Comparison of Efficacy and Safety between Mosapride and Acotiamide for Japanese patients with Functional Dyspepsia
Background: 5-HT4 agonists (mosapride) and acetylcholine esterase inhibitor (acotiamide) are prokinetics used to treat functional dyspepsia (FD). However, to date, there has been no direct comparative study between them. The aim of this study was to compare the drugs’ efficacy and safety and to determine their predictive biomarkers. Methods: The present study was a prospective, randomized, open-labeled, and crossover trial in Japanese FD patients. FD was diagnosed using Rome IV. We performed upper gastrointestinal (GI) endoscopy, GI symptom rating scale, and 8-item Short-Form Health Survey to evaluate the presence of GI disorders, GI symptoms, and quality of life (QOL), respectively. Responders were defined when reporting at least a 40% improvement of the GSRS scores from their baseline. Results: In total, 60 Japanese FD patients were randomly assigned to the acotiamide preceding group (n = 30) or mosapride preceding group (n = 30), and 51 patients were finally analyzed. Following treatment with both mosapride and acotiamide, GI symptoms and QOL scores improved significantly. The responder rates of mosapride and acotiamide were 37% and 33%, respectively. No severe adverse clinical event developed. The prevalence of H. pylori eradication history was significantly lower in the mosapride responder group than in the nonresponder group (45.9% vs. 14.2%, p = 0.03). Discussion: Mosapride and acotiamide had similar effects on GI symptoms in FD patients in the absence of severe adverse events. H. pylori infection might impact in the pathogenesis of functional dyspepsia. Further investigation is needed to clarify the difference between mosapride and acotiamide.