Itopride in the treatment of functional dyspepsia in Chinese patients: a prospective, multicentre, post-marketing observational study.

backgroundProkinetic agents are commonly used in the symptomatic treatment of functional dyspepsia (FD). Safety or efficacy issues associated with the use of available prokinetics, such as metoclopramide, domperidone, cisapride and mosapride, mean there is a need for an effective and well tolerated prokinetic agent. Itopride is a novel prokinetic agent with a dual mode of action, good safety profile and documented efficacy in placebo-controlled trials.

objectiveThe objective of this study was to assess the effectiveness and safety of itopride in the management of FD.

methodsThis was a prospective, multicentre, post-marketing observational study carried out in private outpatient clinics throughout China. The study included patients with symptomatic FD aged ≥18 years. Patients were prescribed itopride 50 mg three times daily before meals for 4 weeks, after which there was a 2-week follow-up period during which they did not take itopride. Effectiveness and tolerability data obtained from patients who completed 4 weeks of therapy were analysed. The treatment response rate after 4 weeks was measured by patient global assessment; scores at the end of treatment were compared with baseline scores. Response rate based on symptom scoring was also measured after 4 weeks, with an effective treatment being defined as a symptom improvement of ≥50%.

resultsIn total, 587 patients with FD were enrolled. The mean ± SD difference in the total symptom score before and after the 4-week treatment period was -5.62 ± 3.27, corresponding to a 69.23 ± 26.53% reduction from baseline (p < 0.001). The treatment response rates in patients who fulfilled Rome I, II and III criteria for FD were 33.68%, 34.71% and 35.50%, respectively, after 1 week of treatment; 52.82%, 54.61% and 56.51%, respectively, after 2 weeks; 66.67%, 67.23% and 68.64%, respectively, after 3 weeks; and 72.82%, 73.54% and 75.15%, respectively, after 4 weeks. Response rates were significantly different at 1 week versus 4 weeks of treatment. Nine patients (1.54%) had adverse events: four were probably related to the study drug, three were possibly related and two were not related. Of the nine patients with adverse events, two discontinued the study drug, two suspended (i.e. temporarily discontinued the drug until the adverse event subsided) the study drug, and five continued the study drug. Seven of the nine patients with adverse events had adverse reactions (defined as adverse events considered causally related to the study drug): two improved, three recovered and two showed no change. No adverse reactions were serious enough to warrant discontinuation of therapy.

conclusionItopride was an effective and well tolerated drug in the management of FD in this patient population.