Efficacy and tolerability of cinitapride in the treatment of functional dyspepsia and delayed gastric emptying

Introduction and objective: Functional dyspepsia is a highly common disorder. The physiopathological mechanisms of this entity are not yet completely known and prokinetic drugs seem to be useful. The aim of this study was to evaluate the prokinetic effect of cinitapride in patients with dysmotility-like dyspepsia and delayed gastric emptying. Methods: Nineteen patients were randomized to receive 1 mg of an oral solution of cinitapride t.i.d or placebo for 4 weeks in two consecutive periods, following a crossover and double-blind design. The main variable was the mean change from baseline after 4 weeks of treatment in gastric-emptying half-time after a liquid test meal, measured by real-time ultrasonography. Results: At the end of treatment, the mean gastric-emptying half-time decreased with both treatments, with no statistically significant differences between them (ANOVA, p = 0.8720). This decrease was greater for cinitapride than for placebo (ANOVA, p = 0.0169) in patients with mild-to-moderate delayed gastric emptying. In this group of patients, cinitapride was also superior to placebo in the percentage AUC of the antral area and the percentage of days free of nausea. Cinitapride was well tolerated, with a safety profile comparable to that of placebo. Conclusions: Oral cinitapride is safe and effective in improving gastric emptying and symptoms in patients with dysmotility-like dyspepsia and mild-to-moderate delayed gastric emptying. (C) 2008 Elsevier Espana, S.L. All rights reserved.