Felodipine ER formulation in the treatment of mild hypertension: efficacy and tolerability vs placebo.

Abstract

1. Felodipine is a new calcium‐antagonist dihydropyridine derivative with a high degree of selectivity for smooth muscle of arteriolar resistance vessels, as opposed to cardiac cells. 2. In this double‐ blind, cross‐over study the antihypertensive efficacy and tolerability of the new extended release (ER) formulation of felodipine 10 mg, once daily, in patients with mild essential hypertension was evaluated. After a 4‐week single‐blind placebo period 28 patients (15 males; mean age 48 +/− 12 years) were randomized to receive felodipine 10 mg ER once daily or placebo for 4 weeks and the alternative treatment for a further 4 weeks. Supine blood pressure and heart rate were measured in the out‐patients department every 2 weeks, 22‐24 h after the last drug administration. 3. Felodipine 10 mg ER induced a significant reduction in blood pressure in comparison with placebo (from 149 +/− 16/97 +/− 6 to 140 +/− 12/89 +/− 6 mm Hg). Heart rate remained unchanged. Seven patients dropped‐out; five during felodipine ER administration and two during placebo. 4. A once daily dose of felodipine ER significantly reduces blood pressure in mild hypertensive patients 22‐24 h after administration. It is well tolerated and the adverse events are related to its pharmacodynamic effects. 1990 The British Pharmacological Society