Key result
In patients with schizophrenia taking amisulpride, comedication with clozapine (OR 3.5; 95% CI 1.3-9.7) and decreased renal function were independent risk factors for QTc prolongation.
Why the study?
Amisulpride is widely prescribed for schizophrenia but can cause prolonged QTc interval, prompting an assessment of risk factors for QTc prolongation during therapy.
What are the risk factors for QTc prolongation during amisulpride therapy in patients with schizophrenia?
Observational (n=271)
What are the risk factors for QTc prolongation during amisulpride therapy in patients with schizophrenia?
In patients with schizophrenia taking amisulpride, comedication with clozapine and decreased renal function significantly increase the risk of QTc prolongation.
QTc monitoring may be prudent with amisulpride plus clozapine or reduced renal function; leaves open whether associations are causal.
BACKGROUND: Amisulpride (AMI) is a popular antipsychotic drug prescribed for the management of schizophrenia. However, patients may experience prolonged corrected QT (QTc) interval. We therefore aimed to assess the risk factors for QTc prolongation during AMI therapy in patients with schizophrenia. METHODS: This study retrospectively enrolled 271 patients with schizophrenia. Continuous variables were analyzed with a t test or analysis of variance, and categorical variables were analyzed with a χ test. Patients with and without QTc prolongation were compared using a backward stepwise logistic regression analysis to identify the important variables. RESULTS: Comedication of AMI with clozapine (odds ratio, 3.5 [95% confidence interval, 1.3-9.7]) and decreased renal function (mildly decrease, 3.4 [1.2-10.1]; mild to moderately decreased, 4.8 [1.3-17.3]; moderately decreased, 13.6 [2.0-90.6]) were identified as the independent risk factors of QTc prolongation. The dose-normalized plasma concentration of AMI (plasma concentration per dose) was significantly higher in the QTc prolongation group (z = -1.735, P = 0.015) and renal dysfunction group (F = 16.002, P < 0.001). CONCLUSIONS: Renal function should be monitored in patients prescribed with AMI, particularly in those taking clozapine. Plasma concentration per dose values can be considered as a risk factor of QTc interval prolongation. The founding help clinicians to analyze the risk of QTc prolongation before prescribing AMI and to monitor QTc prolongation during AMI therapy.
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Chen et al. (2020) conducted an observational in Schizophrenia (n=271). Clozapine comedication and decreased renal function vs. No clozapine comedication and normal renal function was evaluated on QTc prolongation (OR 3.5, 95% CI 1.3-9.7). In patients with schizophrenia taking amisulpride, comedication with clozapine (OR 3.5; 95% CI 1.3-9.7) and decreased renal function were independent risk factors for QTc prolongation.
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