Efficacy and safety of rebamipide/nizatidine in patients with erosive gastritis: A randomized, multicenter, phase 4 study.

Autor:	Kang D; Department of Internal Medicine, Seoul St. Mary's Hospital, The Catholic University of Korea, Seoul 06591, South Korea., Choi MG; Department of Internal Medicine, Seoul St. Mary's Hospital, The Catholic University of Korea, Seoul 06591, South Korea. choim@catholic.ac.kr., Shim KN; Department of Internal Medicine, Ewha Womans University Seoul Hospital, Gastroenterology and Hepatology Center, Seoul 07985, South Korea., Jung HK; Department of Internal Medicine, Ewha Womans University Mokdong Hospital, Seoul 07985, South Korea., Nam SJ; Department of Internal Medicine, Kangwon National University School of Medicine, Chuncheon 24289, South Korea., Park JH; Department of Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul 03181, South Korea., Kim SG; Department of Internal Medicine and Liver Research Institute, Seoul National University Hospital, Seoul 03080, South Korea., Kim NH; Department of Internal Medicine, Ilsan Paik Hospital, Inje University College of Medicine, Goyang 10380, South Korea., Hong SJ; Department of Internal Medicine, Digestive Disease Center, Soonchunhyang University Bucheon Hospital, Bucheon 31538, South Korea., Jeon TJ; Department of Internal Medicine, Inje University College of Medicine, Sanggye Paik Hospital, Seoul 01757, South Korea., Chung JI; Department of Gastroenterology, Sahmyook Medical Center, Seoul 02500, South Korea., Lee HL; Department of Internal Medicine, Hanyang University College of Medicine, Seoul 04763, South Korea., Lee JY; Department of Internal Medicine, Keimyung University School of Medicine, Daegu 42601, South Korea., Kim TO; Department of Internal Medicine, Inje University Haeundae Paik Hospital, Inje University College of Medicine, Busan 48108, South Korea., Lee CM; Department of Internal Medicine, Gyeongsang National University School of Medicine, Gyeongsang National University Hospital, Jinju 52727, South Korea., Kim SM; Department of Internal Medicine, Konyang University Hospital, Daejeon 35365, South Korea., Kim JH; Gastroenterology Center, Konkuk University Medical Center, Seoul 05030, South Korea., Kim JE; Department of Gastroenterology, Seoul Medical Center, Seoul 02053, South Korea., Moon JS; Department of Gastroenterology, Inje University Busan Paik Hospital, Busan 47392, South Korea., Kim HD; Department of Gastroenterology, St. Carollo Hospital, Sooncheon 57931, South Korea., Lee WS; Division of Gastroenterology, Department of Internal Medicine, Chonnam Medical University Hwasun Hospital, Hwasun 58128, South Korea., Park HJ; Division of Gastroenterology, Department of Internal Medicine, Yonsei University Wonju College of Medicine, Wonju 26426, South Korea.
Jazyk:	angličtina
Zdroj:	World journal of gastroenterology [World J Gastroenterol] 2024 Dec 28; Vol. 30 (48), pp. 5152-5161.
DOI:	10.3748/wjg.v30.i48.5152
Abstrakt:	Background: For the treatment of gastritis, rebamipide, a mucoprotective agent, and nizatidine, a gastric acid suppressant, are commonly employed individually. Aim: To compare the efficacy of Mucotra ® SR (rebamipide 150 mg) and Axid ® (nizatidine 150 mg) combination therapy with the sole administration of Axid ® in managing erosive gastritis. Methods: A total of 260 patients diagnosed with endoscopically confirmed erosive gastritis were enrolled in this open-label, multicenter, randomized, phase 4 clinical trial, allocating them into two groups: Rebamipide/nizatidine combination twice daily vs nizatidine twice daily for 2 weeks. The full-analysis set analysis encompassed 239 patients (rebamipide/nizatidine, n = 121; nizatidine, n = 118), while the per-protocol analysis included 218 patients ( n = 110 vs 108). Post-treatment assessments comprised primary (erosion improvement rate) and secondary (erosion and edema cure rates, erythema improvement rates, hemorrhage, and gastrointestinal symptoms) endpoints. Furthermore, drug-related adverse effects were evaluated. Results: Primary efficacy assessment showed a statistically significant improvement rate in mucosal erosions in the combination group compared to the control group in the full-analysis set (rebamipide/nizatidine 62.0%, nizatidine 49.2%, P = 0.046), with a similar trend noted in the per-protocol analysis (62.7% vs 50.0%, P = 0.058). Both groups were effective in curing erosion and edema and improvement of bleeding, erythema, and gastrointestinal symptoms, whereas no inter-group differences were noted. When confined to the participants with gastritis symptoms, improvement of erosion was more optimal in the combination group (63.0% vs 49.5%, P = 0.046). No adverse events related to the drugs were observed. Conclusion: Rebamipide/nizatidine combination is effective in treatment of erosive gastritis. Competing Interests: Conflict-of-interest statement: All the authors report no relevant conflicts of interest for this article. (©The Author(s) 2024. Published by Baishideng Publishing Group Inc. All rights reserved.)
Databáze:	MEDLINE
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