Priorities in choosing prokinetic for patients with functional dyspepsia: Focus on itopride
https://doi.org/10.33667/2078-5631-2022-28-28-32
Abstract
Functional dyspepsia is a widespread disease with many symptoms that reduce the patient's quality of life. The effectiveness of prokinetics, including in combination with proton pump inhibitors, has a high level of scientific evidence in the treatment of functional dyspepsia. The effectiveness of itopride hydrochloride is determined by a dual mechanism of action: antagonism to D 2-dopamine receptors and inhibition of acetylcholinesterase. The drug exceeds of metoclopramide and domperidone in safety in relation to cardiac and neurological disorders. Itopride hydrochloride is not expected to have pharmacokinetic interactions with other drugs metabolized by the CYP3A4 system. In addition to functional dyspepsia, itopride hydrochloride is indicated in the treatment of chronic gastritis, gastrointestinal symptoms associated with gastric dysmotility or delayed gastric emptying, such as bloating, rapid satiety, a feeling of fullness in the stomach after eating, pain or discomfort in the epigastric region, loss of appetite, heartburn, nausea and vomiting. The pharmacoeconomic analysis shows an advantage of Itopride-SZ in comparing of the direct cost of it with the original and several generic drugs. In this way, it allows recommend Itopride-SZ as an affordable drug for various cohorts of patients.
About the Authors
A. E. Babich
Kuban State Medical University; Euromed’ Clinic
Russian Federation
Russian Federation
Babich Anna E., assistant at Dept of Public Health, Health Care and History of Medicine; gastroenterologist
Krasnodar
N. A. Zubareva
Kuban State Medical University; Research Institute – Regional Clinical Hospital No. 1 n.a. professor S.V. Ochapovsky
Russian Federation
Russian Federation
Zubareva Natalya A., assistant at Dept of Therapy No. 1; chief freelance clinical pharmacologist of the Ministry of Health of the Krasnodar Territory, clinical pharmacologist
Krasnodar
G. G. Ketova
South Ural State Medical University
Russian Federation
Russian Federation
Ketova Galina G., Dm Sci (habil.), professor, professor at Dept of Polyclinic Therapy and Clinical Pharmacology
Chelyabinsk
References
1. Drossman D.A. Functional Gastrointestinal Disorders: History, Pathophysiology, Clinical Features and Rome IV. Gastroenterology 2016; 150: 1262-79.
2. Лазебник Л.Б., Голованова Е.В., Волель Б.А. и др. Функциональные заболевания органов пищеварения. Синдромы перекреста. Клинические рекомендации Российского научного медицинского общества терапевтов и Научного общества гастроэнтерологов России. Экспериментальная и клиническая гастроэнтерология. 2021; 192 (8): 5-117. DOI: 10.31146/1682-8658-ecg-192-8-5-117. Lazebnik L.B., Golovanova E.V., Volel B.A. et al. Functional diseases of the digestive system. Cross syndromes. Clinical recommendations of the Russian Scientific Medical Society of Therapists and the Scientific Society of Gastroenterologists of Russia. Experimental and Clinical Gastroenterology. 2021; 192 (8): 5-117. DOI: 10.31146/1682-8658-ecg-192-8-5-117.
3. Stanghellini V., Chan F.K.L.., Hasler WL. et al. Gastro duodenal disorders. Gastroenterology. 2016; 150: 1380-92.
4. Paul M; Lacy, Brian E; Andrews, Christopher N; Enns, Robert A; Howden, Colin W; Vakil, Nimish. ACG and CAG Clinical Guideline: Management of Dyspepsia. Moayyedi, American Journal of Gastroenterology: July 2017; Volume 112, Issue 7, pp. 988-1013. DOI: 10.1038/ajg.2017.154.
5. Wauters L., Dickman R., Drug V., Mulak A., Serra J., Enck P. et al. United European Gastroenterology (UEG) and European Society for Neurogastroenterology and Motility (ESNM) consensus on functional dyspepsia. United European Gastroenterol J. 2021; 9 (3): 307-331. https://doi.org/10.1002/ueg2.12061
6. Шептулин А. А., Сторонова О. А., Румянцева Д. Е. Согласительное совещание Европейского общества нейрогастроэнтерологии и моторики по функциональной диспепсии (2020): все ли точки над i уже расставлены? Российский журнал гастроэнтерологии, гепатологии, колопроктологии. 2021; 31 (2): 40-45. https://doi.org/10.22416/1382-4376-2021-31-2-40-45 Sheptulin A.A., Storonova O.A., Rumyantseva D.E. Conciliation meeting of the European Society of Neurogastroenterology and Motility on Functional Dyspepsia (2020): Are all i dotted already? Russian Journal of Gastroenterology, Hepatology, Coloproctology. 2021; 31 (2): 40-45. https://doi.org/10.22416/1382-4376-2021-31-2-40-45
7. Государственный реестр лекарственных средств: grls.rosminzdrav. ru. State Register of Medicines: grls.rosminzdrav. ru.
