Effect of Itopride Hydrochloride on Gastric Emptying in Longstanding Diabetes Mellitus

Abstract

Purpose: Delayed gastric emptying (GE) occurs in 30–50% of patients with longstanding type 1 or type 2 diabetes mellitus and may be associated with upper gastrointestinal (GI) symptoms and poor glycemic control. Current therapeutic options are limited. Itopride has been tested in functional dyspepsia (NEJM 2006; 23; 354: 832). The aim of this study was to evaluate the effect of itopride on GE in diabetes. Methods: Twenty five patients (20 type 1, 5 type 2; 10M, 15 F; mean age 45.2 ± 2.7 yr; BMI 27.5 ± 0.9 kg/m2; duration 20.2 ± 2.4 yr) were enrolled in a double-blind, placebo-controlled, randomized, crossover trial; 15 had autonomic neuropathy (3.0 ± 0.2). Patients received both itopride (200 mg tid) and placebo for 7 days, separated by 7–14 days. GE was assessed by scintigraphy immediately following each treatment period. Autonomic nerve function (cardiovascular reflex tests) was assessed at enrolment. The test meal comprised 100g ground beef labeled with 20MBq 99mTc-sulfur colloid and 150 ml 10% dextrose labeled with 7MBq 67Ga-EDTA. Results: There was a trend for itopride to accelerate both solid (p= 0.09) and liquid (p= 0.09) GE. Of the 25 patients, 12 (48%) had gastroparesis (ie delayed solid and/or liquid GE) on placebo and in this group, itopride accelerated liquid (p < 0.05) but not solid (p= 0.39) GE. The magnitude of improvement in GE of liquids (r = 0.44; p < 0.03) and solids (r = 0.39; p= 0.057) was related to GE on placebo (Figure).Figure 1Conclusions: Itopride accelerates GE of liquids, and possibly solids, in diabetic gastroparesis, however, the magnitude of this effect appears to be relatively modest and dependent on the basal rate of GE. [Figure 1]