Evaluation of the Efficacy and Safety of DW1903 in Patients with Gastritis: A Randomized, Double-Blind, Noninferiority, Multicenter, Phase 3 study
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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, low-dose PPI can be a novel option for treating gastritis (ClinicalTrials.gov Identifier: NCT05163756).
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, low-dose PPI can be a novel option for treating gastritis (ClinicalTrials.gov Identifier: NCT05163756).
참고문헌 (15)
- Son HJ, "Hypersensitivity to acid in ulcer-like functional dyspepsia", Korean J Intern Med, 12, pp.188~192 (1997)
- Samsom M, "Abnormal clearance of exogenous acid and increased acid sensitivity of the proximal duodenum in dyspeptic patients", Gastroenterology, 116, pp.515~520 (1999)
- Lee KJ, "Duodenal implications in the pathophysiology of functional dyspepsia", J Neurogastroenterol Motil, 16, pp.251~257 (2010)
- Kim GH, "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, pp.841~850 (2021)
- Miner PB, "Comparison of gastric pH with omeprazole magnesium 20. 6 mg(Prilosec OTC)o. m. famotidine 10 mg(Pepcid AC)b. d. and famotidine 20mg b. d. over 14 days of treatment", Aliment Pharmacol Ther, 25, pp.103~109 (2007)
- Seol SY, "DA-9601 for erosive gastritis : results of a double-blind placebocontrolled phase III clinical trial", World J Gastroenterol, 10, pp.2379~2382 (2004)
- Shim KN, "The efficacy and safety of irsogladine maleate in nonsteroidal anti-inflammatory drug or aspirin-induced peptic ulcer and gastritis", Korean J Intern Med, 34, pp.1008~1021 (2019)
- Choi YJ, "Evaluation of the efficacy and safety of DA-9601 versus its new formulation, DA-5204, in patients with gastritis : phase III, randomized, doubleblind, non-inferiority study", J Korean Med Sci, 32, pp.1807~1813 (2017)
- Kim JH, "The clinical efficacy of a pure alginate formulation(Lamina G)for controlling symptoms in individuals with reflux symptoms : a randomized clinical study", Gut Liver, 13, pp.642~648 (2019)
- Richter JE, "Efficacy and safety of esomeprazole compared with omeprazole in GERD patients with erosive esophagitis : a randomized controlled trial", Am J Gastroenterol, 96, pp.656~665 (2001)
- Bate CM, "Reflux symptom relief with omeprazole in patients without unequivocal oesophagitis", Aliment Pharmacol Ther, 10, pp.547~555 (1996)
- Chiba N, "Speed of healing and symptom relief in grade II to IV gastroesophageal reflux disease : a meta-analysis", Gastroenterology, 112, pp.1798~1810 (1997)
- Jung HK, "Updated guidelines 2012 for gastroesophageal reflux disease", Korean J Gastroenterol, 60, pp.195~218 (2012)
- Vaezi MF, "Complications of proton pump inhibitor therapy", Gastroenterology, 153, pp.35~48 (2017)
- Hill AB, "The environment and disease : association or causation?", Proc R Soc Med, 58, pp.295~300 (1965)