Efficacy of mitemcinal, a motilin agonist, on gastrointestinal symptoms in patients with symptoms suggesting diabetic gastropathy: a randomized, multi‐center, placebo‐controlled trial
- 20 April 2007
- journal article
- research article
- Published by Wiley in Alimentary Pharmacology & Therapeutics
- Vol. 26 (1), 107-116
- https://doi.org/10.1111/j.1365-2036.2007.03346.x
Abstract
Mitemcinal, an oral motilin agonist, accelerates gastric emptying. To investigate if mitemcinal was superior to placebo in relief of symptoms attributed to gastroparesis. In a randomized, double-blind design, 392 insulin-requiring diabetics with symptoms attributable to gastroparesis were treated for 3 months with placebo, mitemcinal 5 or 10 mg bid. On a weekly basis, patients assessed whether there was adequate relief of their gastroparesis symptoms. Patients were classified as Complete Responders (CR) if there were three consecutive positive monthly responses, which required at least 50% of their weekly responses in a month being positive. An Overall Responder (OR) had at least 75% positive weekly responses for the whole treatment period. Mitemcinal 10 mg produced a significantly better response rate than placebo with a 10.6% increase in the OR (P < 0.05 vs. placebo). Mitemcinal 10 mg also produced statistically significant increases in the CR and OR in the subgroup identified by baseline body mass index (<35 kg/m(2)) and haemoglobin A(1c) (<10%) (P < 0.01 vs. placebo). Adverse events did not differ from placebo frequency levels. Mitemcinal can induce a statistically significant response to treatment in a subset of diabetic gastroparesis where future prokinetic clinical trials should be focused.Keywords
This publication has 15 references indexed in Scilit:
- Treatment of gastroparesis: a multidisciplinary clinical reviewNeurogastroenterology & Motility, 2006
- Oral Erythromycin and the Risk of Sudden Death from Cardiac CausesThe New England Journal of Medicine, 2004
- Obesity is Associated with Increased Risk of Gastrointestinal Symptoms: A Population-Based StudyThe American Journal of Gastroenterology, 2004
- Effects of a motilin receptor agonist (ABT-229) on upper gastrointestinal symptoms in type 1 diabetes mellitus: a randomised, double blind, placebo controlled trialGut, 2001
- Failure of a motilin receptor agonist (ABT‐229) to relieve the symptoms of functional dyspepsia in patients with and without delayed gastric emptying: a randomized double‐blind placebo‐controlled trialAlimentary Pharmacology & Therapeutics, 2000
- ERYTHROMYCIN DERIVATIVES ABT 229 AND GM 611 ACT ON MOTILIN RECEPTORS IN THE RABBIT DUODENUMClinical and Experimental Pharmacology and Physiology, 1999
- Cisapride and erythromycin prokinetic effects in gastroparesis due to type 1 (insulin‐dependent) diabetes mellitusAlimentary Pharmacology & Therapeutics, 1997
- Effect of Motilin on Gastric Emptying in Patients With Diabetic GastroparesisDiabetes Care, 1991
- Improvement of Gastric Emptying in Diabetic Gastroparesis by ErythromycinThe New England Journal of Medicine, 1990
- Erythromycin is a motilin receptor agonistAmerican Journal of Physiology-Gastrointestinal and Liver Physiology, 1989