IVABRADINE APPROVED IN EUROPE

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The European Commission has approved ivabradine (Procoralan) for the symptomatic treatment of chronic stable angina pectoris in patients with normal sinus rhythm who have a contraindication or intolerance to beta-blockers. The approval allows use of the drug in 27 member states of the EU.

The approval was based on data from four double-blind, randomized trials that compared the antianginal and anti-ischemic efficacy of ivabradine with placebo, atenolol, and amlodipine in 3,222 patients. Results obtained using a standardized exercise tolerance test showed that twice-daily administration of ivabradine, at 5 mg and 7.5 mg, significantly decreased the incidence of anginal episodes.