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Bepridil hydrochloride compared with placebo in patients with stable angina pectoris.

Abstract
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.
AuthorsK A Narahara, B N Singh, J S Karliner, S R Corday, K F Hossack
JournalThe American journal of cardiology (Am J Cardiol) Vol. 69 Issue 11 Pg. 37D-42D (Apr 09 1992) ISSN: 0002-9149 [Print] United States
PMID1553890 (Publication Type: Clinical Trial, Controlled Clinical Trial, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
Chemical References
  • Bepridil
Topics
  • Analysis of Variance
  • Angina Pectoris (drug therapy)
  • Bepridil (administration & dosage, adverse effects, therapeutic use)
  • Double-Blind Method
  • Electrocardiography (drug effects)
  • Exercise Test (drug effects)
  • Female
  • Humans
  • Male
  • Middle Aged

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