Controlled clinical trial of bepridil, propranolol and placebo in the treatment of exercise induced angina pectoris. B.I.S. Research Group.

191 patients with exercise induced angina pectoris and a mean weekly number of attacks of 11.3 were admitted in a multicentre double-blind study after an evaluation period on placebo. They were randomly assigned to: bepridil (100-400 mg/d), propranolol (60-240 mg/d), placebo ("strength" 100-400) and treated for 6 months. During the first 8 weeks the treatment was individually titrated. Withdrawal from the study was considered as "failure". 19.2% bepridil patients, 21.8% propanolol patients and 17.1% placebo patients stopped their study medication. Severe angina pectoris leading to withdrawal was not observed in bepridil group against 3 cases in placebo (P = 0.03) and 6 in propanolol groups (P = 0.02). In all groups the number of attacks was reduced between 49 and 77%. At wk 8, bepridil patients were improved compared with placebo patients (P = 0.04). Total work performed and duration of exercise on the ergometer were increased in bepridil patients at wk 8 compared with placebo patients. However, all treatment differences had vanished by wk 24. One patient died in the bepridil group, 2 in the propranolol group and none in the placebo group. The total numbers of fatal or severe non fatal cardiovascular events were not statistically significantly different. There were less severe adverse cardiovascular reactions in the bepridil group than in the propranolol group (P less than 0.03).

RCT Entities:   Population Interventions Outcomes