics is no different than  non-diabetics. So why the emphasis on the greater reduction \u2013 many who  are not familiar with the study might think the drug is more effective  in diabetics \u2013 which the trial does not indicate. And there is more. For  bleeding they present a beautiful figure that shows that Effient has a  higher risk of non-CABG related major bleeding in the entire study group  (2.2% vs 1.7%) \u2014 beside it is another bar graph suggesting that the  rates in diabetes are similar (2.2% vs 2.3%) \u2013 that would be great  except that there is no evidence that the bleeding risk in diabetics is  different than non-diabetics. And in small font \u2013 very small font \u2013  under the figures, it says, \u201cP value not provided because the trial was  not designed to prospectively evaluate bleeding differences in  subgroups.\u201d I wish that were in a larger font. Take a look at the ad and  see what you think.<\/p>\n<p>To comment, join in the discussion on the <a href=\"http:\/\/blogs.nejm.org\/cardioexchange\/a-case-of-exuberance-about-a-subgroup-in-a-clinical-trial\/\">original post here<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Harlan Krumholz&#8217;s latest Journal Club installment, which focuses on subgroup analyses from TRITON-TIMI 38, has generated great comments, including Harlan&#8217;s own new observation about how these subgroup data are being misused in advertising. Read what he has to say and share your own thoughts here. So I am perusing my current issue of JACC and [&hellip;]<\/p>\n","protected":false},"author":343,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-3726","post","type-post","status-publish","format-standard","hentry","category-general"],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/3726","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\/343"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/comments?post=3726"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/3726\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/media?parent=3726"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/categories?post=3726"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/tags?post=3726"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}