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European Heart Journal 1995 16(1):1780-1788;
Copyright © 1995 by the European Society of Cardiology.
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© 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

T. MADJLESSI-SIMON*,, F. FILLETTE{dagger}, M. MARY-KRAUSE{ddagger}, P. LECHAT§, P. JAILLON* and ON BEHALF OF THE AMLOR-HOLTER STUDY INVESTIGATORS

*the Clinical Pharmacology Unit, Saint-Antoine Hospital Paris, France
{dagger}The Holter Monitoring Laboratory Paris, France
{ddagger}Statistical Unit B3E, Inserm SC4, Faculté de Médecine Saint-Antoine Paris, France
§the 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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