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.
Gut Liver
; 15(6): 841-850, 2021 11 15.
Article
in En
| MEDLINE
| ID: mdl-33827990
ABSTRACT
Background/Aims:
The mucoprotective drug rebamipide is used to treat gastritis and peptic ulcers. We compared the efficacy of Mucostaâ (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 Mucostaâ thrice daily for 2 weeks. The intention-to-treat (ITT) analysis included 454 patients (AD-203, n=229; Mucostaâ, n=225), and the per-protocol (PP) analysis included 439 patients (AD-203, n=224; Mucostaâ, 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 Mucostaâ-treated patients were 39.7% and 43.8%, respectively. According to the PP analysis, the erosion improvement rates (posttreatment) in AD-203-treated and Mucostaâ-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 Mucostaâ-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 (Mucostaâ) thrice daily. Both formulations showed a similar efficacy in treating erosive gastritis.Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Stomach Ulcer
/
Quinolones
/
Gastritis
Type of study:
Clinical_trials
/
Guideline
Limits:
Humans
Language:
En
Journal:
Gut Liver
Year:
2021
Document type:
Article