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KMID : 1188320210150060841
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Gut and Liver
2021 Volume.15 No. 6 p.841 ~ p.850
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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
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Kim Gwang-Ha
Lee Hang-Lak
Joo Moon-Kyung
Park Hong-Jun
Jung Sung-Woo
Lee Ok-Jae
Kim Hyung-Kil
Chun Hoon-Jai
Lee Soo-Teik
Kim Ji-Won
Jeon Han-Ho
Chung Il-Kwun
Kim Hyun-Soo
Lee Dong-Ho
Kim Kyoung-Oh
Lim Yun-Jeong
Park Seun-Ja
Cho Soo-Jeong
Kim Byung-Wook
Ko Kwang-Hyun
Jeon Seong-Woo
Kim Jae-Gyu
Sung In-Kyung
Kim Tae-Nyeun
Sung Jae-Kyu
Park Jong-Jae
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Abstract
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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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KEYWORD
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Adverse drug reaction, Gastritis, Intention-to-treat analysis, Phase III clinical trial, Rebamipide
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