Felodipine Versus Placebo in Stable Effort-Induced Angina Pectoris in Patients Inadequately Controlled with Metoprolol—A Dose-Finding Study

Abstract

We compared the antianginal and antiischemic effect and tolerability of four different doses of felodipine extended-release (ER) tablets with placebo in patients with stable effort-induced angina pectoris treated with beta-blocker [metoprolol controlled release (CR) 100 mg once daily, o.d.]. Seventy-five patients were enrolled in the study. At the end of a 2-week single-blind period, all patients performed two exercise tests. If total exercise time did not vary by > 15% between the two tests and both tests were limited by anginal discomfort and concomitant ST depression of at least 1 mm, the patients were randomized to double-blind treatment (66 patients). Each patient received three of the following treatments: felodipine 2.5, 5, 10, or 20 mg, or placebo. The treatments were given o.d. in a cross-over, balanced incomplete block design with three of 3-week treatment periods. Exercise tests were performed 12 and 24 h after dose intake at the end of each treatment period. Fifty-nine patients completed the study. Twelve hours after dose administration, 10 and 20 mg felodipine increased time to onset of anginal pain by 60 and 63 s on the average, respectively, as compared with placebo (p = 0.001). Time to 1-mm ST depression was prolonged by 29 s after 10 mg (p = 0.14) and by 30 s after 20 mg (p = 0.13) felodipine. Time to end of exercise was increased by 28 s (p = 0.07) and 15 s (p > 0.20), respectively.(ABSTRACT TRUNCATED AT 250 WORDS)