Antianginal efficacy of the combination of felodipine-metoprolol 10/100 mgcompared with each drug alone in patients with stable effort-induced angina pectoris: A multicenter parallel group study

Objective The primary objective of this randomized, double-blind, parallel group trial was to compare the antianginal and antiischemic efficacy of a c ombination tablet of felodipine-metoprolol 10/100 mg once daily with both d rugs given separately once daily in patients with stable effort-induced ang ina pectoris. The secondary objective was to compare the tolerability of th e 3 treatments. Methods The main criteria For inclusion were stable effort-induced angina p ectoris For at least 2 months before the enrollment and a positive bicycle exercise test result. Patients were allocated to once-daily treatment with either felodipine-metoprolol 10/100 mg, Felodipine 10 mg, or metoprolol 100 mg. The duration of active double-blind treatment was 4 weeks. There were 3 primary efficacy variables in the study; time until end of exercise,time until onset of chest discomfort, and time until 1-mm ST depression during a standardized exercise test. Results:The number of patients randomized was 397. There was a statisticall y significant improvement in time until end of exercise with felodipine-met oprolol 10/100 mg compared with metoprolol 100 mg (P = .04) and felodipine 10 mg compared with metoprolol 100 mg (P = .03). However, for time until on set of pain or time until l-mm ST-depression there were no significant diff erences among the treatment groups. At highest comparable workload, ST depr ession was less pronounced with felodipine-metoprolol than with metoprolol alone (P = .04), and the rate-pressure product was significantly lower in t he groups receiving felodipine-metoprolol and metoprolol than in the group receiving felodipine alone. The combination and metoprolol were better tole rated than Felodipine alone. Conclusions In stable angina pectoris, the combination felodipine-metoprodo l 10/100 mg and felodipine 10 mg alone increased exercise time compared wit h metoprolol 100 mg. The combination tablet and metoprolol 100 mg alone sho wed a more Favorable tolerability profile than felodipine 10 mg alone.