Amisulpride steady-state plasma concentration and adverse reactions in patients with schizophrenia: a study based on therapeutic drug monitoring data

Abstract

The aim of the study was to evaluate the reference range of amisulpride for Chinese patients with schizophrenia and to assess its possible influencing factors based on therapeutic drug monitoring information. The relative adverse reactions of patients induced by amisulpride were also systematically investigated. A total of 425 patients with schizophrenia were assessed, including Positive and Negative Syndrome Scales, Treatment Emergent Symptom Scale, blood routine examination, hepatorenal function, lipids, hormones, as well as myocardial enzymes at baseline, and following treatment with amisulpride for 8 weeks. The steady-state plasma concentration of amisulpride was assayed using two-dimensional liquid chromatography. At the same dose, the amisulpride plasma concentration of patients combined with clozapine was higher than that without clozapine. The therapeutic reference range of amisulpride can be defined as 230.3-527.1 ng/ml for Chinese patients with schizophrenia. The potential side effects appear to be associated with significantly increased levels of LDH, CK, creatine kinase isoenzyme (CK-MB), TC and decreased level of E 2 , relative to the amisulpride plasma concentration. These findings could provide individualized medication and reduce the adverse effects of amisulpride for Chinese patients with schizophrenia.

Case report: Amisulpride therapy induced reversible elevation of creatine kinase-MB and bradycardia in schizophrenia

“…A preclinical study showed that amisulpride induced cardiac lesions in rabbits, such as necrosis and deformation of the nuclei ( 8 ). Qu et al ( 9 ) indicated that amisulpride could affect cardiac functions, and the changed levels of LDH and CK were related to the plasma concentration of amisulpride. According to a recent meta-analysis, the common cardiac side effect of amisulpride is QTc prolongation ( 7 ).…”

On the benefits of therapeutic drug monitoring for patients undergoing treatment with antipsychotic agents

“…Sampling minute amounts of blood by fingerpricking is much less stressful and less expensive than traditional venepuncture, and in the future, it could be applied directly at home by patients or caregivers, further reducing stress, inconvenience and costs. Qu et al (2022) have fully acknowledged the potential benefits of extensive TDM application in psychiatry, also specifically observing that RR for the antipsychotic amisulpride is still uncertain. Moreover, they note (Qu et al, 2022) that amisulpride therapy personalisation is still hindered by the lack, or scarcity, of knowledge regarding personal (sex, age, comedication, etc.)…”

“…Qu et al (2022) have fully acknowledged the potential benefits of extensive TDM application in psychiatry, also specifically observing that RR for the antipsychotic amisulpride is still uncertain. Moreover, they note (Qu et al, 2022) that amisulpride therapy personalisation is still hindered by the lack, or scarcity, of knowledge regarding personal (sex, age, comedication, etc.) and lifestyle (smoking, alcohol consumption, etc.)…”

“…Qu et al . (2022) have fully acknowledged the potential benefits of extensive TDM application in psychiatry, also specifically observing that RR for the antipsychotic amisulpride is still uncertain.…”

Open issues in bipolar and antipsychotic treatments

“…Amisulpride is mainly used for schizophrenia, but it may be a possible option for the treatment of bipolar disorder (Carta et al , 2006). In the fourth paper in this issue, various aspects of therapeutic drug monitoring of amisulpride are reported (Qu et al , 2022). Results underline the importance of therapeutic drug monitoring in general and specifically for amisulpride given the relevant variability, drug interaction, and potential toxicity at higher plasma levels.…”