Analysis of arrhythmias in the Circadian Antiischemia Program in Europe (CAPE) study.

Abstract

The aim of this study was to analyze whether, in patients with long-standing (>4 years) coronary artery disease (CAD), the addition of the long-acting calcium channel blocker (CCB) amlodipine to conventional treatment [beta-blockers (BBLs) and nitrates] during anginal attacks would have a proarrhythmic effect. This was tested by analyzing data from patients who had taken part in the Circadian Anti-ischemia Program in Europe (CAPE) trial. After a 2-week, single-blind, run-in period (Phase 1), patients were randomized to amlodipine, 5 mg/day (first 4 weeks) and 10 mg/day (second 4 weeks), or placebo for 8 weeks (Phase 2). The 48-h Holter data were analyzed for 167 amlodipine-treated patients and 83 placebo patients based on a 2:1 randomization scheme. Sixty-three per cent of amlodipine patients and 67% of placebo patients were receiving concomitant BBLs, and >90% had taken sublingual nitrates during anginal attacks, as basic antiischemic therapy. After 7 weeks of therapy, when 48-h Holter monitoring was repeated, there were no significant changes in the frequency of ventricular arrhythmias in the placebo or amlodipine groups for all patients or subgroups of patients with or without BBLs. Also, between-group comparisons showed no significant differences in arrhythmias between amlodipine and placebo patients. In summary, amlodipine (5-10 mg/day) given to patients with severe, chronic CAD receiving conventional antiischemic therapy, did not produce any proarrhythmic effects.