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.

LESSA [Lebanese short-term Study with Amisulpride] study. A phase IV clinical trial in acutely ill schizophrenic patients

Background Conventional antipsychotics have relatively moderate efficacy against schizophrenic negative symptoms and are associated with significant adverse events. Objectives To assess the clinical safety and efficacy of Solian[R] [amisulpride], an atypical antipsychotic agent of the benzamide family. Patients and methods: This is an 8-week cohort study including adults with schizophrenia. Daily dose was between 400 and 800 mg. Safety was measured as the cumulative risk of adverse events and efficacy as the physician's global assessment of global improvement on an ordinal scale from 0 to 6. An efficacy index, a composite measure of both safety and efficacy, was also measured on an ordinal scale from 16 the worst to 1 the best. Results Fifty-seven patients were included. Eight patients [14%] experienced at least one adverse event during the trial, mainly extra-pyramidal symptoms [EPS]. None required treatment discontinuation and none was qualified as serious. Four required corrective treatment and six resolved during the 8-week follow-up. On the Global Improvement scale 31.6% of patients were very much or much improved on D14 and 81.8% on D56. 25.5% of subjects achieved complete remission over the study period. Improvement reflected also on the efficacy index, decreasing from 8.2 [SD: 3.1] on D14 to 3.4 [SD: 2.9] on D56. Conclusion: Amisulpride, in addition to its well-established efficacy in schizophrenic patients, offers a particularly good safety profile