Age, Sex, and Comedication Effects on the Steady-State Plasma Concentrations of Amisulpride in Chinese Patients with Schizophrenia.

BACKGROUND

Amisulpride, a second-generation atypical antipsychotic drug, was first marketed in Europe in the 1990s. This study aimed to provide a reference for the clinical application of amisulpride. The effects of age, sex, or specific comedications on amisulpride concentrations in Chinese patients with schizophrenia in the real world were investigated.

METHODS

A retrospective study was conducted of data on amisulpride based on the therapeutic drug monitoring service database at the Zigong Affiliated Hospital of Southwest Medical University.

RESULTS

Based on the inclusion criteria, 195 plasma samples from 173 patients (67.05% female and 32.95% male patients) were included for in-depth analysis. The median daily dose of amisulpride was 400 mg/d, median plasma concentration was 457.50 ng/mL, and median concentration/dose (C/D) ratio was 1.04 ng/mL/mg/d. The daily dose of amisulpride positively correlated with measured steady-state plasma concentrations. A significant difference was observed in the subgroup analysis of the combination with valproic acid, zopiclone, or aripiprazole on plasma concentrations. Combining amisulpride with these drugs increased the C/D ratios by 0.56-, 2.31-, and 0.77-fold, respectively. After adjusting for age, the median C/D ratio was found to be significantly different between female and male patients. However, no significant differences in daily dose, plasma concentration, and C/D ratio were noted with respect to sex and age of the patients.

CONCLUSIONS

Sex differences were inferred for the first time in this study, with differential effects on daily dose, steady-state plasma concentration, and C/D ratio associated with the population. In the included study samples, blood concentrations were distributed in the range of 223.25-823.55 ng/mL, which perhaps needs to be evaluated in line with the reference range of ammonia-sulfur ratios in the Chinese population.