{"id":31312,"date":"2012-08-26T12:50:04","date_gmt":"2012-08-26T16:50:04","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/?post_type=news&#038;p=31312"},"modified":"2012-08-26T12:50:04","modified_gmt":"2012-08-26T16:50:04","slug":"first-detailed-look-at-why-aliskiren-failed-to-gain-altitude","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2012\/08\/26\/first-detailed-look-at-why-aliskiren-failed-to-gain-altitude\/","title":{"rendered":"First Detailed Look At Why Aliskiren Failed To Gain ALTITUDE"},"content":{"rendered":"<p>Last December the once-promising direct renin inhibitor aliskiren\u00a0(Rasilez, Tekturna) suffered a fatal setback with\u00a0<a title=\"ALTITUDE Study of Aliskiren Terminated Early by Novartis\" href=\"http:\/\/blogs.nejm.org\/cardioexchange\/news\/altitude-study-of-aliskiren-terminated-early-by-novartis\/\">the early termination<\/a>\u00a0of\u00a0the\u00a0<a href=\"http:\/\/clinicaltrials.gov\/ct2\/show\/study\/NCT00549757?term=ALTITUDE+aliskiren&amp;rank=1\">ALTITUDE trial<\/a>.\u00a0The trial was stopped when the Data Monitoring Committee (DMC) found an increased risk for non-fatal stroke, renal complications, hyperkalemia, and hypotension in patients taking aliskiren after 18-24 months.<\/p>\n<p>At the ESC in Munich ALTITUDE investigator Hans-Henrik Parving presented the first detailed but preliminary results from the trial, which compared aliskiren to placebo in 8,561 type 2 diabetics at high risk for cardiovascular and renal complications already receiving single RAAS blockade.<\/p>\n<p>After 32 months of followup, there was no significant difference between the two groups in the composite\u00a0endpoint: CV death, resuscitated death, MI, stroke, unplanned hospitalization for heart failure, onset of end-stage renal disease, or doubling of baseline creatinine. However, Parving noted that the numbers went in the wrong direction for aliskiren, including a trend suggesting more strokes associated with the treatment drug:<\/p>\n<ul>\n<li>Composite endpoint: 17.9% for aliskiren vs. 16.8% for placebo (HR, 1.08; 95% CI, 0.98-1.20;\u00a0<em>P<\/em>=0.142)<\/li>\n<li>Stroke: 3.4% for aliskiren vs.\u00a02.8% for placebo (HR 1.25; 95% CI, 0.98-1.60; <em>P<\/em>=0.70)<\/li>\n<\/ul>\n<p>Aliskiren-treated patients also had higher potassium levels and were more likely to develop hyperkalemia, hypotension, and diarrhea.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>This once-promising renin inhibitor was no better than placebo when it came to the composite outcome, but showed worrisome trends, especially when it came to stroke.<\/p>\n","protected":false},"author":196,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1,14,7],"tags":[660,1424],"class_list":["post-31312","post","type-post","status-publish","format-standard","hentry","category-general","category-heart-failure","category-prevention","tag-aliskiren","tag-renin-inhibition"],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/31312","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=31312"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/31312\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/media?parent=31312"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/categories?post=31312"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/tags?post=31312"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}