Felodipine-metoprolol combination tablet: A valuable option to initiate antihypertensive therapy?

The aim of the present study was to assess the efficacy and tolerability of a calcium antagonist/beta-blocker fixed combination tablet used as first-l ine antihypertesnive therapy in comparison with an angiotensin converting e nzyme inhibitor and placebo. Patients with uncomplicated essential hyperten sion (diastolic blood pressure between 95 and 110 mm Hg at the end of a ii- week run-in period) were randomly allocated to a double-blind, 12-week trea tment with either a combination tablet of felodipine and metoprolol (Logima x), 5/50 mg daily (n = 321), enalapril, 10 mg daily (n = 321), or placebo ( n = 304), with the possibility of doubling the dose after 4 or 8 weeks of t reatment if needed (diastolic blood pressure remaining >90 mm Hg). The comb ined felodipine-metoprolol treatment controlled blood pressure (diastolic l ess than or equal to 90 mm Hg 24 h after dose) in 72% of patients after 12 weeks, as compared with 49% for enalapril and 30% for placebo. A dose adjus tment was required in 38% of patients receiving the combination, in 63% of patients allocated to placebo, and 61% of enalapril-treated patients. The o verall incidence of adverse events was 54.5% during felodipine-metoprolol t reatment; the corresponding values for enalapril and placebo were 51.7% and 47.4%, respectively. Withdrawal of treatment due to adverse events occurre d in 18 patients treated with the combination, in 10 patients on enalapril, and 12 patients on placebo. No significant change in patients' well-being was observed in either of the three study groups. These results show that a fixed combination tablet of felodipine and metoprolol allows to normalize blood pressure in a substantially larger fraction of patients than enalapri l given alone. This improved efficacy is obtained without impairing the tol erability. The fixed-dose combination of felodipine and metoprolol, therefo re, may become a valuable option to initiate antihypertensive treatment. Am J Hypertens 1999;12:915-920 (C) 1999 American Journal of Hypertension, Ltd .