• J Chin Med Assoc · Jan 2021

    Randomized Controlled Trial Comparative Study

    Omeprazole versus famotidine for the prevention of gastroduodenal injury in high-risk users of low-dose aspirin - a randomized controlled trial.

    • Zhi-Fu Tseng, Ping-I Hsu, Nan-Jing Peng, Sung-Shuo Kao, Feng-Woei Tsay, Jin-Shiung Cheng, Wen-Chi Chen, Kun-Feng Tsai, Sheng-Yeh Tang, Seng-Kee Chuah, and Chang-Bih Shie.
    • Division of Gastroenterology and Hepatology, Department of Medicine, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan, ROC.
    • J Chin Med Assoc. 2021 Jan 1; 84 (1): 19-24.

    BackgroundLow-dose aspirin is widely used in the prevention of cardiovascular diseases. However, the use of aspirin is associated with an increased risk of gastrointestinal injury.MethodsLow-dose aspirin users with a history of peptic ulcers who did not have gastroduodenal mucosal breaks at initial endoscopy were randomly assigned to receive famotidine (20 mg bid) or omeprazole (20 mg qd) for 6 months. Follow-up endoscopy was performed at the end of the sixth month and whenever epigastric discomfort, hematemesis, or melena occurred. The primary end point was the occurrence of gastroduodenal mucosal breaks. The secondary end points were (1) the occurrence of gastroduodenal ulcers and (2) the occurrence of gastroduodenal bleeding.ResultBetween November 2013 and June 2018, 170 patients were randomly assigned to receive either famotidine (n = 84) or omeprazole (n = 86). The incidence of gastroduodenal mucosal breaks was 33.8% among the patients receiving famotidine, and 19.8% among those receiving omeprazole (95% CI: 0.4%-27.5%; p = 0.045). The two patient groups had comparable incidence rates of gastroduodenal ulcers (20.0% vs 9.8%; p = 0.071), and gastroduodenal bleeding (2.5% vs 0%; p = 0.243). Multivariate analysis showed that use of the proton pump inhibitor was an independent protective factor (odds ratio: 0.47; 95% CI: 0.23-0.99; p = 0.047), and that smoking was a risk factor for mucosal breaks (odds ratio: 3.84; 95% CI: 1.52-9.71; p = 0.004).ConclusionProton pump inhibitor was superior to histamine-2 receptor antagonist in the prevention of gastroduodenal mucosal breaks in high-risk users of low-dose aspirin, and smoking was an independent risk factor for developing gastroduodenal mucosal breaks.Copyright © 2020, the Chinese Medical Association.

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