{"id":46119,"date":"2014-11-24T15:54:29","date_gmt":"2014-11-24T20:54:29","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/?post_type=news&#038;p=46119"},"modified":"2014-11-24T15:54:29","modified_gmt":"2014-11-24T20:54:29","slug":"european-review-confirms-increased-risk-for-ivabradine","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2014\/11\/24\/european-review-confirms-increased-risk-for-ivabradine\/","title":{"rendered":"European Review Confirms Increased Risk with Ivabradine"},"content":{"rendered":"<p>Following a review provoked by troubling findings that emerged from a large clinical trial, the European Medicines Agency (EMA) is making several recommendations intended to lower the risk of heart problems linked to the heart-rate-lowering drug ivabradine. The drug\u00a0is marketed by Servier in Europe under\u00a0the brand names of Corlentor and Procoralan and is indicated for the treatment of heart failure and stable angina. The drug\u00a0is not available in the U.S. but is under development by\u00a0Amgen\u00a0for the indication of heart failure.<\/p>\n<p><a href=\"http:\/\/www.ema.europa.eu\/ema\/index.jsp?curl=pages\/news_and_events\/news\/2014\/11\/news_detail_002217.jsp&amp;mid=WC0b01ac058004d5c1#press-release\">The review by the EMA&#8217;s\u00a0Pharmacovigilance Risk Assessment Committee (PRAC)<\/a> concluded that ivabradine &#8220;should only be started if the patient\u2019s resting heart rate is at least 70 beats per minute.&#8221; The drug should only be used for the symptomatic relief of angina because it &#8220;has not been shown to provide benefits such as reducing the risk of heart attack or cardiovascular death.&#8221;<\/p>\n<p>The committee also recommended that ivabradine should not be prescribed along with verapamil or diltiazem, drugs that also lower the heart rate. In addition, patients taking ivabradine should be monitored for atrial fibrillation and if AF develops the physician should re-evaluate treatment with ivabradine.<\/p>\n<p>Concern about ivabradine emerged earlier this year due to results of the very large <a href=\"http:\/\/blogs.nejm.org\/cardioexchange\/news\/signify\/\">SIGNIFY<\/a> study testing a high dose of ivabradine in more than 19,000 patients with stable angina. Although the overall results were neutral, troubling findings occurred in the very large subgroup (more than 12,000 patients) with\u00a0symptomatic angina. The EMA review concluded that in these patients ivabradine, compared with placebo, had a\u00a0small 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%). Also, the rate of AF was 5.3% in the ivabradine group compared with 3.8% in the placebo group. The EMA also examined additional data that confirmed the increased risk of AF in ivabradine patients.<\/p>\n<p>The EMA said that the higher than recommended dose of ivabradine used in SIGNIFY &#8220;did not fully explain the findings.&#8221; But it repeated its guidance that the initial dose of ivabradine for angina should be no greater than 5 mg twice a\u00a0day and \u00a0that the maximum dose should not exceed 7.5 mg twice a day.<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Following a review provoked by troubling findings that emerged from a large clinical trial, the European Medicines Agency (EMA) is making several recommendations intended to lower the risk of heart problems linked to the heart-rate-lowering drug ivabradine. The drug\u00a0is marketed by Servier in Europe under\u00a0the brand names of Corlentor and Procoralan and is indicated for [&hellip;]<\/p>\n","protected":false},"author":196,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13,1,14],"tags":[989,430,343,2355],"class_list":["post-46119","post","type-post","status-publish","format-standard","hentry","category-electrophysiology","category-general","category-heart-failure","tag-chmp","tag-ema","tag-ivabradine","tag-signify"],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/46119","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=46119"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/46119\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/media?parent=46119"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/categories?post=46119"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/tags?post=46119"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}