PMID- 8967905
OWN - NLM
STAT- MEDLINE
DCOM- 19961220
LR  - 20131121
IS  - 0004-4172 (Print)
IS  - 0004-4172 (Linking)
VI  - 46
IP  - 9
DP  - 1996 Sep
TI  - [The effects of treatment with trapidil compared to nifedipine on physical, 
      emotional and cognitive exercise tolerance in patients with coronary heart 
      disease].
PG  - 868-74
AB  - 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.
FAU - Assmann, I
AU  - Assmann I
AD  - Klinik fur Innere Medizin, Abteilung Kardiologie, Klinikum Erfurt GmbH, Erfurt.
FAU - Lehrl, S
AU  - Lehrl S
FAU - Burkard, G
AU  - Burkard G
FAU - Strosser, W
AU  - Strosser W
LA  - ger
PT  - Clinical Trial
PT  - Comparative Study
PT  - English Abstract
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
TT  - Behandlung der korperlichen, emotionalen und kognitiven Belastbarkeit bei 
      Patienten mit koronarer Herzkrankheit unter Trapidil im Vergleich zu Nifedipin.
PL  - Germany
TA  - Arzneimittelforschung
JT  - Arzneimittel-Forschung
JID - 0372660
RN  - 0 (Vasodilator Agents)
RN  - EYG5Y6355E (Trapidil)
RN  - I9ZF7L6G2L (Nifedipine)
SB  - IM
MH  - Aged
MH  - Cognition/drug effects/physiology
MH  - Coronary Disease/*drug therapy/physiopathology/psychology
MH  - Double-Blind Method
MH  - Electrocardiography/drug effects
MH  - Emotions/drug effects/physiology
MH  - Exercise/*physiology
MH  - Exercise Test
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Nifedipine/*therapeutic use
MH  - Psychometrics
MH  - Quality of Life
MH  - Trapidil/*therapeutic use
MH  - Vasodilator Agents/*therapeutic use
EDAT- 1996/09/01 00:00
MHDA- 1996/09/01 00:01
CRDT- 1996/09/01 00:00
PHST- 1996/09/01 00:00 [pubmed]
PHST- 1996/09/01 00:01 [medline]
PHST- 1996/09/01 00:00 [entrez]
PST - ppublish
SO  - Arzneimittelforschung. 1996 Sep;46(9):868-74.