{"id":47864,"date":"2015-04-16T07:48:40","date_gmt":"2015-04-16T11:48:40","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/?post_type=news&#038;p=47864"},"modified":"2015-05-15T17:08:32","modified_gmt":"2015-05-15T21:08:32","slug":"fda-approves-new-heart-failure-drug","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2015\/04\/16\/fda-approves-new-heart-failure-drug\/","title":{"rendered":"FDA Approves New Heart Failure Drug"},"content":{"rendered":"<p>The FDA on Wednesday\u00a0<a href=\"http:\/\/www.fda.gov\/NewsEvents\/Newsroom\/PressAnnouncements\/ucm442978.htm\">approved<\/a>\u00a0ivabradine (Corlanor),\u00a0Amgen&#8217;s\u00a0new heart failure drug. The drug has been available for several years in\u00a0Europe, where it is sold by\u00a0Servier under the brand names of\u00a0Corlentor and Procoralan.<\/p>\n<p>Ivabradine\u00a0was approved for the reduction of\u00a0hospitalization from worsening heart failure. It is indicated for use in stable heart-failure patients who are in sinus rhythm, have a resting heart rate of at least 70 bpm, and who are also taking the highest tolerable dose of a beta blocker. Ivabradine slows the rate of the heart by inhibiting the so-called \u201cfunny\u201d current within the heart\u2019s natural pacemaker, the sinoatrial node. The\u00a0drug\u00a0received an expedited review under the FDA\u2019s priority review program.<\/p>\n<p>Approval was based on results of the\u00a0<a href=\"http:\/\/www.thelancet.com\/journals\/lancet\/article\/PIIS0140-6736(10)61259-7\/fulltext\">SHIFT<\/a>\u00a0trial, published in 2010, which studied\u00a06,558 patients with heart failure who had a heart rate\u00a0&gt;\u00a070 bpm. After a median 22 months of followup, the rate of cardiovascular death or hospital admission for worsening heart failure was 24% in the ivabradine group and 29% in the placebo group (HR 0.82, 95% CI 0.75\u20130.90, p&lt;0.0001).<\/p>\n<p>The FDA said that that the most common side effects\u00a0of the drug were\u00a0bradycardia, hypertension, atrial fibrillation, and temporary vision disturbance (flashes of light). The FDA said that ivabradine can cause harm to fetuses and that women should not become pregnant while taking it.<\/p>\n<p>In\u00a0Europe\u00a0ivabradine has been approved for use for both heart failure and stable angina. In 2014 results from a 19,000 patient\u00a0stable-angina trial, <a href=\"http:\/\/blogs.nejm.org\/cardioexchange\/news\/signify\/\">SIGNIFY<\/a>, prompted the European Medicines Agency (EMA) to\u00a0make<a href=\"http:\/\/www.forbes.com\/sites\/larryhusten\/2014\/11\/24\/european-review-confirms-increased-risk-with-servier-and-amgen-drug\/\">\u00a0several recommendations<\/a>\u00a0intended to lower the risk of heart problems linked to the\u00a0drug. Although the overall results of SIGNIFY were neutral, troubling findings occurred in the very large subgroup (more than 12,000 patients) with symptomatic angina. The EMA review concluded that in these patients ivabradine, compared with placebo, had a small but significant increase in the risk of CV death and nonfatal MI (3.4% vs. 2.9% yearly incidence rates) and a substantially higher risk of bradycardia (17.9% vs. 2.1%).\u00a0The EMA said ivabradine was also associated with an increased risk for atrial fibrillation. SIGNIFY tested a higher dose of ivabradine, but the EMA concluded that\u00a0\u00a0the high dose &#8220;did not fully explain the findings.&#8221;<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The FDA on Wednesday\u00a0approved\u00a0ivabradine (Corlanor),\u00a0Amgen&#8217;s\u00a0new heart failure drug. The drug has been available for several years in\u00a0Europe, where it is sold by\u00a0Servier under the brand names of\u00a0Corlentor and Procoralan. Ivabradine\u00a0was approved for the reduction of\u00a0hospitalization from worsening heart failure. It is indicated for use in stable heart-failure patients who are in sinus rhythm, have a [&hellip;]<\/p>\n","protected":false},"author":196,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[14],"tags":[1636,196,343,2542],"class_list":["post-47864","post","type-post","status-publish","format-standard","hentry","category-heart-failure","tag-amgen","tag-fda","tag-ivabradine","tag-servier"],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/47864","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=47864"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/47864\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/media?parent=47864"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/categories?post=47864"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/tags?post=47864"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}