Improved efficacy with maintained tolerability in the treatment of primary hypertension. Comparison between the felodipine-metoprolol combination tablet and monotherapy with enalapril

Abstract

In this multicentre, double-blind, parallel-group study, 120 out-patients with mild to moderate primary hypertension were randomised, after a 4-week single-blind placebo run-in period, to a combination tablet of felodipine-metoprolol 5/50 mg (Logimax^®, Mobloc^®, Astra) once daily or enalapril 10 mg once daily. If blood pressure (BP) remained suboptimally controlled after 4 weeks (supine diastolic BP >90 mm Hg 24-h post dose), the dose was doubled for a further 4 weeks. After 8 weeks felodipine-metoprolol reduced supine BP significantly more than enalapril (19.7/12.0 mm Hg and 11.1/7.2 mm Hg, respectively). The mean differences in change in BP between treatments were 8.6/4.8 mm Hg in favour of felodipine-metoprolol (P = 0.001/P <0.001). a statistically significant difference to the advantage of felodipine-metoprolol was also seen in standing bp. even though the dose was increased in a larger proportion of patients in the enalapril group (61%) than in the felodipine-metoprolol group (40%), fewer enalapril-treated patients achieved adequate bp control (41% vs 63% on felodipine-metoprolol, P <0.05). both treatments were well tolerated. three patients treated with felodipine-metoprolol and four with enalapril discontinued treatment due to adverse events. a similar number of patients reported adverse events in each treatment group. in conclusion, a combination tablet of felodipine-metoprolol 5/50–10/100 mg once daily reduced bp more effectively than enalapril 10–20 mg once daily 24 h post dose. the result was expected, but a more important observation was that both treatments were tolerated to a similar degree. obviously, a considerable bp reduction may be well tolerated, as was the main purpose to demonstrate in this study.