Why the study?
Does sertindole increase the risk of QT interval prolongation and lethal complications in treated patients?
Does sertindole increase the risk of QT interval prolongation and lethal complications in treated patients?
While sertindole can cause QT interval prolongation in a small proportion of patients, it does not appear to increase the risk of lethal complications, though ECG monitoring is recommended.
Sertindole is a limbic-selective antipsychotic agent with a strong affinity for D2, 5-HT2 and α1-adrenergic receptors. Prolongation of the QT interval and other adverse cardiac or cardiovascular reactions are known effects of most antipsychotic drugs. For this reason such effects have been extensively monitored during clinical trials of sertindole. A small proportion of sertindole-treated patients were found to exhibit an increase in QT interval. Detailed analysis revealed no increased risk with sertindole of lethal complications due to an increase in QT interval. Nevertheless, as with other antipsychotics, electrocardiogram (ECG) recordings should be made prior to starting and during treatment with sertindole.
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Fritze et al. (1998) studied this question.
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