Evaluation of the Efficacy and Safety of DW1903 in Patients with Gastritis: A Randomized, Double-Blind, Noninferiority, Multicenter, Phase 3 Study

Overview

Journal Gut Liver

Specialty Gastroenterology

Date 2023 Jun 13

PMID 37309193

Authors

Jie-Hyun Kim

Hwoon-Yong Jung

In Kyung Yoo

Seon-Young Park

Jae Gyu Kim

Jae Kyu Sung

Jin Seok Jang

Gab Jin Cheon

Kyoung Oh Kim

Tae Oh Kim

Soo Teik Lee

Kwang Bum Cho

Hoon Jai Chun

Jong-Jae Park

Moo In Park

Jae-Young Jang

Seong Woo Jeon

Jin Woong Cho

Dae Hwan Kang

Gwang Ha Kim

Jae J Kim

Sang Gyun Kim

Nayoung Kim

Yong Chan Lee

Su Jin Hong

Hyun-Soo Kim

Sora Lee

Sang Woo Lee

Affiliations

Soon will be listed here.

Abstract

Background/aims: H2 receptor antagonists (H2RA) have been used to treat gastritis by inhibiting gastric acid. Proton pump inhibitors (PPIs) are more potent acid suppressants than H2RA. However, the efficacy and safety of low-dose PPI for treating gastritis remain unclear. The aim was to investigate the efficacy and safety of low-dose PPI for treating gastritis.

Methods: A double-blind, noninferiority, multicenter, phase 3 clinical trial randomly assigned 476 patients with endoscopic erosive gastritis to a group using esomeprazole 10 mg (DW1903) daily and a group using famotidine 20 mg (DW1903R1) daily for 2 weeks. The full-analysis set included 319 patients (DW1903, n=159; DW1903R1, n=160) and the per-protocol set included 298 patients (DW1903, n=147; DW1903R1, n=151). The primary endpoint (erosion improvement rate) and secondary endpoint (erosion and edema cure rates, improvement rates of hemorrhage, erythema, and symptoms) were assessed after the treatment. Adverse events were compared.

Results: According to the full-analysis set, the erosion improvement rates in the DW1903 and DW1903R1 groups were 59.8% and 58.8%, respectively. According to the per-protocol analysis, the erosion improvement rates in the DW1903 and DW1903R1 groups were 61.9% and 59.6%, respectively. Secondary endpoints were not significantly different between two groups except that the hemorrhagic improvement rate was higher in DW1903 with statistical tendency. The number of adverse events were not statistically different.

Conclusions: DW1903 of a low-dose PPI was not inferior to DW1903R1 of H2RA. Thus, lowdose PPI can be a novel option for treating gastritis (ClinicalTrials.gov Identifier: NCT05163756).

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