FELODIPINE-ER ONCE DAILY AS MONOTHERAPY IN HYPERTENSION

One hundred and one hypertensive patients [diastolic pressure (dBP) 95-110 mm Hg after ≥6 weeks with no antihypertensive therapy] were randomized to receive, double-blind, felodipine-ER 5 mg once daily (n = 49) or placebo (n = 52) for 2 weeks. Twenty-four hours post-dose, felodipine-ER 5 mg o.m. reduced dBP by a mean of 11 mm Hg; in contrast, dBP fell in the placebo group by 3 mm Hg (p < 0.001). If the target dBP of ≤90 mm Hg was not attained at 2 weeks, the dose of felodipine-ER (or placebo) was doubled; if the target was not attained after a further 2 weeks, the doses were doubled again, to 20 mg felodipine-ER or placebo. If the target was achieved after 2 or 4 weeks, patients remained on that dose; the double-blind period for all patients was 6 weeks. After 6 weeks, the mean reduction in dBP in the felodipine-ER group was 14 mm Hg, significantly (p < 0.001) greater than in the placebo group (8 mm Hg). Blood pressure "control" was defined prospectively as a seated dBP ≤s90 mm Hg: after 6 weeks, 67% of patients receiving felodipine-ER compared with 27% on placebo had a controlled blood pressure (p < 0.001). The figures after 2 weeks were 45% on 5 mg felodipine-ER and 21% on placebo (p < 0.05). The tolerability of felodipine was generally good with any side effects (e.g., flushing, headache, ankle edema) being predictable in nature. In this study, felodipine did not evoke postural hypotension or tachycardia despite a significant reduction in blood pressure. Felodipine-ER once daily is suitable as monotherapy for mild to moderate hypertension, and a starting dose of 5 mg is appropriate for these patients. © 1990 Raven Press, Ltd., New York.