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

Abstract

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 (R) SR (rebamipide 150 mg) and Axid (R) (nizatidine 150 mg) combination therapy with the sole administration of Axid (R) 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.