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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