Gut Liver.
2021 Nov;15(6):841-850. 10.5009/gnl20338.
Efficacy and Safety of Rebamipide versus Its New Formulation, AD-203, in Patients with Erosive Gastritis: A Randomized, DoubleBlind, Active Control, Noninferiority, Multicenter, Phase 3 Study
- Kim GH
1 - Lee HL2
- Joo MK3
- Park HJ4
- Jung SW5
- Lee OJ6
- Kim H7
- Chun HJ8
- Lee ST9
- Kim JW10
- Jeon HH11
- Chung IK12
- Kim HS13
- Lee DH14
- Kim KO15
- Lim YJ16
- Park SJ17
- Cho SJ18
- Kim BW19
- Ko KH20
- Jeon SW21
- Kim JG22
- Sung IK23
- Kim TN24
- Sung JK25
- Park JJ3
- Affiliations
-
- 1Department of Internal Medicine, Pusan National University College of Medicine, and Biomedical Research Institute, Pusan National University Hospital, Busan, Korea.
- 2Department of Internal Medicine, Hanyang University Hospital, Seoul, Korea.
- 3Division of Gastroenterology, Department of Internal Medicine, Korea University Guro Hospital, Seoul, Korea.
- 4Department of Internal Medicine, Yonsei University Wonju College of Medicine, Wonju, Korea.
- 5Division of Gastroenterology, Department of Internal Medicine, Korea University Ansan Hospital, Ansan, Korea.
- 6Department of Internal Medicine, Gyeongsang National University College of Medicine, Jinju, Korea.
- 7Department of Internal Medicine, Inha University School of Medicine, Incheon, Korea.
- 8Division of Gastroenterology and Hepatology, Department of Internal Medicine, Institute of Gastrointestinal Medical Instrument Research, Korea University College of Medicine, Seoul, Korea.
- 9Department of Internal Medicine, Jeonbuk National University Hospital, Jeonju, Korea.
- 10Department of Internal Medicine, SMG-SNU Boramae Medical Center, Seoul National University of College of Medicine, Seoul, Korea.
- 11Department of Internal Medicine, National Health Insurance Service Ilsan Hospital, Goyang, Korea.
- 12Department of Internal Medicine, Soonchunhyang University College of Medicine, Cheonan, Korea.
- 13Department of Internal Medicine, Chonnam National University Hospital, Gwangju, Korea.
- 14Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea.
- 15Department of Internal Medicine, Gachon University Gil Medical Center, Incheon, Korea.
- 16Department of Internal Medicine, Dongguk University College of Medicine, Seoul, Korea.
- 17Department of Internal Medicine, Kosin University Gospel Hospital, Kosin University College of Medicine, Busan, Korea.
- 18Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea.
- 19Department of Internal Medicine, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.
- 20Department of Internal Medicine, CHA Bundang Medical Center, CHA University, Seongnam, Korea.
- 21Department of Internal Medicine, School of Medicine, Kyungpook National University, Daegu, Korea.
- 22Department of Internal Medicine, Chung-Ang University College of Medicine, Seoul, Korea.
- 23Department of Internal Medicine, Konkuk University School of Medicine, Seoul, Korea.
- 24Department of Internal Medicine, Yeungnam University College of Medicine, Daegu, Korea.
- 25Department of Internal Medicine, Chungnam National University College of Medicine, Daejeon, Korea.
- KMID: 2522345
- DOI: http://doi.org/10.5009/gnl20338
Abstract
- Background/Aims
The mucoprotective drug rebamipide is used to treat gastritis and peptic ulcers. We compared the efficacy of Mucosta Ⓡ (rebamipide 100 mg) and its new formulation, AD-203 (rebamipide 150 mg), in treating erosive gastritis.
Methods
This double-blind, active control, noninferiority, multicenter, phase 3 clinical trial randomly assigned 475 patients with endoscopically proven erosive gastritis to two groups: AD-203 twice daily or Mucosta Ⓡ thrice daily for 2 weeks. The intention-to-treat (ITT) analysis included 454 patients (AD-203, n=229; Mucosta Ⓡ , n=225), and the per-protocol (PP) analysis included 439 patients (AD-203, n=224; Mucosta Ⓡ , n=215). The posttreatment assessments included the primary (erosion improvement rate) and secondary endpoints (erosion and edema cure rates; improvement rates of redness, hemorrhage, and gastrointestinal symptoms). Drug-related adverse events were evaluated.
Results
According to the ITT analysis, the erosion improvement rates (posttreatment) in AD-203-treated and Mucosta Ⓡ -treated patients were 39.7% and 43.8%, respectively. According to the PP analysis, the erosion improvement rates (posttreatment) in AD-203-treated and Mucosta Ⓡ -treated patients were 39.3% and 43.7%, respectively. The one-sided 97.5% lower limit for the improvement rate difference between the study groups was −4.01% (95% confidence interval [CI], –13.09% to 5.06%) in the ITT analysis and −4.44% (95% CI, –13.65% to 4.78%) in the PP analysis. The groups did not significantly differ in the secondary endpoints in either analysis. Twenty-four AD-203-treated and 20 Mucosta Ⓡ -treated patients reported adverse events but no serious adverse drug reactions; both groups presented similar adverse event rates.
Conclusions
The new formulation of rebamipide 150 mg (AD-203) twice daily was not inferior to rebamipide 100 mg (Mucosta Ⓡ ) thrice daily. Both formulations showed a similar efficacy in treating erosive gastritis.
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