Real World Efficacy and Tolerability of Acotiamide in Relieving Multiple and Overlapping Symptoms in Patients of Functional Dyspepsia

Background: Functional Dyspepsia (FD) is a common clinical conditionthat can significantly affectquality of life. Patients present withmeal-related FD symptoms like post-prandial fullness, and early satiety (PDS type) and/or epigastric pain/discomfort (EPS type), however common presentation is with a mix of both EPS and PDS symptoms which can also coexist with abdominal bloating, heartburn and belching. This often poses a therapeutic challenge for the clinicians as poorly-defined and overlapping symptoms can hamper effective treatment selection. Acotiamide is a first-in-class drug that exerts its gastro-kinetic effect by enhancing acetylcholine release. Evidence from randomized clinical studies as well as real world in clinic data capture is available for its efficacy and tolerance in relieving meal related PDS type symptoms however data on effects of Acotiamide on other commonly coexisting symptoms like abdominal pain/discomfort, bloating, belching and heartburn as seen commonly inreal world,is currently lacking.

Methodology: In this study, 1525 FD patients visiting 148 gastroenterology clinics across India, received Acotiamide 100 mg thrice daily. These patients were assessed by the treating physician for patient’s perception of improvement in the presenting symptoms, as well as tolerance to treatment.

Results: Complete relief or significant improvement from Upper abdominal (epigastric) pain, Upper abdominal (epigastric) discomfort, Upper abdominal bloating, Excessive belching and Heartburn was seen in 65.5%, 75.5%, 77.4%, 68.7% and 64% patients respectively. (P<0.001 for all mentioned values versus no/slight improvement). Almost 50% of the patients obtained symptomatic relief with Acotiamide as early as 1-2 weeks of therapy. Overall, symptomatic improvement with Acotiamide did not differ between groups with and without a PPI as co-therapy. Adverse events were reported by 1.3% patients and were mild and transient in nature without need for cessation of Acotiamide.

Conclusion: This real-world study suggests that use of Acotiamidecan also improve overlapping symptoms of upper abdominal pain, bloating and discomfort, belching and heartburn which often coexist with meal related PDS type symptoms in FD patients.

Keywords: Rome Criteria, Functional Dyspepsia, Acotiamide, Overlapping, Upper Abdominal Pain, discomfort, Bloating, Belching, Heartburn.