European journal of gastroenterology & hepatology · 1995
Double-blind comparison of pantoprazole and omeprazole for the treatment of acute duodenal ulcer.
Клиническое исследованиеСравнительное исследованиеСтатьяМногоцентровое исследованиеРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Beker J A, Bianchi Porro G, Bigard M A, Delle Fave G, Devis G, Gouerou H, Maier C
Аннотация
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.
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.