Amlodipine in patients with stable angina pectoris treated with beta-blockers and nitrates: A double-blind comparison with placebo

Abstract

The purpose of the study was to assess the possible additional antiischaemic effect of amlodipine- (AML) in patients with documented coronary artery disease (CAD) treated with beta-blockers and nitrates. Methods: We enrolled 32 patients with stable exertional angina verified in exercise test, and ≥ 70% luminal diameter narrowing in at least one of the major coronary arteries in angiography. The patients were randomized to receive 5 mg/day of AML or placebo in a double-blind manner. The dose was increased to 10 mg/day after 2 weeks. During a total of 6 weeks of treatment. 24-h ambulatory ECG-blood pressure monitoring and bicycle exercise test were performed at baseline, after 2 weeks, and at the end of the study Results: Compared to placebo, AML did not significantly reduce the duration or integral of ambulatory ischaemia. In exercise test the time to 0.1 mV ST segment depression, and total exercise time remained unaltered. 10 mg of AML reduced both systolic and diastolic blood pressure (126±11/82±8 at baseline vs. 116±9/74±7 mmHg (p<0.05)). Blood pressure remained unchanged after 5 mg of AML. The heart rate was not altered in 24-h ECG in either dosage AML reduced the total variability of heart rate after both doses (40±13 ms at baseline vs 38±10 ms after 5 mg/day, and 37±11 ins after 10 mg/day; both p<0.05), and very low frequency component (35±8 ms at baseline vs 34±7 ms after 5 mg/day (p±0.05), and 33±7 ms after 10 mg/day (p=0.05)) In conclusion, AML did not provide additional anti-ischaemic effect to beta-blocker-nitrate therapy in normotensive patients. The clinical significance of the possible unfavourable alteration in autonomic modulation of the heart with combination therapy in patients with CAD is unknown requires further evaluation.