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Aliment Pharmacol Ther ; 23(11): 1655-65, 2006 Jun 01.
Artículo en Inglés | MEDLINE | ID: mdl-16696817

RESUMEN

AIM: To investigate the efficacy and safety of renzapride, a potent 5-hydroxytryptamine type-4 receptor full agonist and 5-hydroxytryptamine type-3 receptor antagonist in patients with constipation-predominant irritable bowel syndrome. METHODS: In this dose-escalating pilot study, 17 patients with constipation-predominant irritable bowel syndrome received placebo, renzapride 2 mg o.d. and renzapride 2 mg b.d. sequentially for 28 days. Response was determined by radio-opaque marker measurement of overall gastrointestinal and segmental colonic transit and patients' assessment of their irritable bowel syndrome symptoms. RESULTS: Renzapride reduced mean overall gastrointestinal transit time (placebo, 2.9 +/- 1.6 days; renzapride 2 mg o.d., 2.6 +/- 1.4 days; renzapride 2 mg b.d., 1.9 +/- 1.6 days) (P = 0.024) and accelerated segmental colonic transit, with statistically significant differences for renzapride 2 mg b.d. over placebo in caecum/ascending colon (P = 0.019) and descending colon (P = 0.022). Renzapride also reduced abdominal pain, increased the number of pain-free days and improved stool consistency. The frequency of reported adverse events was similar on renzapride and placebo. CONCLUSIONS: Renzapride is well-tolerated, stimulates gastrointestinal transit and improves symptoms in patients with constipation-predominant irritable bowel syndrome, particularly at the 2 mg b.d. dose, where improvements in gastrointestinal symptoms were evident over placebo. This study has established proof of concept and supports further investigation of renzapride in patients with constipation-predominant irritable bowel syndrome.


Asunto(s)
Benzamidas/uso terapéutico , Compuestos Bicíclicos Heterocíclicos con Puentes/uso terapéutico , Estreñimiento/tratamiento farmacológico , Síndrome del Colon Irritable/tratamiento farmacológico , Antagonistas de la Serotonina/uso terapéutico , Adulto , Benzamidas/efectos adversos , Compuestos Bicíclicos Heterocíclicos con Puentes/efectos adversos , Relación Dosis-Respuesta a Droga , Femenino , Motilidad Gastrointestinal/efectos de los fármacos , Humanos , Masculino , Persona de Mediana Edad , Proyectos Piloto , Antagonistas de la Serotonina/efectos adversos , Método Simple Ciego , Resultado del Tratamiento
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