Use of itopride in the symptoms of functional dyspepsia in Russia: Results of a Phase IV prospective open-label multicenter clinical trial


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Abstract

AIM. To evaluate the efficacy and safety of itopride used to treat the symptoms of functional dyspepsia (FD) of the upper gastrointestinal tract. MATERIALS AND METHODS. A prospective, open-label, multicenter trial using as a control the placebo response obtained in the previous investigations enrolled 96 adult patients. The diagnosis of FD corresponded to its Rome II criteria. Patients received itopride (Ganaton) oral tablets (50 mg) 3 times daily for 8 weeks. When included into the trial, the patients were orally given itopride (ganaton) tablets (50 mg) thrice daily before meals for 8 weeks. The patients' status was evaluated during (at weeks 4 and 8) and after (at week 12) treatment. Treatment response was assessed using the Global Patient Assessment (GPA) and the Leeds Dyspepsia Questionnaire (LDQ). To evaluate the safety of itopride use, the investigators studied the frequency of adverse events and carried out laboratory tests (renal and liver function tests) and electrocardiography (ECG). RESULTS. The GPA showed that 53.76, 85.71, and 82.22% of the patients achieved a therapeutic effect of itopride at weeks 4, 8, and 12, respectively. The proportion of the patients who achieved the therapeutic effect (86%) at week 8 was higher than the historical placebo controls in the previous studies - 45% (86% vs 45%; χ2=68.868, df=3; p<0.001). The mean LDQ score at week 8 was significantly lower than that at baseline (2.09 and 9.36 scores; p<0.001); 6 nonserious adverse events occurred in 3 (3.12%) of the 96 patients. During the follow-up period, there was a mild adverse event that was related to the test drug (atrial extrasystole as evidenced by ECG) and resolved a few days later. CONCLUSION. Itopride is an effective and well-tolerated drug in the treatment of functional dyspepsia in the Russian patients.

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Применение итоприда при симптомах функциональной диспепсии в России: результаты проспективного открытого многоцентрового клинического исследования IV фазы. - Резюме. Цель исследования. Оценка эффективности и безопасности применения итоприда для лечения симптомов функциональной диспепсии (ФД) верхних отделов желудочно-кишечного тракта. Материалы и методы. В проспективное открытое многоцентровое исследование, в котором в качестве контроля использовался ответ на плацебо, полученный в предыдущих исследованиях, включили 96 взрослых пациентов. Диагноз ФД соответствовал Римским критериям II. При включении в исследование пациентам назначали итоприд (Ганатон) в виде таблеток для приема внутрь (50 мг) 3 раза в день до еды на протяжении 8 нед. Оценку состояния проводили во время лечения (на 4-й и 8-й неделях) и после окончания лечения (на 12-й неделе). Ответ на лечение оценивали при помощи Глобальной оценки состояния пациентом (Global Patient Assessment - GPA) и Лидсовского опросника диспепсии (Leeds Dyspepsia Questionnaire - LDQ). С целью оценки безопасности применения итоприда изучали частоту нежелательных явлений, а также проводили лабораторные исследования (тесты функции печени и почек) и электрокардиографию. Результаты. Лечебный эффект при приеме итоприда на 4, 8 и 12-й неделях по данным GPA достигнут у 53,76, 85,71 и 82,22% больных соответственно. Доля пациентов, у которых на 8-й неделе достигнут лечебный эффект (86%), была больше, чем в историческом плацебо-контроле из предшествующих исследований - 45% (86% против 45%; χ2=68,868, df=3; р<0,001). Средняя оценка по LDQ на 8-й неделе была значительно меньше, чем в начале исследования (2,09 и 9,36 балла; р<0,001); 6 незначительных нежелательных явлений возникло у 3 из 96 (3,12%) пациентов. Во время наблюдения обнаружено одно легкое нежелательное явление, связанное с исследуемым лекарственным препаратом (предсердная экстрасистолия по данным электрокардиографии), которое купировалось через несколько дней. Заключение. Итоприд - эффективный и хорошо переносимый препарат для лечения ФД у российских пациентов.
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References

