Efficacy of a motilin receptor agonist (ABT‐229) for the treatment of gastro‐oesophageal reflux disease

Background: ABT‐229 is a potent motilin agonist without significant antibiotic activity. It has been shown to improve gastric emptying in humans and to increase lower oesophageal sphincter pressure in cats. Aim: To assess the efficacy of four different doses of ABT‐229 (1.25 mg, 2.5 mg, 5 mg, 10 mg...

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Bibliographic Details
Published in:Alimentary pharmacology & therapeutics 2002-04, Vol.16 (4), p.749-757
Main Authors: Chen, C. L., Orr, W. C., Verlinden, M. H., Dettmer, A., Brinkhoff, H., Riff, D., Schwartz, S., Soloway, R. D., Krause, R., Lanza, F., Mack, R. J.
Format: Article
Language:English
Subjects:
Biological and medical sciences
Digestive system
Dose-Response Relationship, Drug
Double-Blind Method
Erythromycin - analogs & derivatives
Erythromycin - therapeutic use
Female
Gastroesophageal Reflux - drug therapy
Humans
Male
Medical sciences
Pharmacology. Drug treatments
Quality of Life
Receptors, Gastrointestinal Hormone - agonists
Receptors, Neuropeptide - agonists
Surveys and Questionnaires
Treatment Outcome
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Summary:Background: ABT‐229 is a potent motilin agonist without significant antibiotic activity. It has been shown to improve gastric emptying in humans and to increase lower oesophageal sphincter pressure in cats. Aim: To assess the efficacy of four different doses of ABT‐229 (1.25 mg, 2.5 mg, 5 mg, 10 mg b.d.) compared to placebo in the treatment of gastro‐oesophageal reflux disease, and to determine its safety in patients with gastro‐oesophageal reflux disease. Methods: In a double‐blind, multicentre study, 324 patients with heartburn were randomized to receive four different doses of ABT‐229 or placebo for 8 weeks. The efficacy was evaluated by Patient Symptom Questionnaire, daily diary, endoscopy and global evaluation of efficacy. Results: There were no statistically significant improvement scores for any of the ABT‐229 treatment groups vs. the placebo group in any of the efficacy parameters. Reflux symptom scores were significantly worse after treatment in the dyspeptic group. ABT‐229 appeared to be well tolerated and safe in total daily doses up to 20 mg. Conclusion: ABT‐229 appears to have limited, if any, clinical utility in the treatment of gastro‐oesophageal reflux disease.
ISSN:0269-2813
1365-2036
DOI:10.1046/j.1365-2036.2002.01218.x