Efficacy of Itopride in Treatment of Gastroparesis Considering the State of Carbohydrate Metabolism in Patients with Type 2 Diabetes Mellitus

Introduction. At present, despite the continuous advancement in medical science pathogenetic mechanisms of the development and progression of gastrointestinal form of autonomic neuropathy, particularly one of its manifestations – diabetic gastroparesis (DG) remains insufficiently studied. Purpose of the study. To determine therapeutic efficacy of itopride in treatment of DG considering the state of carbohydrate metabolism in patients with type 2 diabetes mellitus. Materials and methods. There were examined 48 patients with type 2 DM, divided into two groups. The standard 6-week course of pathogenetically grounded therapy patients of Group I (n = 24) received itopride hydrochloride at a daily dose of 150 mg (50 mg three times a day 30 min before their main meal). Patients of Group II (the control group) (n = 24) underwent the standard therapy without using medicines affecting MEF of the stomach. The clinical severity of DG was determined using the questionnaire ″Patient Assessment of Gastrointestinal Disorders-Symptom Severity Index″ (PAGI-SYM). According to the survey (D-ABS) the prevalence and intensity of the hypoglycemic episodes were determined. To assess MEF of the stomach all the patients underwent 13C-octanoic acid breath test. Results and discussion. According to the results of additional methods of examination there was a direct correlation between the mean PAGI-SYM scores and the results of 13C-octanoic acid breath test (r = 0.63 ± 0.03, p < 0.001). There was also a strong direct correlation between the state of compensation of carbohydrate metabolism (НbA1C, %) and the degree of slowing of gastrointestinal motility according to the results of 13C-octanoic acid breath test (r = 0.64 ± 0.03, p < 0.001). Thus, the course of DG depends on the effectiveness of glycemic control. Total PAGI-SYM scores indicated the positive effect of treatment which was significantly different in patients of Group I before (14.21 ± 3.28 points – moderate DG) and after the treatment (7.28 ± 0.9 points – mild DG) compared to the control group. The results of 13C-octanoic acid breath test confirmed the effectiveness of a 6-week course of treatment with itopride hydrochloride at a daily dose of 150 mg (50 mg three times a day 30 min before a meal) with recovery of gastrointestinal motility (according to treatment Т ½ – 98.24 ± 3.14 min, in dynamics Т ½ – 68.32 ± 3.55 min; р < 0.05) in patients of Group I. In patients of Group II (the control group) the normalization of MEF of the stomach after the course of treatment was not observed (before treatment Т ½ – 97.23 ± 2.61 min, after treatment Т ½ – 92.12 ± 0.16 min; р >0.05). Conclusions. The effectiveness of using itopride hydrochloride at a daily dose of 150 mg has been proven. It has been established that it contributes to normalizing MEF of the stomach in patients with type 2 DM and signs of DG as well as achieving better compensation of carbohydrate metabolism of both prandial and postprandial glucose levels.