Controlled multicenter double-blind trial of nicardipine in the treatment of primary Raynaud phenomenon. French Cooperative Multicenter Group for Raynaud Phenomenon, Paris, France

Abstract

A total of 69 patients with primary Raynaud phenomenon were included in a multicenter, randomized, double-blind, crossover, placebo-controlled trial to assess the efficacy of nicardipine, a new calcium channel blocker. The trial data were combined with a meteorological survey. Nicardipine significantly (p = 0.02) reduced the number of crises of Raynaud phenomenon but had no significant effect on the intensity of the crises. Mean overall improvement, assessed on a linear visual analog scale, was 21% (p = 0.018), but results for the cold-reactive hyperemia test were not significantly altered after nicardipine treatment. All side effects were mild, and their frequency only differed significantly (p less than 0.05) from that of placebo for edema and headache.