{"id":47958,"date":"2015-04-28T15:18:29","date_gmt":"2015-04-28T19:18:29","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/?post_type=news&#038;p=47958"},"modified":"2015-05-15T17:08:32","modified_gmt":"2015-05-15T21:08:32","slug":"cardiovascular-outcomes-with-sitagliptin-no-better-or-worse-than-conventional-care","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2015\/04\/28\/cardiovascular-outcomes-with-sitagliptin-no-better-or-worse-than-conventional-care\/","title":{"rendered":"Cardiovascular Outcomes with Sitagliptin: No Better or Worse Than Conventional Care"},"content":{"rendered":"<p>Late Monday afternoon, Merck\u00a0<a href=\"http:\/\/www.mercknewsroom.com\/news-release\/prescription-medicine-news\/merck-announces-trial-evaluating-cardiovascular-outcomes-sit\">released<\/a>\u00a0the top line results of\u00a0<a href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT00790205?term=tecos+sitagliptin&amp;rank=1\">TECOS<\/a>, the cardiovascular outcomes trial with its diabetes drug sitagliptin (Januvia). \u00a0The company said that the trial &#8220;achieved its primary endpoint of non-inferiority for the composite cardiovascular (CV) endpoint.&#8221; Merck announced only one additional detail: &#8220;Among secondary endpoints,&#8221; they reported, &#8220;there was no increase in hospitalization for heart failure in the sitagliptin group versus placebo.&#8221;<\/p>\n<p>The FDA has been wrestling for a number of years now with the problem of the cardiovascular effects&#8211; whether\u00a0positive or\u00a0negative&#8211; of diabetes drugs. The first large outcomes trials with two other DPP-4 inhibitors, saxagliptin (Onglyza,\u00a0AstraZeneca) and alogliptin (Nesina, Takeda Pharmaceuticals), were reported in 2013 and found no impact\u00a0of the drugs on cardiovascular outcomes.<\/p>\n<p>However, a troubling signal emerged suggesting a possible raised risk for heart failure, though the endpoint was not rigorously studied in the trials.\u00a0<a href=\"http:\/\/blogs.nejm.org\/cardioexchange\/news\/diabetes-drugs-get-neither-restrictions-nor-endorsements-from-fda-committee\/\">Two weeks ago the FDA&#8217;s\u00a0Endocrinologic and Metabolic Drugs Advisory Committee\u00a0reviewed the trials<\/a>\u00a0and rejected recommendations from critics for\u00a0new restrictions on their use, but they did say that information from the two clinical trials should\u00a0be added to the drugs&#8217; labels.<\/p>\n<p>Sanjay Kaul, a frequent FDA adviser, pointed out the paradox\u00a0of the large\u00a0commercial success of sitagliptin despite the absence of any proven clinical benefit:<\/p>\n<blockquote><p>&#8220;So, we have a drug that yields modest glycemic efficacy, is neutral with respect to cardiometabolic factors (lipids, weight, blood pressure), does not kill you or land you in a hospital, and yet is a blockbuster drug nearly 5 times over!\u00a0What is the big news here? That it does not kill you or land you in a hospital? Or that it is a blockbuster drug nearly 5 times over without evidence of microvascular or macrovascular outcome benefit?\u00a0Miracle of medicine or miracle of marketing?&#8221;<\/p><\/blockquote>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Late Monday afternoon, Merck\u00a0released\u00a0the top line results of\u00a0TECOS, the cardiovascular outcomes trial with its diabetes drug sitagliptin (Januvia). \u00a0The company said that the trial &#8220;achieved its primary endpoint of non-inferiority for the composite cardiovascular (CV) endpoint.&#8221; Merck announced only one additional detail: &#8220;Among secondary endpoints,&#8221; they reported, &#8220;there was no increase in hospitalization for heart [&hellip;]<\/p>\n","protected":false},"author":196,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1,7],"tags":[196,1611,1956,1011],"class_list":["post-47958","post","type-post","status-publish","format-standard","hentry","category-general","category-prevention","tag-fda","tag-merck","tag-outcomes-trials","tag-sitagliptin"],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/47958","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=47958"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/47958\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/media?parent=47958"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/categories?post=47958"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/tags?post=47958"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}