Symptomatic and asymptomatic episodes of transient myocardial ischemia are well-known risk factors in patients with coronary artery disease. In a single-blind, randomized, and placebo-controlled study, the efficacy and safety of gallopamil was studied during a I-week treatment period in 25 patients with high-grade coronary artery stenosis and frequent, exercise-induced episodes of myocardial ischemia. Eighteen patients were men, and seven patients were women; the mean age ±SD was 59 ± 7 years. After a 1-week run-in period (days 1–7), all patients were treated with gallopamil 50 mg t.i.d. (days 8–14) and placebo t.i.d. (days 15–21) or vice versa. Twenty-four-hour Holter monitoring, exercise testing, and adverse effects were controlled at days 7, 14, and 21. During the run-in period, all patients suffered a mean of 5.9 ± 2.9 episodes of transient myocardial ischemia, mean ischemic duration was 38 ± 29 min/day. Gallopamil increased exercise tolerance from 7.9 to 9.8 min ( + 24%, p < 0.05) and resulted in reduction of the weekly usage of short-acting nitrates by 45% compared to placebo. During 24-h Holter monitoring, mean heart rate at the onset of ST-segment depression increased from 106 to 118 beats/min (p < 0.05). The frequency of daily ischemic episodes was reduced after gallopamil administration from 6.1 to 3.9 episodes/day (-37%, p < 0.05), the total ischemic burden decreased for symptomatic episodes by −54% (p < 0.05) and for asymptomatic episodes by 29% (p < 0.05). Gallopamil modified the circadian distribution of ischemic episodes by modifying the morning peak of transient myocardial ischemia. Adverse effects after administration of gallopamil (9 of 25 patients, 36%) were similar to those in the placebo group, except for a first-degree atrioventricular block, and did not limit therapy in any patient. In conclusion, gallopamil is an effective adjunctive medication in the treatment of patients with severe coronary artery disease and transient episodes of exercise-induced myocardial ischemia.
Copyright © 1992 Wolters Kluwer Health, Inc. All rights reserved.