Impact of itopride on functional dyspepsia symptom progression: a multicenter noninterventional postregistration study

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Background: Functional dyspepsia (FD) is a prevalent condition characterized by symptoms such as postprandial fullness, early satiety, and epigastric pain, which significantly affect daily activities and quality of life. Objectives: This study aimed to assess the effectiveness of itopride hydrochloride, a prokinetic agent, in reducing the severity of these symptoms among patients with FD. Design: In this noninterventional, observational, post-authorization, prospective, multicenter study (without placebo or comparator) 339 patients with FD were treated with itopride and followed over a period of 12 weeks. The study clinical protocol ITO-NPS-01-PMCS-2021 was approved by the Ethical Committee of the University Hospital Brno and Faculty of Medicine, Masaryk University, Brno (ORG No: 100022981/LOC No:100031711), and reported to the Czech State Institute of Drug Control (identifier: 2110140000) following local legislation. Methods: The patients' symptoms were quantified at baseline, 3-6 weeks, and 7-12 weeks using the modified "Leuven Postprandial Distress Scale." Statistical analysis involved the Wilcoxon test, Mann-Whitney test, and Kruskal-Wallis test, focusing on changes in symptom scores and following potential adverse effects (AEs) over time. Results: Itopride hydrochloride treatment resulted in a statistically significant median reduction in symptom severity scores from baseline to the first and second follow-up assessments. The scores decreased by 5 points at the first follow-up and by 8 points at the second follow-up across all FD patient subgroups, regardless of age and gender. The study also observed minimal AEs, with only 2% of patients experiencing mild symptoms. Conclusion: Itopride appears to be a safe and effective treatment for reducing symptom severity in patients with FD. The findings support the use of itopride in clinical settings, providing evidence of its benefit in managing this challenging condition. This study brings additional clinical knowledge from the eastern European population (Czechs) to data published by the ROME IV foundation with various cohorts of patients with FD and its results further demonstrate the long-term benefits and safety profile of itopride with minimal non-AEs.

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