A Double-blind, Randomized, Multicenter Clinical Trial Investigating the Efficacy and Safety of Esomeprazole Single Therapy Versus Mosapride and Esomeprazole Combined Therapy in Patients with Esophageal Reflux Disease

Abstract

Background/aims: We aim to evaluate the efficacy and safety of combination therapy in erosive reflux disease (ERD) patients by comparing endoscopic healing rates according to the Los Angeles classification for esomeprazole alone, and esomeprazole plus mosapride.

Methods: A total of 116 ERD patients were randomized to receive esomeprazole 40 mg once daily plus mosapride 5 mg 3 times daily (E+M group), or esomeprazole plus placebo (E only group) for 8 weeks. Patients recorded gastroesophageal reflux disease (GERD) symptom questionnaire at weeks 4 and 8. The primary endpoint was the endoscopic healing rate of ERD after 8 weeks of treatment.

Results: Endoscopic healing rates according to the Los Angeles classification was 32 (66.7%) in the E+M group and 26 (60.5%) in the E only group, but there was no statistically significant difference between the groups. Only at 4 weeks, the total GERD symptom score changes relative to the baseline significantly improved in the E+M group than that of the E only group (-13.4 ± 14.7 vs -8.0 ± 12.3, P = 0.041), and upper abdominal pain and belching score changes showed significantly improved in the E+M group than that of the E only group (P = 0.018 and P = 0.013, respectively).

Conclusions: The combination of a proton pump inhibitor with mosapride shows a tendency for upper abdominal pain, belching, and total GERD symptoms scores to improve more rapidly. This suggests that combination therapy with esomeprazole and mosapride will be useful for rapid improvement of specific GERD symptoms, such as upper abdominal pain and belching in ERD patients.

Keywords: Gastroesophageal reflux; Gastrointestinal motility; Proton pump inhibitors; Therapeutics.

Figure 1

Subject disposition and analysis population of the study. E+M group, esomeprazole 40 mg once daily plus mosapride 5 mg 3 times daily for 8 weeks; E only group, esomeprazole 40 mg once daily plus placebo 5 mg 3 times daily for 8 weeks.

Figure 2

Improved rates in total gastroesophageal reflux disease symptoms after 4 and 8 weeks of medication (intention-to-treat analysis). E+M group, esomeprazole 40 mg once daily plus mosapride 5 mg 3 times daily for 8 weeks; E only group, esomeprazole 40 mg once daily plus placebo 5 mg 3 times daily for 8 weeks.