Efficacy of Acotiamide in PDS type Functional Dyspepsia symptoms with and without PPI and laxative co-therapy

Abstract

Background: Functional Dyspepsia (FD) is a common condition presenting at the clinic of a gastroenterologist. Though the Post-prandial Distress Syndrome (PDS) type is more commonly seen in clinical practice, often the symptoms overlap with Epigastric pain or burning and sometimes even with other gastro-intestinal symptoms like constipation. Acotiamide, approved specially for meal related FD symptoms, exerts its gastro- kinetic effect by enhancing the action of acetylcholine. Evidence of its efficacy and safety are available from various randomized clinical trials. However, real-world data from its regular in-clinic use especially in patients presenting with overlapping symptoms and being prescribed other concomitant therapies, is lacking. Methodology: Data, evaluated from 314 patients through questionnaires to record patient’s perception of improvement in the presenting symptoms, as well as tolerance to treatment with acotiamide 100 mg thrice daily, across gastroenterology clinics in India, was analyzed. Results: The responder rate for treatment with acotiamide in the groups receiving only acotiamide and in those also receiving Proton Pump Inhibitor (PPI) and laxatives as concomitant therapy, for each of functional dyspepsia symptoms of post prandial fullness, upper abdominal bloating and early satiety was 72.5% and 86.5%, 68.8% and 80.2%, and, 80% and 74.1% respectively. No significant difference was seen in the number of patients achieving complete relief or significant improvement from both post prandial fullness and early satiety at final follow up between the two groups. A significant difference was seen in the number of patients who ‘significantly improved’ from epigastric bloating in the group co-prescribed a PPI or a laxative with acotiamide versus the group which was only given acotiamide. Overall a low treatment discontinuation rate of 1.3% was observed. Conclusion: This real-world study suggests that use of acotiamide is associated with improvement of mealrelated (PDS) FD symptoms with good safety profile, in patients also receiving a PPI or a laxative for other overlapping symptoms with PDS.