OBJECTIVE: To assess the long-term safety and antianginal efficacy of two doses of ivabradine, a novel selective and specific inhibitor of the sinus node I(f) current. METHODS: In a randomized double-blind, parallel-group study 386 patients with chronic stable angina were randomized to either ivabradine 5 mg b.i.d. (n = 198, group 1) or ivabradine 7.5 mg b.i.d. (n = 188, group 2) for 12 months. Concomitant medication included antithrombotic agents, lipid-lowering agents, long-acting nitrates and dihydropyridine calcium antagonists. Safety was assessed on the basis of reported adverse events at 1, 3, 6, 9 and 12 months. Antianginal efficacy was based on the reduction in the weekly number of angina attacks and in the consumption of short-acting nitrates from month 0 (baseline) to month 12. RESULTS:Ivabradine was well tolerated. Phosphene-like mild transient visual symptoms were the most frequently reported adverse events but led to treatment withdrawal in only 4 patients. Resting heart rate was reduced by 9 bpm in group 1 and 12 bpm in group 2. Sinus bradycardia caused treatment withdrawal in only three cases. The QTc (Bazett) interval did not increase. At month 12 relative to month 0 there was a significant reduction in the number of angina attacks per week. CONCLUSION:Ivabradine at the recommended doses of 5 and 7.5 mg b.i.d. was well tolerated and demonstrated antianginal efficacy in patients with documented coronary artery disease treated with concomitant antianginal medications. (c) 2007 S. Karger AG, Basel.
RCT Entities:
OBJECTIVE: To assess the long-term safety and antianginal efficacy of two doses of ivabradine, a novel selective and specific inhibitor of the sinus node I(f) current. METHODS: In a randomized double-blind, parallel-group study 386 patients with chronic stable angina were randomized to either ivabradine 5 mg b.i.d. (n = 198, group 1) or ivabradine 7.5 mg b.i.d. (n = 188, group 2) for 12 months. Concomitant medication included antithrombotic agents, lipid-lowering agents, long-acting nitrates and dihydropyridine calcium antagonists. Safety was assessed on the basis of reported adverse events at 1, 3, 6, 9 and 12 months. Antianginal efficacy was based on the reduction in the weekly number of angina attacks and in the consumption of short-acting nitrates from month 0 (baseline) to month 12. RESULTS:Ivabradine was well tolerated. Phosphene-like mild transient visual symptoms were the most frequently reported adverse events but led to treatment withdrawal in only 4 patients. Resting heart rate was reduced by 9 bpm in group 1 and 12 bpm in group 2. Sinus bradycardia caused treatment withdrawal in only three cases. The QTc (Bazett) interval did not increase. At month 12 relative to month 0 there was a significant reduction in the number of angina attacks per week. CONCLUSION:Ivabradine at the recommended doses of 5 and 7.5 mg b.i.d. was well tolerated and demonstrated antianginal efficacy in patients with documented coronary artery disease treated with concomitant antianginal medications. (c) 2007 S. Karger AG, Basel.
Authors: Richard E Cober; Karsten E Schober; Tony C A Buffington; Xiaobai Li; Sabine C Riesen; John D Bonagura Journal: J Vet Cardiol Date: 2011-10-24 Impact factor: 1.701