Evaluation of cinitapride's efficacy and safety in treating functional dyspepsia with overlapping symptoms: a real-world study in Chinese healthcare settings.

Objective: Cinitapride, a gastrointestinal prokinetic, is commonly used for treating functional dyspepsia. However, large-scale, real-world data on its efficacy, especially in patients with overlapping symptoms, are limited. The aim of this study was to evaluate the clinical effectiveness and safety of cinitapride in Chinese patients with functional dyspepsia, including those with overlapping symptoms, in a real-world setting.

Methods: In this single-arm, prospective, multicentric study, 1,012 Chinese outpatients with functional dyspepsia and functional dyspepsia overlapping with gastroesophageal reflux disease, irritable bowel syndrome, and/or functional constipation were treated with cinitapride (1 mg t.i.d.) from May 2019 to March 2021. Symptom improvement was assessed at weeks 2 and 4, with adverse events recorded.

Results: At weeks 2 and 4, the overall symptom improvement rate was 62.4 and 90.9%, respectively. Subgroup improvement rates were as follows: functional dyspepsia-gastroesophageal reflux disease, 86.8%; functional dyspepsia-irritable bowel syndrome, 96.2%; functional dyspepsia-functional constipation, 91.7%; and functional dyspepsia-gastroesophageal reflux disease-irritable bowel syndrome, 67.6%. functional dyspepsia patients showed statistically significantly higher improvement than those with overlapping symptoms at weeks 2 (p=0.018) and 4 (p=0.009). The dyspepsia symptom score decreased by 51.0% at week 2 and 74.4% at week 4 (p<0.001). The most common adverse event was asymptomatic electrocardiogram abnormalities (n=8).

Conclusion: Cinitapride is effective and well-tolerated in treating functional dyspepsia and functional dyspepsia-overlapping gastroesophageal reflux disease, irritable bowel syndrome, and functional constipation in Chinese patients.