Comprehensive Benefit Evaluation and Clinical Decision-Making After 4-week Cinitapride Treatment on Functional Dyspepsia: A Multicenter, Prospective Designed, Real-World Study.

PURPOSE: Functional dyspepsia (FD) is a functional gastrointestinal disorder diagnosed by symptom-based criteria. This study aimed to evaluate the efficacy of 8-week cinitapride treatment in patients with FD and to explore the appropriate clinical decision after 4 weeks of therapy.

METHODS

This real-world, multicenter, prospective study enrolled 1,530 FD patients meeting Rome IV criteria from nearly 100 gastroenterology centers in China between September 2020 and January 2021. A total of 1,313 patients completed the 8-week follow-up. The primary endpoint was the effective remission rate (ERR) of cinitapride from weeks 4 to 8. ANCOVA and Cox regression analyses were performed to adjust for baseline characteristics and identify efficacy predictors.

RESULTS

After covariate adjustment, patients continuing cinitapride during weeks 4-8 showed significantly higher remission rates than nonusers (β = 14.52, t = 2.016, p = 0.044). Cox regression identified younger age, lower BMI, higher education, nonpostprandial distress syndrome (non-PDS) subtype, and both maintenance (HR = 9.18, p < 0.001) and on-demand (HR = 8.54, p < 0.001) regimens as independent predictors of response. In patients under 60 years, the PDS subtype was associated with greater efficacy (HR = 2.00, p = 0.019). Treatment effects were consistent across age groups.

CONCLUSION

Eight weeks of cinitapride treatment significantly improved symptom remission in patients with FD, particularly those under 60 years with the PDS subtype. Response after 4 weeks of therapy may guide individualized decisions on whether to continue or discontinue treatment, with on-demand use showing favorable efficacy and reduced exposure. The Name of the Trial Registry: Clinical efficacy and safety of prokinetic agents as maintenance therapy for functional dyspepsia (FD): a real-world study. The Registration Number of the Trial: https://www.

CLINICALTRIALS: gov/ (ChiCTR2100042166).