Dhruva Bhat, Mukunda N, Lokesh L V
Dhruva Bhat1, Mukunda N1*, Lokesh L V2
1Department of Pharmacology, M S Ramaiah Medical College, Bengaluru – 560054, Karnataka, India.
2Department of Gastroenterology, M S Ramaiah Medical College, Bengaluru – 560054, Karnataka, India.
Volume - 15,
Issue - 6,
Year - 2022
Aim: The aim of this study was to assess the effect of acotiamide and esomeprazole combination therapy in improving Functional Dyspepsia (FD) - related symptoms in comparison with acotiamide or esomeprazole monotherapy. Materials and Methods: This was a prospective observational study conducted in patients attending outpatient department of Gastroenterology, M S Ramaiah Hospitals and diagnosed to have functional dyspepsia based on Rome IV criteria. Group 1 received acotiamide, group 2 received esomeprazole and group 3 received acotiamide plus esomeprazole combination therapy for a period of 6 weeks. The efficacy of treatment was assessed using symptom assessment scale. We also assessed the responder rate, resolution rate and treatment emergent adverse events. Results: In this study a total of 52 patients completed the study in each group. There was a statistically significant improvement in symptom assessment scale - Epigastric pain syndrome (EPS), Postprandial distress syndrome (PDS), Total Abdominal Symptom (TAS) scores from baseline to 6 weeks in all the 3 treatment groups (p <0.001). Combination therapy (group 3) showed maximum reduction from baseline to week 6 (mean differences of 11.07, 3.53 and 5.65 in TAS, EPS, PDS scores respectively). The common adverse events reported were fever, headache, diarrhoea and nasopharyngitis. Conclusion: Combination therapy of acotiamide with esomeprazole was effective in reducing symptom scores at the end of 6 weeks in patients with FD as compared to monotherapy with either of the drugs.
Cite this article:
Dhruva Bhat, Mukunda N, Lokesh L V. Effect of Acotiamide and Esomeprazole combination therapy on Functional Dyspepsia symptoms in comparison with Acotiamide or Esomeprazole Monotherapy: A Prospective Observational Study. Research Journal of Pharmacy and Technology. 2022; 15(6):2571-6. doi: 10.52711/0974-360X.2022.00430
Dhruva Bhat, Mukunda N, Lokesh L V. Effect of Acotiamide and Esomeprazole combination therapy on Functional Dyspepsia symptoms in comparison with Acotiamide or Esomeprazole Monotherapy: A Prospective Observational Study. Research Journal of Pharmacy and Technology. 2022; 15(6):2571-6. doi: 10.52711/0974-360X.2022.00430 Available on: https://rjptonline.org/AbstractView.aspx?PID=2022-15-6-34
1. Xiao G. Xie X. Fan J. Deng J. Tan S. Zhu Y et al. Efficacy and Safety of Acotiamide for the Treatment of Functional Dyspepsia: Systemic Review and Meta-Analysis. The Scientific World Journal. 2014; 2014:1-9.
2. Shinozaki S. Osawa H. Sakamoto H. Hayashi Y. Lefor AK. Yamamoto H. The effect of acotiamide on epigastric pain syndrome and post prandial distress syndrome in patients with functional dyspepsia. The Journal of Medical Investigation. 2016; 63(3): 230-35.
3. Matole V. Birajdar A. Ingle S. Adlinge S. Nangare G. Madur S et al. UV Spectrophotometric Method Development and Validation of Acotiamide in Bulk and Solid Dosage Form. Asian J. Pharm. Ana. 2020; 10(3): 147-149. doi: 10.5958/2231-5675.2020.00026.5.
4. Sahare K. Hemke A. Dhawale S. Umekar M. Development of UV-Spectrophotometric methods and Determination of dissolution profile of Acotiamide Hydrochloride Hydrate. Research J. Pharm. and Tech. 2021; 14(2):628-632. doi: 10.5958/0974-360X.2021.00112.8
5. Ghosh S. Karati D. Roy T. Ravikumar BV. Spectrophotometric method Development and validation of Acotiamide in its bulk and Tablet Dosages Form. Research J. Pharm. and Tech. 2020; 13(3): 1463-1466. doi: 10.5958/0974-360X.2020.00267.X
6. Gosavi SA. Bhavar GB. Chepurwar SB. Shirkhedkar AA. Bari SB. Surana SJ. Estimation of Esomeprazole in Bulk and Tablet Dosage Form by Use of Planar Chromatography. Research J. Pharm. and Tech. 2010; 3(4):1185-1188.
7. Barse SA. Gosavi SA. Kasture VS. Comparative Spectrophotometric Analysis of Simultaneous Estimation of Esomeprazole and Domperidone in Tablet Dosage Form. Research J. Pharm. and Tech. 2011; 4(9): 1363-1366.
8. Van Zanten S. Armstrong D. Chiba N. Flook N. White R. Chakraborty B et al. Esomeprazole 40 mg Once a Day in Patients with Functional Dyspepsia: The Randomized, Placebo-Controlled “ENTER” Trial. The American Journal of Gastroenterology. 2006;101(9): 2096-06.
9. Stanghellini V. Chan FKL. Hasler WL. Malagelada JR. Suzuki H. Tack J et al. Gastroduodenal disorders. Gastroenterology. 2016;150(6): 1380–92.
10. Mayanagi S. Kishino M. Kitagawa Y. Sunamura M. Efficacy of Acotiamide in Combination with Esomeprazole for Functional Dyspepsia Refractory to Proton-Pump Inhibitor Monotherapy. The Tohoku Journal of Experimental Medicine. 2014; 234(3): 237-40.
11. Suzuki H. The Application of Rome IV Criteria to Functional Esophagogastroduodenal Disorders in Asia. Journal of Neurogastroenterology and Motility. 2017; 23(3): 325-33.
12. Hojo M. Nagahara A. Asaoka D. Takeda T. Izumi K. Matsumoto K et al. A Randomized, Double-Blind, Pilot Study of the Effect of Famotidine on Acotiamide Treatment for Functional Dyspepsia. Digestion. 2017; 96(1): 5-12.
13. Matsueda K. Hongo M. Tack J. Saito Y. Kato H. A placebo-controlled trial of acotiamide for meal-related symptoms of functional dyspepsia. Gut. 2011; 61(6): 821-28.
14. Burke LB. Kennedy DL. Miskala PH. The use of patient-reported outcome measures in the evaluation of medical products for regulatory approval. Clin Pharmacol Ther. 2008; 84: 281-83.
15. 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: 261–68.