Multicenter long-term study of gallopamil in patients with coronary heart disease
Sućić, M.; Schiemann, J.
Arzneimittel-Forschung 34(11): 1587-1594
1984
ISSN/ISBN: 0004-4172 PMID: 6543136 Document Number: 224002
Efficacy and tolerance of gallopamil (Procorum) were investigated over a period of 1 year under practice conditions in a total of 455 patients (254 male, 201 female), aged 62 years (male) and 66 (female) on an average, with electrocardiographically confirmed coronary heart disease. The most frequently applied dosage was 1 film-coated tablet of gallopamil 50 mg 2-3 times daily. Frequency of attacks and nitro consumption as criteria of efficacy decreased by an average of approx. 80% in comparison to the placebo period. Full effectiveness was usually reached 4 weeks after start of therapy. ST-depression under exercise diminished by approx. 50%. An improved exercise tolerance was likewise observed, especially in patients who only tolerated up to 100 Watt prior to therapy. Therapeutic success was defined as good in 73% of the cases, satisfactory in 17.3% and insufficient in 6.7% by the trial physicians - the patient's opinion also being taken into consideration. A decrease of effectiveness was not observed during the one-year therapy. No uniform influence on the laboratory parameters could be revealed. The most frequent side-effects were: gastric discomfort (13 patients), bradycardia (7 patients) and AV-prolongation (3 patients). A total of 77 patients (16.9%) had to discontinue therapy. 29 out of these discontinuations were not therapy-related (drop-outs); 12 were based on an insufficient therapeutic success, 13 on hospitalization, 11 on extracardiac, 4 on cardiac adverse reactions and 8 patients (1.8%) died during the study. In a global assessment the trial physicians described the tolerability as good in 92% of the patients, fair in 2.9% and poor in 2.4%.