Improved efficacy with maintained tolerability in the treatment of primaryhypertension. Comparison between the felodipine-metoprolol combination tablet and monotherapy with enalapril
Ok. Andersson, Improved efficacy with maintained tolerability in the treatment of primaryhypertension. Comparison between the felodipine-metoprolol combination tablet and monotherapy with enalapril, J HUM HYPER, 13(1), 1999, pp. 55-60
In this multicentre, double-blind, parallel-group study, 120 out-patients w
ith mild to moderate primary hypertension were randomised, after a 4-week s
ingle-blind placebo run-in period, to a combination tablet of felodipine-me
toprolol 5/50 mg (Logimax(R), Mobloc(R), Astra) once daily or enalapril 10
mg once daily. If blood pressure (BP) remained suboptimally controlled afte
r 4 weeks (supine diastolic BP >90 mm Hg 24-h post dose), the dose was doub
led for a further 4 weeks. After 8 weeks felodipine-metoprolol reduced supi
ne BP significantly more than enalapril (19.7/12.0 mmHg and 11.1/7.2 mm Hg,
respectively). The mean differences in change in BP between treatments wer
e 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-metopr
olol 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 felo
dipine-metoprolol group (40%), fewer enalapril-treated patients achieved ad
equate BP control (41% vs 63% on felodipine-metoprolol, P<0.05). Both treat
ments were well tolerated. Three patients treated with felodipine-metoprolo
l and four with enalapril discontinued treatment due to adverse events. A s
imilar 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 w
as that both treatments were tolerated to a similar degree. Obviously, a co
nsiderable BP reduction may be well tolerated, as was the main purpose to d
emonstrate in this study.