{"id":44125,"date":"2014-07-16T17:18:43","date_gmt":"2014-07-16T21:18:43","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/?post_type=voices&p=44125"},"modified":"2014-07-16T17:54:49","modified_gmt":"2014-07-16T21:54:49","slug":"hps2-thrive-the-final-chapter-in-the-niacin-story","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2014\/07\/16\/hps2-thrive-the-final-chapter-in-the-niacin-story\/","title":{"rendered":"HPS2-THRIVE: The Final Chapter in the Niacin Story?"},"content":{"rendered":"

Today\u2019s publication of findings from the HPS2-THRIVE trial<\/a> raises uncomfortable questions for physicians. Even if some subgroups who may benefit from niacin are yet to be studied, did the drug deserve to generate almost a billion dollars in sales? Could we have learned sooner about the significant increases in adverse effects that HPS2-THRIVE found?<\/p>\n

Kudos to the marketers. They took a drug that is unpleasant to take and transformed it into one of America\u2019s more lucrative drug franchises, convincing many that the proprietary form of the drug was worth the cost. HPS2-THRIVE revealed that extended-release niacin, even with the laropiprant to blunt the flushing, could not be tolerated by a third of the participants in the run-in period, and adherence across the duration of the trial was less than 80%. (Click here for CardioExchange\u2019s news coverage<\/a> of the trial.)<\/p>\n

From a regulatory standpoint, the FDA hit the nail on the head when it refused to approve Merck\u2019s combination of niacin and laropiprant in 2008<\/a>, seemingly in an effort to defer a decision until the outcomes data from HPS2-THRIVE became available. In contrast, the European Medicines Agency did approve the drug, but it promptly withdrew its approval in 2013<\/a> as the top-line results of HPS2-THRIVE were announced.<\/p>\n

Although the rationale behind the FDA\u2019s decision is not publicly available, it appeared to mark a deviation from the agency\u2019s earlier willingness to approve lipid-lowering drugs on the basis of surrogate endpoints. The FDA\u2019s approach to the novel PCSK9 inhibitors, which powerfully lower LDL but have an uncertain effect on real-world outcomes, represents an important opportunity for the agency to reaffirm its commitment to emphasizing meaningful efficacy data.<\/p>\n

Lastly, the commercial success of AbbVie\u2019s niacin product, Niaspan, is quite a story. The company booked more than $900 million in sales of the drug in 2012<\/a>, the first full year after AIM-HIGH was halted, with price increases offsetting declining prescriptions for the drug<\/a>. It went on to clock $650 million in sales in 2013<\/a>, after the HPS2-THRIVE results were first announced. Although the generic competition, which finally arrived at the end of 2013, will rapidly deplete AbbVie\u2019s cash cow, physicians who continue to prescribe niacin in great numbers may now be asking themselves why \u2014 and at what cost to patients and the health care system?<\/p>\n

Share your thoughts with us here.<\/b><\/p>\n","protected":false},"excerpt":{"rendered":"

Findings from HPS2-THRIVE raise uncomfortable questions for physicians.<\/p>\n","protected":false},"author":577,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[7],"tags":[210,2309,1605,857,858],"class_list":["post-44125","post","type-post","status-publish","format-standard","hentry","category-prevention","tag-cholesterol","tag-cordaptive","tag-hps2-thrive","tag-niacin","tag-niaspan"],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/44125","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\/577"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/comments?post=44125"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/44125\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/media?parent=44125"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/categories?post=44125"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/tags?post=44125"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}