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

This multicenter, randomized, double-blind, parallel-group study was d esigned to compare the therapeutic effects of a fixed combination of a tenolol 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. A fter a 8-week run-in period during which patients underwent two exerci se tests and 48-hour ambulatory electrocardiographic monitoring, 72 ma le patients were randomized to two treatment groups, A total of 66 pat ients completed the study, After 4 weeks of active treatment, patients underwent a 12-hour postdosing exercise test and 48-hour ambulatory e lectrocardiographic monitoring. The rank analysis of variance did not show any significant between-group difference in time to l-mm ST segme nt depression, ST segment depression greater than or equal to 1 mm occ urred in 20 of 32 patients receiving Bay-r-1999 and in 26 of 34 patien ts receiving nifedipine SR alone, In these patients, Bay-r-1999 increa sed the time to l-mm ST segment depression from a baseline value of 40 0 +/- 105 seconds to 519 +/- 110 seconds (+30%; P < 0.0001) and nifedi pine SR from 398 +/- 108 seconds to 482 +/- 130 seconds (+21%; P < 0.0 001), The difference between the groups was not statistically signific ant, Similarly, no statistically significant intergroup differences we re observed in relation to the effects of the two treatments on the fr equency or duration of ambulatory electrocardiographic monitoring-dete cted ischemic episodes, the weekly frequency of anginal episodes, or n itroglycerin consumption, Unwanted side effects were reported less fre quently in the fixed combination group than in the nifedipine group (3 % vs 19%, respectively), but these differences were not statistically significant. In conclusion, this study suggests that combined treatmen t with atenolol and nifedipine SR does not provide additional antiangi nal or anti-ischemic effects compared with monotherapy with nifedipine SR in mild to moderately symptomatic patients with stable angina pect oris. Adding atenolol to nifedipine SR may, however, result in a reduc ed frequency of unwanted side effects.