Gut Liver.  2016 Nov;10(6):917-924. 10.5009/gnl15486.

Limited Effect of Rebamipide in Addition to Proton Pump Inhibitor (PPI) in the Treatment of Post-Endoscopic Submucosal Dissection Gastric Ulcers: A Randomized Controlled Trial Comparing PPI Plus Rebamipide Combination Therapy with PPI Monotherapy

• Nakamura K
• Ihara E
• Akiho H
• Akahoshi K
• Harada N
• Ochiai T
• Nakamura N
• Ogino H
• Iwasa T
• Aso A
• Iboshi Y
• Takayanagi R

• KMID: 2412097
• DOI: http://doi.org/10.5009/gnl15486

Abstract

BACKGROUND/AIMS
The ability of endoscopic submucosal dissection (ESD) to resect large early gastric cancers (EGCs) results in the need to treat large artificial gastric ulcers. This study assessed whether the combination therapy of rebamipide plus a proton pump inhibitor (PPI) offered benefits over PPI monotherapy.
METHODS
In this prospective, randomized, multicenter, open-label, and comparative study, patients who had undergone ESD for EGC or gastric adenoma were randomized into groups receiving either rabeprazole monotherapy (10 mg/day, n=64) or a combination of rabeprazole plus rebamipide (300 mg/day, n=66). The Scar stage (S stage) ratio after treatment was compared, and factors independently associated with ulcer healing were identified by using multivariate analyses.
RESULTS
The S stage rates at 4 and 8 weeks were similar in the two groups, even in the subgroups of patients with large amounts of tissue resected and regardless of CYP2C19 genotype. Independent factors for ulcer healing were circumferential location of the tumor and resected tissue size; the type of treatment did not affect ulcer healing.
CONCLUSIONS
Combination therapy with rebamipide and PPI had limited benefits compared with PPI monotherapy in the treatment of post-ESD gastric ulcer (UMIN Clinical Trials Registry, UMIN000007435).

Keyword

Stomach ulcer; Therapeutics; Endoscopy; Antiulcer agents; Proton pump inhibitors

MeSH Terms

Adenoma/surgery
Aged
Alanine/administration & dosage/*analogs & derivatives
Anti-Ulcer Agents/*administration & dosage
Drug Therapy, Combination
Endoscopic Mucosal Resection/adverse effects
Female
Gastric Mucosa/surgery
Humans
Male
Middle Aged
Postoperative Complications/*drug therapy/etiology
Prospective Studies
Proton Pump Inhibitors/*administration & dosage
Quinolones/*administration & dosage
Rabeprazole/*administration & dosage
Stomach Neoplasms/surgery
Stomach Ulcer/*drug therapy/etiology
Treatment Outcome
Anti-Ulcer Agents
Proton Pump Inhibitors
Quinolones
Rabeprazole
Alanine