The aim of the study was to identify the most appropriate dosage combinatio
n of ramipril and felodipine ER tan extended release tablet) for mild-to-mo
derate hypertension.
Hypertensive patients (N=507) with supinediastolic blood pressure (DBP) val
ues between 100-115 mmHg were included in a randomized, multicenter, double
-blind study of 3 x 4 factorial design with a 2 - 4 week single-blind, plac
ebo run-in and 6 week active treatment phase.
The patients were randomized to 12 groups: placebo, ramipril (2.5, 5, 10 mg
), felodipine ER (5, 10 mg), or ramipril-felodipine ER combinations (2.5/5
mg, 2.5/10 mg, 5/5 mg, 5/10 mg, 10/5 mg, 10/10 mg).
Although the greatest reductions in blood pressure were observed with ramip
ril-felodipine ER (10/10 mg), consideration of the antihypertensive efficac
y and safety factors suggest that the ramipril-felodipine ER (5/5 mg) combi
nation has the Best efficacy/tolerability ratio of the combinations tested.
The incidence of adverse events with ramipril-felodipine ER combination th
erapy was similar to that with felodipine ER monotherapy, but peripheral ed
ema, tachycardia and vasodilatation occurred less frequently with ramipril-
felodipine ER (5/5 mg) combination than with felodipine ER monotherapy. The
combination of ramipril-felodipine ER (5/5 mg) can be considered to be the
most suitable option for hypertensive patients with an inadequate response
to either of the monocomponents.