8. Ивашкин В.Т., Маев И.В., Шептулин А.А., Лапина Т.Л., Трухманов А.С., Картавенко И.М. и др. Клинические рекомендации Российской гастроэнтерологической ассоциации по диагностике и лечению функциональной диспепсии. Российский журнал гастроэнтерологии, гепатологии, колопроктологии. 2017; 27(1): 50-61. Режим доступа: https://www.gastro-j.ru/jour/article/view/123. Ivashkin V.T., Mayev I.V., Sheptulin A.A., Lapina T.L., Trukhmanov A.S., Kartavenko I.M. et al. Diagnosis and treatment of the functional dyspepsia: clinical guidelines of the Russian Gastroenterological Association. Russian Journal of Gastroenterology, Hepatology, Coloproctology. 2017; 27 (1): 50-61. (In Russ.) Available at: https://www.gastro-j.ru/jour/article/view/123.
9. Маев И.В., Дичева Д.Т., Щегланова М.П., Андреев Д.Н., Заборовский А.В. Функциональная диспепсия в свете Римских критериев IV пересмотра (2016). Consilium Medicum. Гастроэнтерология. 2016. № 2. 6 с. Maev I.V., Dicheva D.T., Shcheglanova M.P., Andreev D.N., Zaborovsky A.V. Functional dyspepsia in the light of the Rome IV criteria revision (2016). Consilium Medicum. Gastroenterology. 2016. No. 2. 6 p.
10. Лазебник Л.Б., Алексеенко С.А., Лялюкова Е.А., Самсонов А.А., Бордин Д.С., Цуканов В.В. и др. Рекомендации по ведению первичных пациентов с симптомами диспепсии. Экспериментальная и клиническая гастроэнтерология. 2018; (5): 4-18. Режим доступа: https://www.nogr.org/jour/article/view/605/600. Lazebnik L.B., Alekseenko S.A., Lyalyukova E.A., Samsonov A.A., Bordin D.S., Tsukanov V.V. et al. Guidelines on primary patient management in dyspepsia. Experimental and Clinical Gastroenterology. 2018; (5): 4-18. (In Russ.) Available at: https://www.nogr.org/jour/article/view/605/600
11. Сюняева Л.А., Шульпекова Н.В., Лапина Т.Л. Диспепсия: терминология, причины и факторы риска, тактика ведения пациентов. Медицинский совет. 2022; 16 (7): 44-51. https://doi.org/10.21518/2079-701X-2022-16-7-44-51 Sunyaeva L.A., Shulpekova N.V., Lapina T.L. Dyspepsia: terminology, causes and risk factors, patient management tactics. Medical Advice. 2022; 16 (7): 44-51. https://doi.org/10.21518/2079-701X-2022-16-7-44-51
12. Miwa H., Nagahara A., Asakawa A., Arai M., Oshima T., Kasugai K. et al. Evidence-based clinical practice guidelines for functional dyspepsia 2021. J Gastroenterol. 2022; 57 (2): 47-61. https://doi.org/10.1007/s00535-021-01843-7.
13. Holtmann G., Talley N.J., Liebregts T., Adam B., Parow C. A placebo-controlled trial of itopride in functional dyspepsia. N. Engl. J. Med. 2006 Feb 23; 354 (8): 832-40. DOI: 10.1056/nejmoa052639.
14. Sun J., Yuan Y.Z., Holtmann G. Itopride in the treatment of functional dyspepsia in Chinese patients: a prospective, multicentre, post-marketing observational study. Clin. Drug. Investig. 2011 Dec 1; 31 (12): 865-75.
15. Inoue K., Sanada Y., Fijimura J., Mihara O. Clinical Effect of Itopride Hydrochloride on the Digestive Symptoms of Chronic Gastritis with Reflux Esophagitis. Clinical. Medicine. 1999; 15 (11): 105-11.
