Stable CAD study shows no benefit with ivabradine

Servier (Neuilly-sur-Seine, France) reported data from the SIGNIFY trial showing that its Procoralan ivabradine missed the primary endpoint of reducing the incidence of a composite of cardiovascular death or nonfatal myocardial infarction vs. placebo in 19,102 patients with stable coronary artery disease (CAD) without clinical heart failure. Servier markets the drug in more than 100 countries, including those of the EU, to treat stable angina and chronic heart failure (CHF).

At a median follow-up of 27.8 months, the incidence of the composite endpoint for ivabradine was 6.8% vs. 6.4% for placebo (p=0.2). In a subgroup of patients with activity-limiting angina, ivabradine significantly increased the incidence of the composite endpoint (7.6% vs. 6.5%, p=0.02). Data were presented at the European Society of Cardiology meeting in Barcelona and Amgen Inc. (NASDAQ:AMGN) for the selective If channel inhibitor to treat CHF. Amgen has exclusive U.S. commercialization rights to ivabradine from Servier. Amgen said data from SIGNIFY were not included in the NDA submission since the trial evaluated patients with CAD without heart failure (see BioCentury Extra, Aug. 27). ...