EFICACITE ANTI-ANGINEUSE DU BEPRIDOL, INHIBITEUR CALCIQUE D'ACTION PROLONGEE: RESULTATS D'UNE ETUDE CONTROLEE CONTRE PLACEBO, MULTICENTRIQUE, DE 10 SEMAINES

Bepridil, a new slow channel blocking agent with a plasma half life of > 50 hours, was compared to placebo in 77 patients with chronic angina, each of whom had ≥ 3 anginal attacks/week and a positive treadmill exercise test characterized by pain and an ST segment change ≥0.1 mV. The effects on resting and maximal exercise hemodynamics, angina frequency and NTG tablet consumption were assessed during 5 sequential 2 week treatment phases (initial placebo, bepridil 200 mg, 30 mg and 400 mg per day followed by a final placebo phase). In addition, QD verses BID regimens were compared in double blind fashion. Bepridil (300 mg/day) reduced the angina frequency 61% (from 8,8 ± 10 (SD) to 3.4 ± 6 attacks/week, p <0.001) and NTG use 70% (p <0.001). Bepridil improved the exercise duration 25% (from 7.2 ± 2.4 to 9.0 ± 2.6 minutes, p <0.001) and the exercise work by 35% (p <0.001) without producing changes in heart rate or blood pressure. The efficacy of QD or BID administrations were similar. Bepridil (200 mg/day) produced less improvement than 300 mg/day; whereas 400 mg/day added few further benefits. No peripheral vascular, AV nodal or adverse inotropic or electrocardiographic effects were observed. A minority of patients reported tremor and/or minor GI disturbances. In this large group of patients with chronic angina, bepridil was found to be an effective and well tolerated antianginal agent when given once daily.