{"id":15595,"date":"2012-01-25T14:25:17","date_gmt":"2012-01-25T19:25:17","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/?post_type=news&#038;p=15595"},"modified":"2012-01-25T14:25:17","modified_gmt":"2012-01-25T19:25:17","slug":"fda-rejects-proposed-chronic-kidney-disease-indication-for-vytorin","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2012\/01\/25\/fda-rejects-proposed-chronic-kidney-disease-indication-for-vytorin\/","title":{"rendered":"FDA Rejects Proposed Chronic Kidney Disease Indication for Vytorin"},"content":{"rendered":"<p>The FDA rejected a new indication\u00a0for Merck&#8217;s Vytorin and Zetia (ezetimibe plus simvastatin and ezetimibe alone) in chronic kidney disease patients. As a consolation prize, however, the agency approved a new label for Vytorin that will incorporate the results of\u00a0<a href=\"http:\/\/www.thelancet.com\/journals\/lancet\/article\/PIIS0140-6736(11)60739-3\/fulltext\">SHARP (Study of Heart and Renal Protection)<\/a>, which found that the drug combination reduced the incidence of major vascular events in patients with chronic kidney disease.<\/p>\n<p>Merck said that the indication was not approved because the &#8220;independent contributions of ezetimibe and simvastatin were not assessed.&#8221; In\u00a0<a href=\"http:\/\/www.merck.com\/newsroom\/news-release-archive\/prescription-medicine-news\/2012_0125.html\">a press release<\/a>, Merck stated:<\/p>\n<blockquote><p>Because SHARP studied the combination of simvastatin and ezetimibe compared with placebo, it was not designed to assess the independent contributions of each drug to the observed effect; for this reason, the FDA did not approve a new indication for VYTORIN or for ZETIA\u00ae (ezetimibe) and the study&#8217;s efficacy results have not been incorporated into the label for ZETIA.<\/p><\/blockquote>\n<p>The FDA decision appears to run counter to<a title=\"FDA Advisory Committee Recommends Approval of Vytorin for Pre-Dialysis CKD Patients\" href=\"http:\/\/blogs.nejm.org\/cardioexchange\/news\/fda-advisory-committee-recommends-approval-of-vytorin-for-pre-dialysis-ckd-patients\/\">\u00a0the advice it received from its own advisory committee last November<\/a>, which voted 16-0 in favor of an indication for Vytorin in predialysis patients. However, the committee also recommended\u00a0<em>against\u00a0<\/em>an indication for dialysis patients. The committee did not vote on an indication that would have included the entire SHARP population of predialysis and dialysis patients.<\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The FDA rejected a new indication\u00a0for Merck&#8217;s Vytorin and Zetia (ezetimibe plus simvastatin and ezetimibe alone) in chronic kidney disease patients. As a consolation prize, however, the agency approved a new label for Vytorin that will incorporate the results of\u00a0SHARP (Study of Heart and Renal Protection), which found that the drug combination reduced the incidence [&hellip;]<\/p>\n","protected":false},"author":196,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1,7,16],"tags":[453,577,578,534,576],"class_list":["post-15595","post","type-post","status-publish","format-standard","hentry","category-general","category-prevention","category-vascular","tag-chronic-kidney-disease","tag-ezetimibe","tag-sharp","tag-simvastatin","tag-vytorin"],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/15595","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=15595"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/15595\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/media?parent=15595"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/categories?post=15595"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/tags?post=15595"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}