A Dose-Finding, Placebo-Controlled Study of Extended-Release Felodipine Once Daily in Treatment of Hypertension

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Abstract
Hypertensive patients received a .beta.-blocker plus placebo once daily for 4 weeks. If their diastolic blood pressure (DBP) was then 95-115 mm Hg, they were randomized to receive, in addition to the .beta.-blocker, placebo (n = 36), felodipine-extended release (ER) 10 mg (n = 36), or felodipine-ER 20 mg (n = 37) in a 4-week double-blind parallel-group trial. All medication was administered once daily and, when BP was measured 24 h after the last dose, felodipine-ER 10 mg reduced DBP by 14 .+-. 9 mm Hg (mean .+-. SD) from a mean of 103 mm Hg and felodipine-ER 20 mg reduced DBP by 18 .+-. 9 mm Hg from 101 mm Hg. The reductions in DBP with both doses of felodipine were greater than reductions with placebo (5 .+-. 8 mm Hg, from 102 mm Hg.sbd.both p < 0.001). At the end of the study, 21% of patients receiving placebo had a DBP .ltoreq. 90 mm Hg. In contrast, 69% of patients receiving felodipine-ER 10 mg and 82% receiving 20 mg attained this level. More than 90% of patients receiving 10 mg felodipine-ER once daily had a reduction in DBP > 5 mm Hg 24 h postdose. Felodipine-ER was well tolerated. Felodipine-ERonce daily is an effective antihypertensive drug for patients who require therapy in addition to a .beta.-blocker; the tolerability in this study was good, and a starting dose > 10 mg once daily is not indicated.

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