Additional antianginal and anti-ischemic efficacy of mibefradil in patients pretreated with a beta blocker for chronic stable angina pectoris.

Abstract

This study assessed the safety, tolerability, and efficacy of mibefradil when added to beta-blocker monotherapy in patients with chronic stable angina pectoris. Two hundred five patients were randomized to receive double-blind treatment with either placebo (n = 70), mibefradil 25 mg (n = 67), or mibefradil 50 mg (n = 68) for 2 weeks. Exercise tolerance tests (ETTs) were performed at the end of the run-in (baseline) and double-blind treatment periods, and patients maintained an anginal diary. Compared with placebo, treatment with mibefradil 50 mg resulted in significant increases in exercise duration (36 +/- 51 seconds; p = 0.036), time to onset of angina (48 +/- 65 seconds; p = 0.002), and time to persistent 1-mm ST-segment depression (47 +/- 77 seconds; p = 0.004). Greater reductions in heart rate, blood pressure, and the rate-pressure product were more apparent at each stage of the ETT in the 50-mg mibefradil group than in the placebo group. Daily treatment with mibefradil 50 mg was associated with a significant decrease in the number of weekly anginal attacks (-2.1 +/- 4.0, p = 0.020) compared with placebo. The addition of mibefradil to existing beta-blocker therapy was well tolerated. Dizziness was the most frequently reported adverse event in the mibefradil 50-mg dose, and occurred with an incidence of 4.4%. The addition of mibefradil 50 mg, administered once daily, to patients on stable beta-blocker therapy produced additive antianginal and anti-ischemic effects and was well tolerated.

• Authors: J S Alpert, I Kobrin, V DeQuattro, R Friedman, A Shepherd, P E Fenster, U Thadani
• Journal: The American journal of cardiology (Am J Cardiol) Vol. 79 Issue 8 Pg. 1025-30 (Apr 15 1997) ISSN: 0002-9149 [Print] United States
• PMID: 9114758 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Adrenergic beta-Antagonists
• Benzimidazoles
• Calcium Channel Blockers
• Tetrahydronaphthalenes
• Vasodilator Agents
• Mibefradil

Topics

• Adrenergic beta-Antagonists (therapeutic use)
• Aged
• Angina Pectoris (drug therapy)
• Benzimidazoles (adverse effects, therapeutic use)
• Calcium Channel Blockers (adverse effects, therapeutic use)
• Chronic Disease
• Dose-Response Relationship, Drug
• Double-Blind Method
• Drug Synergism
• Drug Therapy, Combination
• Exercise Test
• Female
• Humans
• Male
• Mibefradil
• Middle Aged
• Tetrahydronaphthalenes (adverse effects, therapeutic use)
• Treatment Outcome
• Vasodilator Agents (adverse effects, therapeutic use)