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[Multicenter long-term study of gallopamil in patients with coronary heart disease]
Insights
Gallopamil (Procorum) effectively treated coronary heart disease in 455 patients over one year, significantly reducing angina attacks and improving exercise tolerance. Tolerability was generally good, with most side effects mild.
Area of Science:
- Cardiology
- Pharmacology
Context:
- Coronary heart disease (CHD) management requires effective and well-tolerated treatments.
- Long-term efficacy and safety data are crucial for clinical practice.
Purpose:
- To evaluate the efficacy and tolerance of gallopamil in patients with confirmed coronary heart disease under real-world practice conditions.
- To assess the drug's impact on angina frequency, nitro-glycerine consumption, exercise tolerance, and ST-segment depression.
Summary:
- A 1-year study of 455 CHD patients showed gallopamil significantly reduced angina attacks (approx. 80%) and nitro-glycerine use.
- Exercise tolerance improved by ~50% with reduced ST-depression, with full efficacy typically achieved within 4 weeks.
- Therapeutic success was rated good in 73% of patients; effectiveness remained stable throughout the year.
Impact:
- Gallopamil demonstrated sustained efficacy and good tolerability in a large CHD patient cohort over one year.
- The study provides valuable real-world evidence supporting gallopamil's role in managing coronary heart disease.
- Findings suggest gallopamil is a viable long-term treatment option for improving quality of life in CHD patients.
Abstract:
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%.(ABSTRACT TRUNCATED AT 250 WORDS)