Comparative study of the efficacy and tolerability of bepridil and diltiazem in unstable angina. 277 patients

• Published in: Annales de cardiologie et d'angéiologie Vol. 43; no. 2; p. 77
• Main Authors: Bory, M, Quilliet, L
• Format: Journal Article
• Language: French
• Published: France 01-02-1994
• Subjects: Aged; Angina, Unstable - drug therapy; Angina, Unstable - physiopathology; Bepridil - adverse effects; Bepridil - therapeutic use; Blood Pressure; Coronary Angiography; Diltiazem - adverse effects; Diltiazem - therapeutic use; Drug Evaluation; Electrocardiography; Female; Heart Rate; Humans; Male; Middle Aged
• ISSN: 0003-3928

Bepridil has been used only rarely in unstable angina since its long half-life could imply a delayed action. A loading dose could deal with this disadvantage. In order to confirm this hypothesis, a randomised trial was undertaken involving a 5 day comparison of bepridil at the dose of 300 mg/day after a loading dose (900 mg on D1, 500 mg on D2 and D3) with diltiazem 360 mg/day in 277 patients: 210 men and 67 women, with a mean age of 62.1 +/- 9.5, suffering from unstable angina confirmed by an ECG during symptomatic events showing reversible ST depression. A continuous 72 hour ECG record was obtained in 82 patients. Because of 69 inclusion errors, only 208 patients provided evaluable data (110 with bepridil and 98 with diltiazem), including 55 with continuous ECGs. Mortality (4.5% bepridil v. 3.1% diltiazem) and premature treatment terminations for therapeutic inefficacy (4.5% bepridil v. 7.1% diltiazem), myocardial infarction (3.6% bepridil v. 3% diltiazem), adverse events (3.6% bepridil v. 3% diltiazem) or at the patient's request (0.9% bepridil) were similar between the 2 groups. Efficacy regarding angina was similar, with 18.2% recurrences with bepridil and 21.4% with diltiazem during the first 72 hours, persisting without any difference beyond 72 hours. Resulting treatment adjustments concerning nitrates were identical in the 2 groups. Among the 55 patients with an evaluable continuous ECG (27 bepridil and 28 diltiazem, NS), 18 had recurrent ischemic episodes (9 bepridil and 9 diltiazem), 72.2% of which were clinically silent. Their total number, total duration and maximum amplitude of ST depression were similar in the 2 groups.