Bepridil is a
calcium antagonist with a unique chemical composition and a long elimination half-life (42 hours). We evaluated the efficacy of
bepridil 300 mg once/day in a crossover comparison with placebo in 45 patients with angina. Patients had an average of 7.6 anginal episodes/week during the placebo baseline phase of the trial. After 4 weeks of
bepridil therapy, anginal frequency decreased to 2.9 episodes/week (p less than 0.05). Likewise, mean
nitroglycerin consumption declined from 7.4
tablets/week during the placebo baseline phase to 4.0
tablets/week during
bepridil therapy (p less than 0.05). Statistically significant increases over the previous period (placebo baseline or double-blind placebo) were seen in total exercise time, time to angina, and total work (p less than 0.05). During
bepridil therapy, 13 of 45 patients (29%) no longer experienced angina as an exercise end point despite the increase in work and exercise time.
Bepridil significantly prolonged both the QT and corrected QT (QTc) intervals; the mean increases were 10.0% and 5.6%, respectively. Side effects were reported with equal frequency in the placebo and
bepridil arms of the trial, and no serious side effects were reported. In an intermediate fixed dose of 300 mg/day,
bepridil relieved anginal symptoms with few side effects.
Bepridil appears to be a safe and effective treatment for
stable angina.