Controlled Clinical Trial of Bepridil, Propranolol and Placebo in the Treatment of Exercise Induced Angina Pectoris

Abstract

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).

Resource allocation for chronic stable angina: a systematic review of effectiveness, costs and cost-effectiveness of alternative interventions.

“…Adverse effects were reported for the comparisons between propranolol and bepridil, and between nadolol and amlodipine. In the case of propranolol and bepridil, there were no differences in numbers of fatal or severe non-fatal events, although less severe cardiovascular events were more commonly reported with bepridil use (Destors, et al, 1989). There were no differences between groups in terms of non-cardiac events (including psychiatric side-effects).…”

Economic impact of Elantan LA compared to Isordil, Tenormin and Tildiem LA in the treatment of stable angina in the UK

“…Also, the analysis did not consider the clinical consequences of angina, such as MI or death, as a result of However, the four drug classes examined in this study are equally effective in the treatment of angina [9][10][11][12][13][14][15][16] and there is no evidence to suggest that the incidence of such outcomes would vary between them, although this needs to be validated with a systematic review of the literature. The analysis was limited to those patients who remained on the same treatment for at least one year in the UK Mediplus® database.…”

“…6 Of these, about 10% will either have a non-fatal myocardial infarction or die from coronary causes. [9][10][11][12][13][14][15] Furthermore, there is no evidence that combination therapy is more effective than monotherapy. Additionally, interventions should be accompanied by risk factor modification, such as smoking cessation, increased exercise, weight reduction and dietary change.…”

Effective management of stable angina

“…These studies show no major diVerences between the main classes of drug treatment. [8][9][10][11][12][13][14][15] There is also no evidence that combination treatment is more eVective than monotherapy, 16 17 and no evidence of major treatment related diVerences in health related quality of life.…”