Cinitapride Extended-Release Tablets Versus Cinitapride Immediate-Release Tablets in the Treatment of Functional Dyspepsia and Gastroesophageal Reflux Disease : A Randomized Clinical Trial.

Prokinetics are commonly used for Functional Dyspepsia (FD) and GastroEsophageal Reflux Disease (GERD). Aims and Objectives: To evaluate the safety and efficacy of cinitapride Extended-Release (ER) tablets versus conventional cinitapride Immediate-Release (IR) tablets for the treatment of FD and GERD. Materials and Methods: Patients with FD and GERD received either cinitapride ER 3 mg tablets OD or cinitapride IR 1 mg tablets TID for 4 weeks in this randomized, multicentre study. Change in the mean intensity score of gastrointestinal (GI) symptoms (overall and individual) at the end of the study and at each weekly follow up visit as compared to baseline, patients with complete resolution of GI symptoms, patients with > 50% reduction from baseline in overall intensity score, rescue medication use and overall efficacy were recorded. The safety variables were reported adverse events (AEs), laboratory parameters, electrocardiogram, and overall tolerability. Unpaired t test, chi square test or Fisher’s exact test were used for analysis. p < 0.05 was considered significant. Results: Total 218 patients were enrolled Cinitapride ER tablets were non-inferior (non-inferiority margin -2.5) to cinitapride IR tablets for the change in the mean overall GI symptom intensity score at the end of the study as compared to the baseline (treatment difference - 0.2 (95% CI: -2.2, 1.7)); also, no significant difference was found for other efficacy variables (p > 0.05). Eight AEs of mild-to-moderate intensity were reported. There was also no difference in the overall tolerability between the study groups (p = 0.875). Conclusions : Both the study treatments were comparable in terms of safety and efficacy for the treatment of FD and GERD.

Efeito antiemético da alizaprida: avaliaçäo multicêntrica de 1.945 casos / Antiemetic effect of alizapride: a multicenter evaluation of 1,945 cases

Através de um estudo aberto, multicêntrico, envolvendo 1.945 pacientes, foram avaliadas a eficácia clínica, a segurança e a tolerabilidade da alizaprida, o mais recente antiemético da série das benzamidas substituídas. A droga demonstrou ser dotada de atividade específica sobre os receptores dopaminérgicos, rapidez de açäo, segurança e excelente tolerabilidade. Foram avaliados os resultados globais, tanto em termos de eficácia clínica como de tolerabilidade. A eficiência do medicamento foi considerada excelente ou boa em mais de 95% dos casos. A tolerância ao medicamento foi da ordem de 97% e os efeitos secundários e/ou indesejáveis näo foram muito freqüentes, nem intensos na maioria das vezes