OBJECTIVES: To compare the healing rates of acute duodenal ulcer in patients receivingpantoprazole 40 mg or omeprazole 20 mg once daily and to assess drug tolerance. DESIGN: Randomized, double-blind study evaluating patients with healed duodenal ulcer on endoscopy after 2 weeks of treatment and patients unhealed at 2 and after 4 weeks of treatment. SETTING: Hospital or private gastroenterology practice outpatients. PATIENTS: Men or women, aged at least 18 years, with one or two duodenal ulcers. Patients with ulcer complications or with other significant acid-related disease were excluded. A total of 270 patients entered the study, of whom 255 were included in the per-protocol analysis. RESULTS: The primary measure of efficacy was the healing rates of duodenal ulcers. Complete healing of ulcers was observed in 88 (71%) of the 124 patients in the pantoprazole group and in 85 (65%) of the 131 patients in the omeprazole group after 2 weeks of treatment. The cumulative healing rates after 4 weeks were 118 (95%) out of 124 and 117 (89%) out of 131 patients, respectively. There was no significant difference between treatment groups with respect to either healing rates or freedom from ulcer pain at 2 weeks. Both treatments were well tolerated: only 10 and 11 patients in the pantoprazole and omeprazole groups, respectively, reported adverse events. Diarrhoea was reported by two patients in each group. CONCLUSIONS:Pantoprazole 40 mg daily and omeprazole 20 mg daily are equally effective in inducing ulcer healing.
RCT Entities:
OBJECTIVES: To compare the healing rates of acute duodenal ulcer in patients receiving pantoprazole 40 mg or omeprazole 20 mg once daily and to assess drug tolerance. DESIGN: Randomized, double-blind study evaluating patients with healed duodenal ulcer on endoscopy after 2 weeks of treatment and patients unhealed at 2 and after 4 weeks of treatment. SETTING: Hospital or private gastroenterology practice outpatients. PATIENTS: Men or women, aged at least 18 years, with one or two duodenal ulcers. Patients with ulcer complications or with other significant acid-related disease were excluded. A total of 270 patients entered the study, of whom 255 were included in the per-protocol analysis. RESULTS: The primary measure of efficacy was the healing rates of duodenal ulcers. Complete healing of ulcers was observed in 88 (71%) of the 124 patients in the pantoprazole group and in 85 (65%) of the 131 patients in the omeprazole group after 2 weeks of treatment. The cumulative healing rates after 4 weeks were 118 (95%) out of 124 and 117 (89%) out of 131 patients, respectively. There was no significant difference between treatment groups with respect to either healing rates or freedom from ulcer pain at 2 weeks. Both treatments were well tolerated: only 10 and 11 patients in the pantoprazole and omeprazole groups, respectively, reported adverse events. Diarrhoea was reported by two patients in each group. CONCLUSIONS:Pantoprazole 40 mg daily and omeprazole 20 mg daily are equally effective in inducing ulcer healing.