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Efficacy of Acotiamide in PDS Type Functional Dyspepsia Symptoms with and without PPI and Laxative Co-Therapy
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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.
Keywords
- Suzuki H. The Application of the Rome IV Criteria to Functional Esophagogastroduodenal Disorders in Asia. J Neurogastroenterol Motil. 2017 Jul; 23(3): 325–333
- Mahadeva S, Goh KL. Epidemiology of functional dyspepsia: A global perspective. World J Gastroenterol 2006 May 7; 12(17): 2661-2666
- Talley et al. AGA Technical Review: Evaluation of Dyspepsia. Gastroenterology. 1998;114:582
- Ghoshal UC, Singh R. Frequency and risk factors of functional gastro-intestinal disorders in a rural Indian population. J Gastroenterol Hepatol. 2017 Feb;32(2):378-387
- Waseem S et al. Gastroparesis: Current diagnostic challenges and management considerations. World J Gastroenterol. 2009 Jan 7; 15(1): 25–37
- Tack J, Janssen P. Acotiamide (Z-338, YM443), a new drug for the treatment of functional dyspepsia. Expert Opin. Investig. Drugs (2011) 20(5):701-712
- Tack J et al. Long-term safety and efficacy of Acotiamide in functional dyspepsia (postprandial distress syndrome)results from the European phase 3 open-label safety trial. NeurogastroenterolMotil. 2018 Jan 8. doi: 10.1111/nmo.13284. [Epub ahead of print]
- Matsueda K, Hongo M, Ushijima S, Akiho H. A Long-Term Study of Acotiamide in Patients with Functional Dyspepsia: Results from an Open-Label Phase III Trial in Japan on Efficacy, Safety and Pattern of Administration. Digestion. 2011; 84. 261-8.
- B. E. Lacy, K. T. Weiser, A. T. Kennedy, M. D. Crowell & N. J. Talley. Functional dyspepsia: the economic impact to patients Aliment Pharmacol Ther 2013; 38: 170–177
- P. Aro, N. J. Talley, L. Agreus, S. E. Johansson, E. BollingSternevald, T. Storskrubb& J. Ronkainen. Functional dyspepsia impairs quality of life in the adult Population Aliment Pharmacol Ther 2011; 33: 1215–1224
- Narayanan V et al. Real World Efficacy and Tolerability of Acotiamide, in Relieving Meal- related Symptoms of Functional Dyspepsia. J Gastrointest Dig Syst 2018, 8:1
- Matsueda K, Hongo M, Tack J, Saito Y, Kato H.A placebocontrolled trial of Acotiamide for meal-related symptoms of functional dyspepsia. Gut 2012. 61. 821-8. 10.1136/ gutjnl-2011-301454
- Kusunoki H, Haruma K, Manabe N. Therapeutic efficacy of Acotiamide in patients with functional dyspepsia based on enhanced postprandial gastric accommodation and emptying: randomized controlled study evaluation by real-time ultrasonography. Neurogastroenterol. Motil. 2012; 24(6):540-5, e250
- Nakamura K et al. A double-blind placebo-controlled study of Acotiamide hydrochloride for efficacy on gastrointestinal motility of patients with functional dyspepsia. J Gastroenterol. 2017 May;52(5):602-610
- Mayanagi S et al. Efficacy of Acotiamide in Combination with Esomeprazole for Functional Dyspepsia Refractory to Proton-Pump Inhibitor Monotherapy. Tohoku J. Exp. Med., 2014, 234, 237-240
- Takeuchi T et al. Therapy of gastroesophageal reflux disease and functional dyspepsia overlaps with symptoms after usual-dose proton pump inhibitor: Acotiamide plus usualdose proton pump inhibitor versus double-dose proton pump inhibitor. Journal of Gastroenterology and Hepatology 33 (2018) 623–630.
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