Itopride in functional dyspepsia: results of two phase III multicentre, randomised, double-blind, placebo-controlled trials.
BACKGROUND
Functional dyspepsia (FD) is a common disorder but there is currently little efficacious drug therapy. Itopride, a prokinetic approved in several countries, showed promising efficacy in FD in a phase IIb trial. The aim of this study was to test the efficacy and safety of this drug in FD.


METHODS
Two similar placebo-controlled clinical trials were conducted (International and North America). Males and females, 18-65 years old, with a diagnosis of FD (Rome II) and the absence (by upper endoscopy) of any relevant structural disease were recruited. All were negative for Helicobacter pylori and, if present, heartburn could not exceed one episode per week. Following screening, patients were randomised to itopride 100 mg three times daily or identical placebo. The co-primary end points were: (1) global patient assessment (GPA) of efficacy; and (2) Leeds Dyspepsia Questionnaire (LDQ). Symptoms were evaluated at weeks 2, 4 and 8. Secondary measures of efficacy included Nepean Dyspepsia Index (NDI) quality of life.


RESULTS
The GPA responder rates at week 8 on itopride versus placebo were similar in both trials (45.2% vs 45.6% and 37.8 vs 35.4%, respectively; p = NS). A significant benefit of itopride over placebo was observed for the LDQ responders in the International (62% vs 52.7%, p = 0.04) but not the North American trial (46.9% vs 44.8%). The safety and tolerability profile were comparable with placebo, with the exception of prolactin elevations, which occurred more frequently on itopride (18/579) than placebo (1/591).


CONCLUSIONS
In this population with FD, itopride did not show a difference in symptom response from placebo.
Talley
N J
NJ
Mayo Clinic College of Medicine, Department of Internal Medicine, 4500 San Pablo Road, Jacksonville, FL 32082, USA. talley.nicholas@mayo.edu
Tack
J
J
Ptak
T
T
Gupta
R
R
Giguère
M
M
D000293:Adolescent; D000328:Adult; D000368:Aged; D001549:Benzamides / Q000009:adverse effects / Q000627:therapeutic use*; D001593:Benzyl Compounds / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004415:Dyspepsia / Q000188:drug therapy*; D005260:Female; D005765:Gastrointestinal Agents / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance; D017060:Patient Satisfaction; D011788:Quality of Life; D012720:Severity of Illness Index; D016896:Treatment Outcome
D001549:Benzamides; D001593:Benzyl Compounds; D005765:Gastrointestinal Agents; C102254:itopride