Copyright © 1995 by the European Society of Cardiology.
© 1995 The European Society of Cardiology
Effects of amlodipine on transient myocardial ischaemia in patients with a severe coronary condition treated with a beta-blocker
*Clinical Pharmacology Unit, Saint-Antoine Hospital Paris, France
The Holter Monitoring Laboratory Paris, France
Statistical Unit B3E, Inserm SC4, Faculté de Médecine Saint-Antoine Paris, France
Clinical Pharmacology Department, Pitié-Salpétrière Hospital Paris, France
revised 27 January 1995; accepted 22 February 1995.
Correspondence: Tabassome Madjlessi-Simon, MD, Clinical Pharmacology Unit, Saint-Antoine Hospital, 184 Rue du Fg Saint-Antoine, 75012, Paris, France
Abstract
The purpose of this trial was to study the additional anti-ischaemic effects of amlodipine in coronary patients with ambulant ischaemia despite beta-blocker therapy. Beta-blockers are the most effective drug therapy for reducing the frequency and duration of ambulatory ischaemic episodes. However, the therapeutic advantage of combined calcium antagonist-beta-blocker treatment remains questionable.
Three hundred and thirteen patients with documented coronary artery disease, a positive exercise test within 6 months before entry and background beta-blocker therapy, were screened. Inclusion criteria (
4 episodes of transient ST segment depression of 1.0 mm and/or 20 min of ischaemia) were demonstrated in a 48 h ECG during the placebo run-in period in 84 (25%) of the patients. Eighty-nine percent of the ischaemic episodes were silent. The eligible patients were then randomized in a 2-week, double-blind, parallel group study comparing placebo to amlodipune 10 mg daily added to the beta-blocker. The anti-ischaemic efficacy of the combination therapy was assessed by 48 h ECG monitoring and exercise tests.
Compared to placebo, amlodipine did not significantly reduce either the frequency (3.7±4.3 vs 4±4.8 episodes in the amlodipune group) or the duration of ambulatory ischaemia (mean duration: 43.9±57.1 vs 39.6±65.7 min, total duration 3.1±6.7 vs 2.8±6.1 h). Exercise-induced ST segment depression tended to decrease with amlodipine (58% vs 73% in the placebo group) and the ischaemia-free workload capacity was increased (+1.7 stage vs 0.7 stage in the placebo group, P=0.08).
These results suggest that 2 weeks treatment with amlodipine may not provide any additional anti-ischaemic benefit in patients with ambulant ischaemia resistant to a beta-blocker therapy.
Key Words: Myocardial ischaemia • ambulatory ECG monitoring • amlodipine • calcium channel blocker
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