Monotherapy with felodipine, a new calcium antagonist, in mild and moderate hypertension

• Published in: Journal of cardiovascular pharmacology Vol. 10 Suppl 10; p. S111
• Main Authors: Hamilton, D V, Barnes, P C, Bowles, R M, Rajaratnam, D V, Comerford, M B, Ginks, W R, Ginks, S E, Goves, J R, Grabau, W J, Malcolm, J P
• Format: Journal Article
• Language: English
• Published: United States 1987
• Subjects: Administration, Oral; Adult; Aged; Antihypertensive Agents - adverse effects; Antihypertensive Agents - therapeutic use; Blood Pressure; Double-Blind Method; Felodipine; Heart Rate; Humans; Hypertension - drug therapy; Hypertension - physiopathology; Middle Aged; Myocardial Infarction - chemically induced; Nitrendipine - adverse effects; Nitrendipine - analogs & derivatives; Nitrendipine - therapeutic use; Random Allocation
• ISSN: 0160-2446
• DOI: 10.1097/00005344-198706110-00040

The role of felodipine, a new calcium antagonist, in monotherapy for mild and moderate hypertension was investigated in a placebo-controlled double-blind study of 109 patients from 13 centres. The patients were randomised in a double-blind fashion to receive felodipine, 2.5 mg b.i.d. (32 patients), 5 mg b.i.d. (30 patients), 10 mg b.i.d. (24 patients), or placebo (23 patients). Two hours after the first tablet was administered, there was a reduction in systolic and diastolic blood pressure, both supine (p less than 0.05) and standing (p less than 0.001), that was significantly correlated with dose. Three and 8 weeks later, 2 h after dosage, this correlation was still apparent in both supine and standing blood pressure (p less than 0.001). One week after randomisation, at 12 hours after administration there was a significant correlation with dose in the standing systolic (p less than 0.05) and diastolic (p less than 0.01) blood pressure. After 8 weeks therapy, a significant correlation with dose occurred in both supine and standing systolic (p less than 0.05) and diastolic (p less than 0.01) blood pressure 12 h after therapy. The proportion of patients completing the study who achieved a supine diastolic blood pressure of 90 mm Hg or less after 8 weeks therapy at 2 h after dosage was 9% on placebo, 67% on felodipine 2.5 mg b.i.d., 57% on felodipine 5 mg b.i.d., and 92% on felodipine 10 mg b.i.d. Felodipine was generally well tolerated although 10 patients on the highest dose withdrew due to adverse experiences. Plasma felodipine levels were significantly correlated with dose.