16. Ravindra M., Kakrani A.L. Clinical evaluation of itopride hydrochloride in patients with nonulcer dyspepsia and chronic gastritis. The Indian Practitioner. 2002; 55: 1-6.
17. Kamath S., Vinod K., Verghese J., Bhatia S. Comparative Evaluation of the Efficacy and Tolerability of Itopride and Metoclopramide in Patients with Non-Ulcer Dyspepsia. JAMA-India. 2003; 2 (8): 95-8.
18. Sawant P., Das H.S., Desai H., Kalokhe S., Patil S. Comparative evaluation of the efficacy and tolerability of itopride hydrochloride and domperidone in patients with non-ulcer dyspepsia. J. Assoc. Physicians India. 2004; 52: 626-8.
19. Walwaikar P.P., Kulkarni S.S., Bargaje R.S. Evaluation of new gastrointestinal prokinetic (ENGIP_II) study. J. Indian Med. Assoc. 2005; 103 (12): 708-9.
20. Huang X., Lu B., Zhang S. et al. Itopride therapy for functional dyspepsia: a meta-analysis. World J Gastroenterol 2012; 18 (48): 7371-7.
21. Tack J. Prokinetics and fundic relaxants in upper functional GI disorders. Gurr. Opin. Pharmacol. 2008; 8 (6): 690-6.
22. Chun B.J., Lee D.S. The effect of itopride combined with lansoprazole in patients with laryngopharyngeal reflux disease. Eur. Arch. Otorhinolaryngol. 2013 Mar; 270 (4): 1385-90.
23. Mushiroda T., Douya R., Takahara E. et al. The involment of flavin containg monooxyge_nase bun not CYP3A4 in metabolism of itopride hydrochloride, a gastroprokinetic agent: comparaison with cisapride and mosapri_de citrate. Drug. Metabol. Dispos. 2000; 28: 1231-37.
24. Tack J. New therapeutic targets for FD: What, how and whom? In: Functional dyspepsia: current evidence and cutting-edge outcomes. Abstract book. Montreal, 2005, pp. 22-24.
25. Sahoo B.K., Das A., Agarwal S. et al. Pharmacokinetics and bioequivalence study of a fixed dose combination of rabeprazole and itopride in healthy Indian volunteers. Arzneimittelforschung. 2009; 59 (9): 451-4.
26. Владимирова Л. Ю., Гладков О. А., Королева И. А., Румянцев А. А., Семиглазова Т. Ю., Трякин А. А., Кутукова С. И., Овчинникова Е. Г., Новикова О. Ю., Корниецкая А.Л. Практические рекомендации по профилактике и лечению тошноты и рвоты у онкологических больных. Злокачественные опухоли. 2021. Т. 11. № 3S2-2. С. 25-38. Vladimirova L. Yu., Gladkov O.A., Koroleva I.A., Rumyantsev A.A., Semiglazova T. Yu., Tryakin A.A., Kutukova S.I., Ovchinnikova E.G., Novikova O. Yu., Kornietskaya A.L. Practical recommendations for the prevention and treatment of nausea and vomiting in cancer patients. Malignant tumors. 2021. Vol. 11. No. 3S2-2. pp. 25-38.
27. Tytgat G.N., Mccoll K., Tack J. et al. New algorithm for the treatment of gastro-esophageal reflux disease. Aliment Pharmacol. Ther. 2008; 27: 249-56.
28. Шкляев А.Е., Казарин Д.Д., Горбунов Ю.В. Эффективность прокинетика итоприда при сахарным диабете 2 типа. Экспериментальная и клиническая гастроэнтерология. 2020; 181 (9): 35-39. DOI: 10.31146/1682-8658-ecg-181-9-35-39 Shklyaev A.E., Kazarin D.D., Gorbunov Yu.V. Efficacy of the prokinetic itopride in type 2 diabetes mellitus. Experimental and clinical gastroenterology. 2020; 181 (9): 35-39. DOI: 10.31146/1682-8658-ecg-181-9-35-39
29. Stevens J.E., Jones K.L., Rayner C.K., Horowitz M. Pathophysiology and pharmacotherapy of gastroparesis: current and future perspectives. Expert Opin Pharmacother. 2013 Jun; 14 (9): 1171-86.
30. Camilleri M., Parkman H.P., Shafi M.A., Abell T.L., Gerson L. American College of Gastroenterology. Clinical guideline: management of gastroparesis. Am.J. Gastroenterol. 2013 Jan; 108 (1): 18-37.
