A 6-Week Double-Blind Comparison of Amlodipine and Placebo in Patients with Stable Exertional Angina Pectoris Receiving Concomitant β-Blocker Therapy

Abstract

This study was a multicenter, double-blind comparison of the antianginal efficacy and safety of amlodipine and placebo as adjunctive therapy with constant recommended maintenance doses of beta-blockers. Patients with stable exertional angina pectoris were randomized to placebo or amlodipine at a starting dose of 5 mg once daily. The amlodipine dose was adjusted to 10 mg daily after 2 weeks if angina attacks were not abolished. Antianginal efficacy was assessed throughout the study with angina diaries, investigators' and patients' global evaluations, and with bicycle exercise tests during a placebo run-in period (baseline) and after 2 and 6 weeks of double-blind treatment. On baseline-final analysis, the exercise time to angina onset increased by 13% with amlodipine compared to 6% with placebo (p < 0.05). The total exercise time increased by 11% on amlodipine compared with 2% on placebo, though this difference did not reach statistical significance. Angina attack frequency and nitroglycerin consumption were both reduced by adding amlodipine to beta-blocker treatment. Amlodipine in combination with beta-blocker therapy was well tolerated, with a low incidence of side effects and laboratory test abnormalities. The study showed clearly that addition of amlodipine to beta-blocker therapy in patients with stable angina pectoris was well tolerated and gave improved antianginal efficacy.