A collaborative, double-blind randomized study of cetiedil citrate in sickle cell crisis.
We have recently completed a double-blind, placebo-controlled, noncrossover study, the goal of which was to determine whether cetiedil citrate (cetiedil) could affect the course of vaso-occlusive crises in sickle cell disease. Patients, who presented to the emergency room at least 4 but no more than 24 hours after the onset of a painful vasoocclusive crisis severe enough to require hospitalization, were considered candidates for the study. Each patient received either placebo or cetiedil at one of the following three dosages: 0.2, 0.3, or 0.4 mg/kg body weight. The assigned drug dosage was given as a 30 minute intravenous infusion every 8 hours for 4 consecutive days. A total of 67 patients was enrolled in the study. Cetiedil, at its highest dosage (0.4 mg/kg body weight), was found to be significantly superior to placebo both in reducing the number of painful sites present on all 4 treatment days and in shortening the total time in crisis. No serious adverse reactions were observed during the course of the study. We conclude that cetiedil, given at a dosage of 0.4 mg/kg body weight, is therapeutically advantageous for sickle cell crisis.
D000293:Adolescent; D000328:Adult; D000755:Anemia, Sickle Cell / Q000188:drug therapy*; D001381:Azepines / Q000627:therapeutic use*; D002648:Child; D002986:Clinical Trials as Topic; D004311:Double-Blind Method; D005260:Female; D006441:Hemoglobin A / Q000032:analysis; D006450:Hemoglobin SC Disease / Q000188:drug therapy; D006801:Humans; D008297:Male; D008875:Middle Aged; D010146:Pain; D011897:Random Allocation; D013789:Thalassemia / Q000188:drug therapy; D013997:Time Factors
D001381:Azepines; C006955:cetiedil; D006441:Hemoglobin A