TY - JOUR
T1 - Efficacy of a motilin receptor agonist (ABT-229) for the treatment of gastro-oesophageal reflux disease
AU - Chen, C. L.
AU - Orr, W. C.
AU - Verlinden, M. H.
AU - Dettmer, A.
AU - Brinkhoff, H.
AU - Riff, D.
AU - Schwartz, S.
AU - Soloway, R. D.
AU - Krause, R.
AU - Lanza, F.
AU - Mack, R. J.
PY - 2002
Y1 - 2002
N2 - 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.
AB - 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.
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U2 - 10.1046/j.1365-2036.2002.01218.x
DO - 10.1046/j.1365-2036.2002.01218.x
M3 - Article
C2 - 11929393
AN - SCOPUS:0036109729
SN - 0269-2813
VL - 16
SP - 749
EP - 757
JO - Alimentary Pharmacology and Therapeutics
JF - Alimentary Pharmacology and Therapeutics
IS - 4
ER -