ADDITION OF FELODIPINE TO METOPROLOL VS REPLACEMENT OF METOPROLOL BY FELODIPINE IN PATIENTS WITH ANGINA-PECTORIS DESPITE ADEQUATE BETA-BLOCKADE - RESULTS OF THE FELODIPINE ER AND METOPROLOL CR IN ANGINA (FEMINA) STUDY

Aims The study aimed to compare the addition of felodipine to metoprol ol, and of the replacement of metoprolol by felodipine, with continuat ion of metoprolol, in patients with angina pectoris despite optimal be ta-blockade. Methods and results The study was double-blind, parallel, randomized and controlled, and comprised 363 patients from 27 outpati ent cardiology clinics in the Netherlands. The patients had angina and positive bicycle exercise tests despite optimal beta-blockade (restin g heart rate < 65 beats.min(-1)). Randomization waste three treatment groups: continuation of metoprolol (control), addition of felodipine t o metoprolol, and replacement of metoprolol by felodipine. Exercise te sts were repeated after 2 and 5 weeks. The main outcome measure was: e xercise result after 5 weeks, compared with baseline, between-group co mparison of changes vs control. There were no significant differences in exercise duration and onset of chest pain vs control. The addition of felodipine increased time until 1 mm ST depression (43 s, 95% confi dence interval 20-65 s), and decreased both ST depression at highest c omparable work load (0.46 mm, 95% confidence interval 0.19-0.72), and maximal ST depression (0.49mm, 95% confidence interval 0.23-0.74). Exe rcise results after replacement of metoprolol by felodipine were not d ifferent from control, apart from a significant increase in rate press ure product. Significantly more patients experienced adverse events in the felodipine monotherapy group. Conclusion Combination of metoprolo l and felodipine is to be preferred to felodipine monotherapy in patie nts who have signs and symptoms of myocardial ischaemia despite optima l beta-blockade.