[The effects of treatment with trapidil compared to nifedipine 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 trapidil (CAS 15421-84-8, Rocornal) or nifedipine (CAS 21829-25-4) to patients with coronary heart disease. The characteristics of the life quality in combination with the results of exercise test are considered of great importance for selecting medical treatment in patients with chronic stable angina pectoris. However, little information is available on how this first evaluation may be used to select the best pharmacological approach in individual patients. In this prospective multicentre study, 144 patients with stable angina were enrolled in 6 centres. Due to protocol violations and drop-outs 116 patients were evaluated for tolerability; 101 patients were evaluated for efficacy. After baseline evaluation, consisting of an exercise test and a questioning investigating patients' anginal symptoms and several psychometric testings, the patients were randomly allocated to double-blind treatment for 12 weeks with either trapidil, 200 mg t.i.d. or nifedipine, 10 mg t.i.d. according to a parallel group design. After 6 and 12 weeks exercise tests and psychometric testings were repeated. Both trapidil and nifedipine 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 U-test the SB-S-rating scale and the physician's assessment revealed a comparable improvement of life quality (trapidil 69.4% vs. nifedipine 80.0%) under both treatments. In addition patient questioning showed a significant reduction in angina attacks and in nitroglycerin consumption. None of the characteristics of anginal symptoms or exercise test gave evidence for a significant difference between nifedipine and trapidil. Both drugs demonstrated similar safety profiles (adverse events (AEs) 12.7% for trapidil and 11.1% for nifedipine); four patients of the trapidil group and one of the nifedipine group discontinued the clinical trial because of AEs. The results of a baseline exercise test and rating questionnaires may offer useful information for selecting medical treatment in stable angina pectoris.
Assmann
I
I
Klinik für Innere Medizin, Abteilung Kardiologie, Klinikum Erfurt GmbH, Erfurt.
Lehrl
S
S
Burkard
G
G
Strösser
W
W
D000368:Aged; D003071:Cognition / Q000187:drug effects / Q000502:physiology; D003327:Coronary Disease / Q000188:drug therapy* / Q000503:physiopathology / Q000523:psychology; D004311:Double-Blind Method; D004562:Electrocardiography / Q000187:drug effects; D004644:Emotions / Q000187:drug effects / Q000502:physiology; D015444:Exercise / Q000502:physiology*; D005080:Exercise Test; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009543:Nifedipine / Q000627:therapeutic use*; D011594:Psychometrics; D011788:Quality of Life; D014192:Trapidil / Q000627:therapeutic use*; D014665:Vasodilator Agents / Q000627:therapeutic use*
D014665:Vasodilator Agents; D014192:Trapidil; D009543:Nifedipine
Behandlung der körperlichen, emotionalen und kognitiven Belastbarkeit bei Patienten mit koronarer Herzkrankheit unter Trapidil im Vergleich zu Nifedipin.