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Published on: June 29, 2019
Comprehensive Benefit Evaluation and Clinical Decision-Making After 4-week Cinitapride Treatment on Functional
Tao Bai1, Dan Zhou1, Jie Chen2
1Division of Gastroenterology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
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).
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