31. Masayuki N. et al. Effect of itopride hydrochloride on diabetic gastroparesis. Kiso to Rinsho. 1997; 31: 2785-91.
32. Sugumar A., Singh A., Pasricha P.J. A Systematic Review of the Efficacy of Domperidone for the Treatment of Diabetic Gastroparesis. Clin. Gastroenterol. Hepatol. 2008; 2: 123-35.
33. Буторова Л.И., Конькова Л.А., Левин В.И., Нугаева Н.Р., Палченкова М.В., Саютина Е.В. Роль прокинетиков в лечении гастроэзофагеальной рефлюксной болезни. Врач. 2022. Т. 33. № 3. С. 67-76. Butorova L. I., Konkova L. A., Levin V. I., Nugaeva N. R., Palchenkova M. V., Sayutina E.V. The role of prokinetics in the treatment of gastroesophageal reflux disease. Doctor. 2022. V. 33. No. 3. P. 67-76.
34. Trukhan D.I., Tarasova L.V. Pathogenetic therapy of functional dyspepsia and gastroesophageal reflux disease: selection of a prokinetic. Practical medicine. 2014; 1 (77): 147-52. Review (Russian).
35. Qi Z. Recent Data of Itopride in the Treatment of Functional Dyspepsia in Chinese Patients. Ganaton Regional Advisory Board Meeting Thailand. 2010; 3: 1-8.
36. Walwaikar P.P., Kulkarni S.S., Bargaje R.S. Evaluation of new gastrointestinal prokinetic (ENGIP-I) study. J. Indian Med. Assoc. 2005; 103 (10): 559-60.
37. Kim Y.S., Kim T.H., Choi C.S. et al. ENGIP-I study. Effect of itopride, a new prokinetic, in patients with mild GERD: a pilot study. World J. Gastroenterol. 2005; 11 (27): 4210-14.
38. Trukhan D.I., Tarasova L.V. Clinical, diagnosis and treatment of chronic duodenitis. Exp. Clin. Gastroenterol. 2012; (11): 104-14.
39. Lim H.C., Kim Y.G., Lim J.H., Kim H.S., Park H. Effect of itopride hydrochloride on the ileal and colonic motility in guinea pig in vitro. Yonsei Med. J. 2008 Jun 30; 49 (3): 472-8.
40. Kim H.J., Kim T.O., Shin B.C. et al. Efficacy of prokinetics with a split-dose of polyethylene glycol in bowel preparation for morning colonoscopy: A randomized controlled trial. Digestion. 2012; 86 (3): 194-200.
41. Trukhan D.I., Tarasova L.V., Grishechkina I.A. Prokinetics: Focus on itopride hydrochloride. Russ. Med. Bull. 2013; 3: 29-40.
42. Savant P., Das H.S., Desai N., et al. Comparative evaluation of the efficacy and tolerability of itopride hydrochloride and domperidone in patients with non-ulcer dyspepsia. JAPI 2004; 52: 626-28.
43. Lelyveld N., Linde J., Schipper M. Effect of itopride on gastric emptying in longstanding diabetes mellitus. J. Neurogastroenterol. Motil. 2008; 5 (20): 456-63.
44. Mishima Y., Amano Y., Okita K. et al. Efficacy of prokinetic agents in improving bowel preparation for colonoscopy. Digestion. 2008; 77 (3-4): 166-72.
45. Фоминых Ю.А., Гнутов А.А., Насыров Р.А., Калинина Е.Ю., Колгина Н.Ю. Особенности поражения пищевода при постхолецистэктомическом синдроме. Экспериментальная и клиническая гастроэнтерология. 2022; 198 (2): 121-130. DOI: 10.31146/1682-8658-ecg-198-2-121-130 Fominykh Yu.A., Gnutov A.A., Nasyrov R.A., Kalinina E. Yu., Kolgina N. Yu. Features of the lesion of the esophagus in postcholecystectomy syndrome. Experimental and Clinical Gastroenterology. 2022; 198 (2): 121-130. DOI: 10.31146/1682-8658-ecg-198-2-121-130
Review
For citations:
Babich A.E., Zubareva N.A., Ketova G.G. Priorities in choosing prokinetic for patients with functional dyspepsia: Focus on itopride. Medical alphabet. 2022;1(28):28-32. (In Russ.) https://doi.org/10.33667/2078-5631-2022-28-28-32
Views:
601
Email this article 