Cardiac effects of sertindole and quetiapine: Analysis of ECGs from a randomized double-blind study in patients with schizophrenia

Jimmi Nielsen, Jørgen Matz, Aurelia Mittoux, Christoffer Polcwiartek, Johannes J. Struijk, Egon Toft, Jørgen K. Kanters, Claus Graff

6 Citations (Scopus)

Abstract

The QT interval is the most widely used surrogate marker for predicting TdP; however, several alternative surrogate markers, such as Tpeak-Tend (TpTe) and a quantitative T-wave morphology combination score (MCS) have emerged. This study investigated the cardiac effects of sertindole and quetiapine using the QTc interval and newer surrogate markers. Data were derived from a 12 week randomized double-blind study comparing flexible dosage of sertindole 12-20. mg and quetiapine 400-600. mg in patients with schizophrenia. ECGs were recorded digitally at baseline and after 3, 6 and 12 weeks. Between group effects were compared by using a mixed effect model, whereas assessment within group was compared by using a paired t-test. Treatment with sertindole was associated with QTcF and QTcB interval prolongation and an increase in MCS, T-wave asymmetry, T-wave flatness and TpTe. The mean increase in QTcF from baseline to last observation was 12.1. ms for sertindole (p<0.001) and -0.5. ms for quetiapine (p=0.8). Quetiapine caused no increase in MCS, T-wave asymmetry, T-wave flatness or TpTe compared to baseline. In the categorical analysis, there were 11 patients (9.6%) receiving quetiapine who experienced more than 20. ms QTcF prolongation compared with 36 patients (33.3%) in the sertindole group. Sertindole (12-20. mg) was associated with moderate QTc prolongation and worsening of T-wave morphology in a study population of patients with schizophrenia. Although, quetiapine (400-600. mg) did not show worsening of repolarization measures some individual patients did experience significant worsening of repolarization. Clinical Trials NCT00654706.

Original languageEnglish
JournalEuropean Neuropsychopharmacology
Volume25
Issue number3
Pages (from-to)303-311
Number of pages9
ISSN0924-977X
DOIs
Publication statusPublished - 1 Mar 2015

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