{"id":8444,"date":"2011-05-26T13:15:32","date_gmt":"2011-05-26T17:15:32","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/?p=8444"},"modified":"2011-07-19T17:44:24","modified_gmt":"2011-07-19T21:44:24","slug":"nhlbi-stops-the-aim-high-trial-of-niacin","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2011\/05\/26\/nhlbi-stops-the-aim-high-trial-of-niacin\/","title":{"rendered":"NHLBI Stops the AIM-HIGH Trial of Niacin"},"content":{"rendered":"

The AIM-HIGH (Atherothrombosis Intervention in Metabolic Syndrome with Low HDL\/High Triglycerides: Impact on Global Health) trial <\/a>of niacin has been stopped early by the NHLBI. The trial was designed to test the addition of high-dose, extended-release niacin to statins in people at risk for CV events who had well-controlled LDL but low HDL and elevated triglyceride levels.<\/p>\n

The trial was stopped early after a regularly scheduled meeting on April 25, 2011 of the data and safety monitoring board (DSMB) determined that there was no difference in the rate of clinical events between the two treatment groups. As expected, niacin was effective at raising HDL and lowering triglyceride levels, but it had no effect on the composite endpoint of fatal or nonfatal MI, strokes, hospitalizations for ACS, or the rate of revascularization procedures.<\/p>\n

At an NIH press conference, the study director, Ruth McBride, reported that the annualized rate of the primary endpoint was 5.6% in the control group and 5.8% in the niacin group. In addition, there was a small and unexplained increase in the rate of ischemic strokes in the niacin arm. During the 32-month followup period, there were 28 strokes (1.6 %) in the niacin group versus 12 strokes (0.7%) in the control group. An NIH\/NIHLBI press release<\/a> noted that 9 of the 28 strokes in the niacin group “occurred in participants who had discontinued the drug at least two months and up to four years before their stroke” and that previous research has not raised a warning flag about an elevated risk of stroke associated with niacin use.<\/p>\n

Starting in 2005, 3,414 patients were enrolled in AIM-HIGH, which was funded by the NHLBI with additional support from Abbott, which also supplied the niacin formulation (Niaspan) used in the study. The NHLBI noted in its press release that several previous trials, including the ACCORD trial with fenofibrate and the ILLUMINATE trial with torcetrapib, have failed to demonstrate the beneficial effects of HDL-raising drugs.<\/p>\n

\u201cThis study sought to confirm earlier and smaller studies.,” said Susan B. Shurin, the acting director of the NHLBI, in the press release. “Although we did not see the expected clinical benefit, we have answered an important scientific question about treatment for cardiovascular disease.”<\/p>\n

\u201cThe results from AIM-HIGH should not be extrapolated to apply to potentially higher-risk patients such as those with acute heart attack or acute coronary syndromes, or in patients whose LDL cholesterol is not as well-controlled as those in AIM-HIGH,\u201d said William Boden, M.D, the co-principal investigator of the study.<\/p>\n

At the NIH press conference, Boden said he would consider using niacin in an ACS patient with an LDL level of 140 and an HDL level of 25. He expressed concern that “there will be a temptation to interpret this trial as a quote unquote negative trial.”<\/p>\n

In a statement<\/a>, the FDA said it had “made no new conclusions or recommendations regarding the use of extended-release niacin alone or in combination with simvastatin or other statins” and said it would “conduct a comprehensive review of the AIM-HIGH trial data as soon as they become available to determine their impact on the approved indications for extended-release niacin.”<\/p>\n

We appreciate all of your great comments about AIM-HIGH <\/em>\u2014 both below and at our Voices blog, “AIM-HIGH Halted: Death Knell for for the HDL Hypothesis? Six Experts Weigh In.”<\/a> To keep the discussion moving \u2014 but in one place \u2014 we’re closing out the thread below and hope that you will continue talking here<\/a>.<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"

The AIM-HIGH (Atherothrombosis Intervention in Metabolic Syndrome with Low HDL\/High Triglycerides: Impact on Global Health) trial of niacin has been stopped early by the NHLBI. The trial was designed to test the addition of high-dose, extended-release niacin to statins in people at risk for CV events who had well-controlled LDL but low HDL and elevated […]<\/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":[859,209,857,858],"class_list":["post-8444","post","type-post","status-publish","format-standard","hentry","category-general","category-prevention","tag-aim-high","tag-hdl","tag-niacin","tag-niaspan"],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/8444","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=8444"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/8444\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/media?parent=8444"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/categories?post=8444"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/tags?post=8444"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}