Two year maintenance treatment of duodenal ulcer disease with ranitidine 150 mg: a prospective multicentre randomised study. GEMUD (Groupe d'Etude de la Maladie Ulcéreuse Duodénale).
Maintenance treatment of duodenal ulcer (DU) with ranitidine 150 mg/day was compared with placebo in a two year prospective multicentre randomised study. Three hundred and ninety nine patients were included (mean age: 44.7 years, M/F ratio = 2.47/1; 37.6% of smokers) in placebo (n = 202) and ranitidine (n = 197) groups. Efficacy was assessed by the length of time to the first ulcer pain attack (with or without endoscopic confirmation) or DU complication. One hundred and fourteen patients of 399 (28.6%) had incomplete follow up. Actuarial survival curves of patients without ulcer pain (26 and 53% at two years in placebo and ranitidine groups, respectively) were significantly different (p < 0.0001). Endoscopies were performed depending on physicians' decision (mainly where there was severe pain or complication). Patients without relapses from endoscopy were more frequent in the ranitidine group (83%) than in the placebo group (47%, p < 0.0001). A greater incidence of complications, mainly bleeding, was also seen in the placebo group (13 complications v two in the ranitidine group, p < 0.002). No factor predicting DU relapse was identified. No important side effect was encountered. Ranitidine 150 mg/day is effective and well tolerated in preventing ulcer pain attacks and DU complications for up to two years.
Ruszniewski
P
P
Department of Gastroenterology, Hôpital Beaujon, Clichy, France.
Slama
A
A
Pappo
M
M
Mignon
M
M
D000328:Adult; D004311:Double-Blind Method; D004381:Duodenal Ulcer / Q000150:complications / Q000517:prevention & control*; D005260:Female; D006801:Humans; D008297:Male; D010146:Pain / Q000517:prevention & control; D010349:Patient Compliance; D010438:Peptic Ulcer Hemorrhage; D011446:Prospective Studies; D011899:Ranitidine / Q000627:therapeutic use*; D013997:Time Factors
D011899:Ranitidine