Comparison of a fixed combination of nifedipine slow release and atenolol (Bay-R-1999) and nifedipine slow release alone in patients with stable angina pectoris : a multicenter randomized, double-blind, parallel-group study

Abstract This multicenter, randomized double-blind, parallel-group study was designed to compare the therapeutic effects of a fixed combination of atenolol 50 mg plus nifedipine slow release (SR) 20 mg twice daily (Bay-r-1999) with the effects of nifedipine SR 20 mg twice daily alone in mild to moderately symptomatic patients with stable angina pectoris. After a 2-week run-in period during which patients underwent two exercise tests and 48-hour ambulatory electrocardiographic monitoring, 72 male patients were randomized to two treatment groups. A total of 66 patients completed the study. After 4 weeks of active treatment, patients underwent a 12-hour postdosing exercise test and 48-hour ambulatory electrocardiographic monitoring. The rank analysis of variance did not show any significant between-group difference in time to 1-mm ST segment depression. ST segment depression ≥1 mm occurred in 20 of 32 patients receiving Bay-r-1999 and in 26 of 34 patients receiving nifedipine SR alone. In these patients, Bay-r-1999 increased the time to 1-mm ST segment depression from a baseline value of 400 ± 105 seconds to 519 ± 110 seconds (+30%; P P