Comparison of a felodipine-metoprolol combination tablet vs each component alone as antihypertensive therapy. The German Multicentre Study Group.

This was a 12-week double-blind, parallel-group study of 186 patients with supine diastolic blood pressure between 95 and 115 mmHg randomised to receive either 5 mg of felodipine or 50 mg of metoprolol, or a combination tablet containing the two drugs at the same dosages, given once daily. All drugs were extended-release formulations and blood pressure was measured 24 h after drug administration. After 12 weeks of treatment, the mean systolic/diastolic blood pressure reduction was significantly greater with the felodipine-metoprolol combination (28/18 mmHg) compared with felodipine (18/12 mmHg) or metoprolol (19/12 mmHg) alone. Antihypertensive response rate, defined as the percent of patients achieving a supine diastolic blood pressure < or = 90 mmHg and/or a reduction of > or = 10 mmHg with treatment, was significantly greater with the fixed combination (98%) than with either felodipine (79%) or metoprolol (82%) as monotherapy. The mean reduction in heart rate was significantly less with the combination (2 beats/min) than with metoprolol alone (4 beats/min), and heart rate was virtually unchanged in the felodipine group. The increased antihypertensive efficacy of the combination was associated with good tolerability that was similar to that of the monotherapies. Adverse events were mainly those related to arteriolar dilatation with felodipine and the combination, and dizziness and fatigue with metoprolol. Two patients taking the combination were withdrawn due to adverse events.