ADDITIONAL ANTIANGINAL AND ANTIISCHEMIC EFFICACY OF MIBEFRADIL IN PATIENTS PRETREATED WITH A BETA-BLOCKER FOR CHRONIC STABLE ANGINA-PECTORIS

This study assessed the safety, tolerability, and efficacy of mibefrad il when added to beta-blocker monotherapy in patients with chronic sta ble angina pectoris. Two hundred five patients were randomized to rece ive double-blind treatment with either placebo (n = 70), mibefradil 25 mg (n = 67), or mibefradil 50 mg (n = 68) for 2 weeks. Exercise toler ance tests (ETTs) were performed at the end of the run-in (baseline) a nd 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 t ime to persistent 1-mm ST-segment depression (47 +/- 77 seconds; p = 0 .004). Greeter 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 m ibefradil 50 mg was associated with a significant decrease in the numb er of weekly anginal attacks (-2.1 +/- 4.0, p = 0.020) compared with p lacebo. The addition of mibefradil to existing beta-blocker therapy wa s well tolerated. Dizziness was the most frequently reported adverse e vent in the mibefradil 50-mg dose, and occurred with an incidence of 4 .4%. The addition of mibefradil 50 mg, administered once daily, to pat ients on stable beta-blocker therapy produced additive antianginal and anti-ischemic effects and was well tolerated. (C) 1997 by Excerpta Me dica, Inc.