EFFECTS OF TREATMENT WITH TRAPIDIL AND NI FEDIPINE ON PHYSICAL, EMOTIONAL AND COGNITIVE EXERCISE TOLERANCE IN PATIENTS WITH CORONARY HEART-DISEASE

The present study was carried out to investigate exercise test results and the outcome of the quality of life after administration of trapid il (CAS 15421-84-8. Rocornal(R)) or nifedipine (CAS 21829-25-4) to pat ients with coronary heart disease. The characteristics of the life qua lity in combination with the results of exercise test are considered o f great importance for selecting medical treatment in patients with ch ronic stable angina pectoris. However little information is available on how this first evaluation may be used to select the best pharmacolo gical approach in individual patients. In this prospective multicentre study, 144 patients with stable angina were enrolled in 6 centres. Du e to protocol violations and drop-outs 116 patients were evaluated for tolerability; 101 patients were evaluated for efficacy. After baselin e evaluation, consisting of an exercise test and a questioning investi gating patients' anginal symptoms and several psychometric testings, t he patients were randomly allocated to double-blind treatment for 12 w eeks with either trapidil, 200 mg t.i.d. or nifedipine, 10 mg t.i.d. a ccording to a parallel group design. After 6 and 12 weeks exercise tes ts and psychometric testings were repeated. Both trapidil and nifedipi ne prolonged exercise tolerance (trapidil 39.2 % vs, nifedipine 33.3 % ) or increased the total exercise over baseline levels (trapidil 57.8 % vs. nifedipine 61.2 %). Using Mann-Whitney ii-test the SB-S-rating s cale and the physician's assessment revealed a comparable improvement of life quality (trapidil 69.4 % vs. nifedipine 80.0 %) under both tre atments. In addition patient questioning showed a significant reductio n iu angina attacks and in nitroglycerin consumption. None of the char acter istics of anginal symptoms or exercise test Save evidence for a significant difference between nifedipine and trapidil, Both drugs dem onstrated similar safety profiles (adverse events (AEs) 12.7 % for tra pidil and 11.1 % for nifedipine): four patients of the trapidil group and one of the nifedipine group discontinued The clinical trial becaus e of AEs. The results of a baseline exercise test and rating questionn aires may offer useful information for selecting medical treatment in stable angina pectoris.