[Efficacy and tolerance of cinitapride on the disturbances of gastrointestinal transit].
In order to evaluate the efficacy and tolerance of cinitapride, 103 patients with gastrointestinal disorders were admitted to a randomized, parallel, double blind trial for treatment with cinitapride, metoclopramide or placebo. Cinitapride was significantly more effective than metoclopramide in restoring normal defecation rates in constipated patients after 7 and 14 days of treatment (p = 0.036 and p = 0.008) and significantly more effective than placebo in restoring normal consistency of compact stools after 7 and 14 days of treatment (p = 0.006 and p = 0.051). Cinitrapide also proved to be significantly more effective than metoclopramide in curing or improving post-prandial epigastric distention (p = 0.031), post-prandial epigastric fullness (p = 0.037) and abdominal pain (p = 0.002) after 7 and 14 days of treatment. After treatment with cinitapride, dyspeptic symptoms disappeared or improved in 56-82% of patients. The efficacy rates in controlling gastrointestinal transit disorders, according to the investigators, were 64% for cinitapride, 28% for metoclopramide (p = 0.004) and 39% for placebo (p = 0.031) and, according to the patients, 55% for cinitapride, 25% for metoclopramide (p = 0.014) and 39% for placebo, 44% of the patients treated with cinitapride, 51% of the patients treated with metoclopramide and 26% of the patients treated with placebo reported and adverse reaction, with statistically significant differences between metoclopramide and placebo (p = 0.031). The tolerance rates, according to the investigators, were 82% for cinitapride, 64% for metoclopramide and 94% for placebo (placebo vs. metoclopramide, p = 0.001) and, according to the patients, 72% for cinitapride, 51% for metoclopramide and 89% for placebo (placebo vs. metoclopramide, p = 0.001).(ABSTRACT TRUNCATED AT 250 WORDS)
Gallego Santos
J
J
Servicio de Medicina Interna, Hospital Miraflores, Facultad de Medicina, Universidad de Sevilla.
Fombuena Filpo
J
J
Martínez López
J
J
D000328:Adult; D001549:Benzamides / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D005767:Gastrointestinal Diseases / Q000188:drug therapy*; D005772:Gastrointestinal Transit / Q000187:drug effects*; D006801:Humans; D008297:Male; D008787:Metoclopramide / Q000627:therapeutic use; D008875:Middle Aged
D001549:Benzamides; D008787:Metoclopramide; C045316:cinitapride
Eficacia y tolerancia de cinitaprida en trastornos del tránsito gastrointestinal.