Nicardipine for the treatment of Raynaud's phenomena: a double blind crossover trial of a new calcium entry blocker.
Fifteen patients with Raynaud's phenomenon [systemic lupus erythematosus (6), progressive systemic sclerosis (8) and rheumatoid arthritis (1)] and 12 patients with Raynaud's disease participated in a parallel, 4-week/arm, double blind, crossover study of nicardipine, an experimental calcium channel blocker. Nicardipine significantly improved pain (p = 0.03), decreased number of Raynaud's attacks (p less than 0.03), and was preferred over placebo (p less than 0.05) in the patients with Raynaud's disease, but showed an effect only in the number of attacks (p = 0.049) among the group with Raynaud's phenomenon. Plethysmography showed no drug effects. One patient discontinued the trial after developing headaches while taking placebo. Nonlimiting toxicity occurred more commonly with drug than placebo (15 vs 9 times, p less than 0.05). Our study demonstrated that nicardipine improves symptoms in Raynaud's disease, but is not effective in Raynaud's phenomenon.
Rupp
P A
PA
University of Iowa Hospitals and Clinics, Department of Internal Medicine, Iowa City.
Mellinger
S
S
Kohler
J
J
Dorsey
J K
JK
Furst
D E
DE
D001172:Arthritis, Rheumatoid / Q000503:physiopathology; D002986:Clinical Trials as Topic; D004311:Double-Blind Method; D004341:Drug Evaluation; D005260:Female; D006439:Hemodynamics; D006801:Humans; D008180:Lupus Erythematosus, Systemic / Q000503:physiopathology; D008297:Male; D009529:Nicardipine / Q000009:adverse effects / Q000627:therapeutic use*; D010991:Plethysmography; D011897:Random Allocation; D011928:Raynaud Disease / Q000188:drug therapy* / Q000503:physiopathology; D012595:Scleroderma, Systemic / Q000503:physiopathology
D009529:Nicardipine