Efficacy and Safety of Rebamipide versus Its New Formulation, AD-203, in Patients with Erosive Gastritis: A Randomized, Double-Blind, Active Control, Noninferiority, Multicenter, Phase 3 Study

• Published in: Gut and liver Vol. 15; no. 6; pp. 841 - 850
• Main Authors: Gwang Ha Kim, Hang Lak Lee, Moon Kyung Joo, Hong Jun Park, Sung Woo Jung, Ok-jae Lee, Hyungkil Kim, Hoon Jai Chun, Soo Teik Lee, Ji Won Kim, Han Ho Jeon, Il-kwun Chung, Hyun-soo Kim, Dong Ho Lee, Kyoung-oh Kim, Yun Jeong Lim, Seun-ja Park, Soo-jeong Cho, Byung-wook Kim, Kwang Hyun Ko, Seong Woo Jeon, Jae Gyu Kim, In-kyung Sung, Tae Nyeun Kim, Jae Kyu Sung, Jong-jae Park
• Format: Journal Article
• Language: Korean
• Published: 대한소화기기능성질환·운동학회 30.11.2021
• Subjects: Adverse drug reaction; Gastritis; Intention-to-treat analysis; Phase III clinical trial; Rebamipide
• ISSN: 1976-2283

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. (Gut Liver 2021;15:841-850)