Real-World, Non-Interventional, Observational Study to Evaluate Effectiveness and Tolerability of Acotiamide Hydrochloride Hydrate in Treatment of Functional Dyspepsia.

Abstract

Functional dyspepsia (FD) is a highly prevalent condition which reduces patients' quality of life (QoL) and imparts a significant economic burden on the healthcare system. Acotiamide is a novel prokinetic agent useful in treatment of FD, and this study evaluated the effectiveness of acotiamide hydrochloride hydrate in management of FD over a 4-week period in a real-world setting. This study was a prospective, observational, real-world data collection of 132 patients (85 male, 47 female) over 18years of age diagnosed with FD as per Rome III criteria and treated with acotiamide for 4weeks at a gastroenterology unit of a medical school in India. Those receiving prokinetics and cholinergic drugs, having any structural lesion on endoscopy, with coexisting irritable bowel syndrome and having heartburn in the past 12weeks were excluded. Primary outcome was responders based on overall treatment efficacy (OTE) recorded on a seven-point Likert scale for postprandial distress syndrome (PDS; postprandial fullness, early satiety and upper abdominal bloating), epigastric pain syndrome (EPS; upper abdominal pain and upper abdominal discomfort) and associated symptoms (nausea, vomiting and excessive belching) at the end of 2 and 4weeks. Secondary outcomes were elimination of symptoms of PDS, QoL assessed on the Short-Form Nepean Dyspepsia Index (SFNDI) questionnaire and clinical safety after 2 and 4weeks. The responder rates with acotiamide at 2 and 4weeks were 51.5% and 65.9%, respectively, for PDS. Similarly, the responder rates for EPS were 31.8% and 41.7%, respectively, at 2weeks and 4weeks. The responder rates for associated symptoms of nausea, vomiting and excessive belching were respectively 18.2%, 17.4% and 16.7% at 2weeks and 18.2%, 17.4% and 18.2% at 4weeks. Symptom elimination rates were 9.8% and 18.9% for postprandial fullness, 12.9% and 22.0% for early satiety, and 18.9% and 24.2% for abdominal bloating at 2 and 4weeks, respectively. Significant improvement (p < 0.0001) in the SFNDI total scores from 25.91 (5.00) at 2weeks to 23.76 (4.84) at 4weeks were found at 4weeks compared to 2weeks. A total of 7 (5.30%) patients reported mild adverse events which were dizziness (4), headache (3) and nausea (1). The current study demonstrates that treatment with acotiamide improves symptoms, QoL and is well tolerated in Indian patients with FD. Clinical Trial Registry of India, CTRI/2017/11/010421. Dr. Reddy's Laboratories, India.