  1. Tack J., Talley N.J., Camilleri M. et al. Functional gastroduodenal disorders. Gastroenterology 2006; 130: 1466-1479.
  2. Talley N.J., Stanghellini V., Heading R.C. et al. Functional gastroduodenal disorders. Gut 1999; 45 (Suppl II): II37-II42.
  3. Jones R.H., Lydeard S. Prevalence of symptoms of dyspepsia in the community. BMJ 1989; 298: 30-32.
  4. Penston J.G., Pounder R.E. A survey of dyspepsia in Great Britain. Aliment Pharmacol Ther 1996; 10: 83-89.
  5. Moayyedi P., Mason J. Clinical and economic consequences of dyspepsia in the community. Gut 2002; 50 (Suppl IV): iv10-iv12.
  6. Talley N.J., Locke G.R. 3rd, Lahr B.D. et al. Functional dyspepsia, delayed gastric emptying, and impaired quality of life. Gut 2006; 55 (7): 933-939.
  7. Filipovic B.F., Randjelovic T., Ille T. et al. Anxiety, personality traits and quality of life in functional dyspepsia-suffering patients. Eur J Intern Med 2013; 24: 83-86.
  8. Holtmann G., Talley N.J., Liebregts T. et al. A Placebo-Controlled Trial of Itopride in Functional Dyspepsia. New Engl J Med 2006; 354: 832-840.
  9. Talley N.J., Tack J., Ptak T. et al. Itopride in functional dyspepsia: results of two phase III multicentre, randomised, double-blind, placebo-controlled trials. Gut 2008; 57: 740-746.
  10. Tsuchihara M., Suga T., Murashima Y. et al. Therapeutic effect of itopride hydrochloride on non-specific gastrointestinal complaints in chronic gastritis patients. J New Remedies & Clinics 1993; 42 (12): 2459-2465.
  11. Sibuya D., Sakurada H. Clinical evaluation of Itopride hydrochloride for upper abdominal digestive symptoms associated with chronic gastritis. Med Consult New Remed 1993; 30 (11): 2125-2131.
  12. Mo J.Z., Li D.G., Jiang J.H. et al. A multi-center clinical trial of itopride hydrochloride in the treatment of functional dyspepsia. Zhongguo Xinyao Zazhi 2003; 12: 467-469.
  13. Zhou L.Y., Li B.C., Lin S.L. et al. A Multi-centre Clinical Trial on Itopride Hydrochloride for Treatment of Functional Dyspepsia. Zhongguo Linchuang Yaolixue Zazhi 2000; 16: 403-407.
  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; 31 (12): 865-875.
  15. Veldhuyzen zan Zanten S.J.O., Talley N.J., Bytzer P. et al. Design of treatment trials for functional gastrointestinal disorders. Gut 1999; 45 (Suppl II): II69-II77.
  16. Moayyedi P., Duffet S., Braunholtz D. et al. The Leeds Dyspepsia Questionnaire: a valid tool for measuring the presense and severity of dyspepsia. Aliment Pharmacol Ther 1998; 12: 1257-1262.
  17. Sleisenger and Fordtran`s gastrointestinal and liver disease: pathophysiology, diagnosis, management. M. Feldman, L.S. Friedman, L.J. Brandt (eds). 9th ed. Philadelphia: Saunders 2010: 809.
  18. Parkman H.P., Miller M.A., Trate D. et al. Electrogastrography and gastric emptying scintigraphy are complementary for assessment of dyspepsia. J Clin Gastroenterol 1997; 24: 214-219.
  19. Iwanaga Y., Miyashita N., Saito T. et al. Gastroprokinetic effect of a new benzamide derivative itopride and its action mechanisms in conscious dogs. Jpn J Pharmacol 1996; 71: 129-137.
  20. Iwanaga Y., Miyashita N., Morikawa K. et al. A novel water-soluble dopamine-2-antagonist with anticholinesterase activity in gastrointestinal Motor activity. Gastroenterology 1990; 99: 401-408.
  21. Choung R.S., Talley N.J., Peterson J. et al. A double-blind, randomized, placebo-controlled trial of itopride on gastric motor and sensory function in healthy volunteers. Neurogastroenterol Motil 2007; 19: 180-187.
  22. Gupta S., Kapoor V., Kapoor B. Itopride: A Novel Prokinetic Agent. JK Science 2004; 6 (2): 106-108.
  23. Kakiuchi M., Saito T., Ohara N. et al. Pharmacological Evaluation of itopride hydrochloride with drug-induced arrhythmia. Jpn Pharmacol Ther 1997; 25 (3): 811-817.
  24. Huang X., Lv B., Zhang S. et al. Itopride therapy for functional dyspepsia: A meta-analysis. World J Gastroenterol 2012; 18 (48): 7371-7377.

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