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

Abstract

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.

• Authors: C L Chen, W C Orr, M H Verlinden, A Dettmer, H Brinkhoff, D Riff, S Schwartz, R D Soloway, R Krause, F Lanza, R J Mack
• Journal: Alimentary pharmacology & therapeutics (Aliment Pharmacol Ther) Vol. 16 Issue 4 Pg. 749-57 (Apr 2002) ISSN: 0269-2813 [Print] England
• PMID: 11929393 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Receptors, Gastrointestinal Hormone
• Receptors, Neuropeptide
• motilin receptor
• Alemcinal
• Erythromycin

Topics

• Dose-Response Relationship, Drug
• Double-Blind Method
• Erythromycin (analogs & derivatives, therapeutic use)
• Female
• Gastroesophageal Reflux (drug therapy)
• Humans
• Male
• Quality of Life
• Receptors, Gastrointestinal Hormone (agonists)
• Receptors, Neuropeptide (agonists)
• Surveys and Questionnaires
• Treatment Outcome