Comparative Analysis of the Treatment Outcomes of Itopride and Acotiamide in Functional Dyspepsia: A Real-World Retrospective Study

Background: Functional dyspepsia (FD) is a prevalent gastric neuromuscular disorder affecting approximately 20% of the global population, with significant economic implications, particularly in India, where prevalence rates vary between 7.6% and 49%. Characterized by epigastric pain, early satiety, and postprandial fullness, FD lacks identifiable anatomical abnormalities, complicating treatment. Prokinetic agents like Itopride and Acotiamide are commonly used, but face variability in treatment. Objective: This study aimed to evaluate the effectiveness and safety of Itopride versus Acotiamide in managing FD symptoms in a real-world Indian context. Methods: This retrospective study analysed prospectively maintained data (from January to August 2024) across three sites in India. Seventy-nine patients (57 on Itopride and 22 on Acotiamide) were assessed for symptom improvement at 4 and 8-weeks post-treatment initiation, using the Patient Assessment of Upper Gastrointestinal Symptom Severity Index (PAGI-SYM). Symptom severity grades were compared between treatment groups using the Fischer exact or Chi-square test. Results: The mean age of FD patients was 45.59 years, with 46.8% male and demographic parameters were similar across both treatment groups. Itopride treatment significantly reduced symptom severity for epigastric pain, burning, early satiation, and postprandial fullness (p≤0.05) compared to the baseline, while Acotiamide showed non-significant improvements at both 4 and 8 weeks. Between treatment, comparison found fewer high symptom severity grades with Itopride than Acotiamide treatment (e.g. 1.75% vs. 13.64%, p=0.003, for epigastric pain, 8 weeks treatment). Also, after 8 weeks, 61.4% of Itopride patients reported symptom resolution, contrasted with 31.82% in the Acotiamide group. Adverse events were mild and infrequent in both groups, indicating comparable safety profiles. Conclusion: This study provides valuable real-world evidence supporting the use of Itopride as a preferred treatment option for FD in India. Further research is warranted to establish long-term efficacy and safety across diverse populations. Keywords: Functional Dyspepsia; Itopride; Acotiamide; Prokinetic Agents; Symptom Severity Grades