Felodipine--a new vasodilator, in addition to beta-receptor blockade in hypertension.

In a double-blind, cross-over trial, 10 men with primary hypertension, not adequately controlled with a beta-blocker alone, were also given felodipine or placebo for periods of one week. Placebo was administered single-blind for 2 weeks and 1 week, respectively, before randomization and between treatments. The dose of felodipine ranged from 6.25 mg to 25 mg. The addition of felodipine resulted in a pronounced (20%), statistically significant reduction in blood pressure (BP) and a small but significant increase in heart rate (HR). The effects were seen within 1-2 h and were maximal after 3-4 h. During steady state treatment the duration of BP reduction was at least 12 h. No orthostatic reaction was seen. There was a significant correlation between the plasma concentration of felodipine and change in BP. The most frequently reported side-effects were headache and ankle oedema, the latter probably being due to pronounced pre-capillary vasodilatation. There was no weight increase and thus no indication of general water retention. No clinically significant change in laboratory variables and no influence on the P-Q time were seen. Thus, felodipine in combination with a beta-blocker seems to be a useful addition to the treatment of hypertensive patients whose BP is not adequately controlled with a beta-blocker alone.

RCT Entities:   Population Interventions Outcomes