[Efficacy and tolerability of cinitapride in the treatment of functional dyspepsia and delayed gastric emptying].
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 1mg 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.
Portincasa
Piero
P
Departamento de Medicina Interna y Salud Pública, Facultad de Medicina, Universidad de Bari, Bari, Italy.
Mearin
Fermin
F
Robert
Marta
M
Plazas
M Josep
MJ
Mas
Marta
M
Heras
Joan
J
D000328:Adult; D000368:Aged; D001549:Benzamides / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D003199:Computer Systems; D018592:Cross-Over Studies; D065127:Dopamine D2 Receptor Antagonists; D004311:Double-Blind Method; D004415:Dyspepsia / Q000188:drug therapy*; D004562:Electrocardiography / Q000187:drug effects; D005260:Female; D005746:Gastric Emptying / Q000187:drug effects*; D018589:Gastroparesis / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000503:physiopathology; D006801:Humans; D008297:Male; D008875:Middle Aged; D011706:Pyloric Antrum / Q000000981:diagnostic imaging / Q000503:physiopathology; D058830:Serotonin 5-HT2 Receptor Antagonists; D058828:Serotonin 5-HT4 Receptor Agonists; D018490:Serotonin Agents / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D014463:Ultrasonography; D055815:Young Adult
D001549:Benzamides; D065127:Dopamine D2 Receptor Antagonists; D058830:Serotonin 5-HT2 Receptor Antagonists; D058828:Serotonin 5-HT4 Receptor Agonists; D018490:Serotonin Agents; C045316:cinitapride