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.


OBJECTIVE
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.


CONCLUSIONS
ABT-229 appears to have limited, if any, clinical utility in the treatment of gastro-oesophageal reflux disease.
Chen
C L
CL
Lynn Institute for Healthcare Research, Oklahoma City, OK 73112, USA.
Orr
W C
WC
Verlinden
M H
MH
Dettmer
A
A
Brinkhoff
H
H
Riff
D
D
Schwartz
S
S
Soloway
R D
RD
Krause
R
R
Lanza
F
F
Mack
R J
RJ
D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004917:Erythromycin / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D005260:Female; D005764:Gastroesophageal Reflux / Q000188:drug therapy*; D006801:Humans; D008297:Male; D011788:Quality of Life; D011964:Receptors, Gastrointestinal Hormone / Q000819:agonists*; D018013:Receptors, Neuropeptide / Q000819:agonists*; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
D011964:Receptors, Gastrointestinal Hormone; D018013:Receptors, Neuropeptide; C050802:motilin receptor; C114264:Alemcinal; D004917:Erythromycin