PGI3 - Real World, Non-Interventional, Observational Study to Evaluate Effectiveness and Tolerability of Acotiamide Hydrochloride Hydrate in Indian Patients with Functional Dyspepsia

Abstract

To assess effectiveness & tolerability of Acotiamide hydrochloride hydrate in management of Indian patients with functional dyspepsia over 4 weeks period This was prospective, observational, real world study involving 132 patients (85 male, 47 female), aged >18 years, having functional dyspepsia as per Rome III criteria and treated with Acotiamide 100mg three times daily for 4 weeks at a tertiary care centre in India. Primary outcome was responders based on Overall Treatment Efficacy (OTE) recorded on a 7-point Likert scale for post-prandial distress syndrome (post-prandial fullness, early satiety and upper abdominal bloating), epigastric pain syndrome (Upper abdominal pain & discomfort) and associated symptoms of dyspepsia (nausea, vomiting and excessive belching) at the end of 2 and 4 weeks. Secondary outcomes were elimination of symptoms (post-prandial fullness, early satiety and upper abdominal bloating), quality of life assessed on Short-Form Nepean Dyspepsia Index (SFNDI) questionnaire and tolerability over 4 weeks of treatment The responder rates with Acotiamide at 2 and 4 weeks were 51.5% and 65.9% for post-prandial distress syndrome, 31.8%, and 41.7% for epigastric pain syndrome and 16.7% and 17.4% for associated dyspeptic symptoms respectively. Symptom elimination rates were 9.8% and 18.9% for post-prandial fullness, 12.9% and 22.0% for early satiety, and 18.9% and 24.2% for upper abdominal bloating at 2 and 4 weeks respectively. Significant improvement in quality of life as measured on SFNDI total scores, was reported from 25.91 (5.00) at 2 weeks to 23.76 (4.84) at 4 weeks(p<0.0001). Total 7 (5.30%) patients reported mild intensity adverse events which were dizziness (4 patients), headache (3 patients) and nausea (1 patient). Acotiamide demonstrates effectiveness through improvement in symptoms of post-prandial distress syndrome, epigastric pain syndrome and associated dyspepsia symptoms, along with significant improvement in quality of life over a 4-wk treatment period and is well tolerated in Indian patients with functional dyspepsia.