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Real World Efficacy and Tolerability of Acotiamide, in Relieving Mealrelated Symptoms of Functional Dyspepsia | OMICS International| Abstract
ISSN: 2161-069X

Journal of Gastrointestinal & Digestive System
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  • Research Article   
  • J Gastrointest Dig Syst 2018, Vol 8(1): 553
  • DOI: 10.4172/2161-069X.1000553

Real World Efficacy and Tolerability of Acotiamide, in Relieving Mealrelated Symptoms of Functional Dyspepsia

Varsha Narayanan*, Amit Bhargava and Shailesh Pallewar
Department of Medical Services and Research, Lupin Ltd., , India
*Corresponding Author : Varsha Narayanan, Department of Medical Services and Research, Lupin Ltd., Mumbai, India, Tel: +912266402222, Email: [email protected]

Received Date: Feb 09, 2018 / Accepted Date: Feb 21, 2018 / Published Date: Feb 27, 2018

Abstract

Background: Functional Dyspepsia (FD) is a highly prevalent clinical condition that imposes negative economic burden on health-care system as well as greatly impairs quality of life. Treatment of non-specific and bothersome meal-related FD symptoms like post-prandial fullness, upper abdominal bloating and early satiety, is a therapeutic challenge for the clinicians as poorly-defined and ill-understood pathogenesis has hampered efforts to develop effective treatments. Acotiamide is first-in-class drug that exerts its gastro-kinetic effect by enhancing acetylcholine release. Though evidence of its efficacy and tolerance are available through randomized clinical trials, real world data from its regular in-clinic use is lacking.
Methodology: In this study, 314 FD patients with meal-related-symptoms, visiting 63 gastroenterology clinics across India, received Acotiamide 100 mg thrice daily for 4 weeks. These patients were retrospectively evaluated with a questionnaire to record patient’s perception on improvement in the presenting symptoms, as well as tolerance to treatment.
Results: It was observed that, complete relief or significant improvement from post prandial fullness, upper abdominal bloating and early satiety was achieved by 79.2%, 74.4%, and 77.1% patients respectively. (P<0.001 for all vs. no/slight improvement). Significantly more number of patients achieved complete relief when treated for >28 days or 14-28 days than when treated for less than 2 weeks (P<0.05). Adverse events were reported by 6% patients; mainly headache, nausea, vomiting, vertigo, burning sensation, palpitation, and epigastric pain, and were all mild and transient in nature.
Conclusion: This real world study suggests that use of Acotiamide was associated with improvement of mealrelated FD symptoms with good safety profile.

Keywords: Rome III criteria; Functional dyspepsia; Acotiamide; Prokinetic; Post prandial fullness; Abdominal bloating; Early satiety; Impaired gut motility

Citation: Narayanan V, Bhargava A, Pallewar S (2018) Real World Efficacy and Tolerability of Acotiamide, in Relieving Meal-related Symptoms of Functional Dyspepsia. J Gastrointest Dig Syst 8: 553. Doi: 10.4172/2161-069X.1000553

Copyright: © 2018 Narayanan V, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

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