For management of patients with endoscopically proven erosive gastritis, AD-203 (the novel sustained-release formulation of rebamipide 150 mg) administered twice daily demonstrated non-inferiority to rebamipide 100 mg administered thrice daily, as per the findings of phase 3 randomized clinical trial published in Gut Liver.

Gwang Ha Kim et al. undertook this multicenter, noninferiority, double-blind, active control study to investigate the efficacy and safety of the mucoprotective drug rebamipide 100 mg and its novel formulation, AD-203 to treat 473 erosive gastritis patients.

Participants were randomly segregated into either AD-203 twice daily or rebamipide 100 mg thrice daily for two weeks. The intention-to-treat (ITT) assessment incorporated 454 people (AD-203, n=229; rebamipide 100 mg, n=225), and the per-protocol (PP) assessment incorporated 439 people (AD-203, n=224; rebamipide 100 mg, n=215).

Erosion improvement rate was the major outcome ascertained while cure rates of edema and  erosion, and improvement rates of gastrointestinal symptoms, redness, and hemorrhage were the  secondary outcomes ascertained. Assessment of drug-linked noxious events was also done.

The erosion improvement rates (posttreatment) in AD-203-treated and rebamipide 100 mg-treated patients as per ITT and PP analysis is shown in Table 1:

The one-sided 97.5% lower limit for the improvement rate difference between AD-203 group and rebamipide 100 mg group was -4.44% in the PP assessment and -4.01% in the ITT assessment.

In terms of secondary outcomes, the study groups did not considerably differ in both ITT and PP evaluations. Notably, adverse events were reported in 24 and 20 people in AD-203 and  rebamipide groups respectively. However, no serious adverse drug reactions were witnessed. Both the groups showed  a comparable rate of adverse events.

With its excellent safety and efficacy profile, AD-203 appears to be a promising therapeutic choice to treat gastritis and facilitate convenience and adherence by minimizing the administration frequency, concluded the study authors.