Clinical efficacy of acotiamide in patients with functional dyspepsia: results of a multicenter study

Introduction. Despite the high prevalence of functional dyspepsia (FD), the question of effective treatment of this pathology remains open. This underlines the relevance of new approaches in the treatment of FD and the introduction of the drug Dyspevict® (acotiamide), a prokinetic with a new mechanism of action, into clinical practice to alleviate symptoms and improve the quality of life of patients with FD.

Aim. Evaluate the efficacy and safety of the use of acotiamide in patients with FD with postprandial distress syndrome (PDS).

Materials and methods. 389 patients were randomized in a 1:1 ratio into two groups. Patients of the first group took acotiamide, patients of the second group – placebo. Study drugs were taken orally for 4 weeks. The main criterion for the effectiveness of treatment was the “response to therapy”, assessed by patients on a 7-point Likert scale. Secondary efficacy criteria were: complete regression or relief of symptoms of FD with PDS, improvement in the quality of life of patients, which was assessed on the basis of the Nepean short dyspepsia index.

Results and discussion. After 4 weeks, “response to therapy” was observed in 143/193 (74.1%) patients in the acotiamide group compared with 98/189 (51.9%) patients in the placebo group (p < 0.001). Therapy with Acotiamide, in contrast to placebo, showed a complete regression and relief of some symptoms of FD with PDS. Also, after the use of acotiamide, there was an improvement in well-being and quality of life in 172/194 (88.7%) patients compared with 131/189 (69.3%) patients in the placebo group (p < 0.001).

Conclusion. The results of the conducted clinical study allow us to conclude that acotiamide is an effective treatment for FD with PDS in adults. The safety profile of the drug is comparable to placebo.

1. Sperber A.D., Bangdiwala S.I., Drossman D.A., Ghoshal U.C., Simren M., Tack J. et al. Worldwide Prevalence and Burden of Functional Gastrointestinal Disorders, Results of Rome Foundation Global Study. Gastroenterology. 2021;160(1):99–114.e3. https://doi.org/10.1053/j.gastro.2020.04.014.

2. Lyalyukova E.A., Batishcheva G.A., Vise- Khripunova M.A., Lapina E.D., Lyalyukova A.S., Onuchina E.V. et al. Dyspepsia Syndrome in Primary Health Care: Clinical Options, Patient Management Tactics. Trudnyj Pacient. 2019;(6–7):38–46. (In Russ.) Available at: https://t-pacient.ru/wp-content/uploads/2019/10/9-new.pdf.

3. Simanenkov V.I., Maev I.V., Tkacheva O.N., Alekseenko S.A., Andreev D., Bakulina N.V. et al. Epithelial protective therapy in comorbid diseases. Practical Guidelines for Physicians. Terapevticheskii Arkhiv. 2022;94(8):940–956. (In Russ.) https://doi.org/10.26442/00403660.2022.08.201523.

4. Ford A.C., Mahadeva S., Carbone M.F., Lacy B.E., Talley N.J. Functional dyspepsia. Lancet. 2020;396(10263):1689–1702. https://doi.org/10.1016/S0140-6736(20)30469-4.

5. Aziz I., Palsson O.S., Törnblom H., Sperber A.D., Whitehead W.E., Simrén M. Epidemiology, clinical characteristics, and associations for symptom- based Rome IV functional dyspepsia in adults in the USA, Canada, and the UK: a cross- sectional population-based study. Lancet Gastroenterol Hepatol. 2018;3(4):252–262. https://doi.org/10.1016/S2468-1253(18)30003-7.

6. Lazebnik L.B., Alekseenko S.A., Lyalyukova E.A., Samsonov A.A., Bordin D.S., Tsukanov V.V. et al. Recommendations for the management of primary patients with symptoms of dyspepsia. Experimental and Clinical Gastroenterology. 2018;(5):4–18. (In Russ.) Available at: https://www.nogr.org/jour/article/view/605/600.

7. Sheptulin A.A., Belousova I.B. Modern prokinetics and their role in the treatment of gastroenterological diseases. Clinical Medicine (Russian Journal). 2016;94(3):178–182. (In Russ.) https://doi.org/10.18821/00232149-2016-94-3-178-182.

8. Stanghellini V., Chan F.K., Hasler W.L., Malagelada J.R., Suzuki H., Tack J., Talley N.J. Gastroduodenal Disorders. Gastroenterology. 2016;150(6):1380–1392. https://doi.org/10.1053/j.gastro.2016.02.011.

9. Miwa H., Kusano M., Arisawa T., Oshima T., Kato M., Joh T. et al. Evidence- based clinical practice guidelines for functional dyspepsia. J Gastroenterol. 2015;50(2):125–139. https://doi.org/10.1007/s00535-014-1022-3.