Effect of sertindole on QTc interval in patients with schizophrenia.

Abstract:

:Sertindole has been marketed and offered daily clinical practice only for 9 months in our country, so no data has been its QTc prolongation potential. In the present study, we performed a clinical trial to investigate the effects of sertindole on QTc in patients with schizophrenia. The study comprised 21 patients with schizophrenia. Sertindole was administered in the following dosing regime: treatment was initiated with 4 mg/day sertindole. From day 3 to day 6, the dose was increased to 8 mg/day, and up to day 9, it was raised to 12 mg/day. The protocol allowed up to dose of 20mg/day according to effectiveness and tolerability. QTc values were determined at beginning, months 3 and 6. In addition, Positive and Negative Syndrome Scale (PANSS) were scored concomitantly. At the beginning of 6-month period, the mean QTc interval of patients was 391.7+/-19.2 ms. At the end of this period, it was 402.8+/-23.8 ms. Although the mean QTc interval changing was significant throughout 6-month period, of the patients, at any evaluation point, only 1 female (451 ms) and 1 male (433 ms) had borderline prolongation at month 3 for both, without any exceeding the dangerous limits. In summary, our results suggest that sertindole is tolerable and despite dose-related QT prolongation, sertindole had not the proarrhythmic profile. Future studies with larger sample evaluating the effects of treatment are required.

journal_name

Neurosci Lett

journal_title

Neuroscience letters

authors

Atmaca M,Yavuzkir M,Mermi O,Topuz M,Kanmaz E,Tezcan E

doi

10.1016/j.neulet.2008.05.065

subject

Has Abstract

pub_date

2008-09-05 00:00:00

pages

1-3

issue

1

eissn

0304-3940

issn

1872-7972

pii

S0304-3940(08)00728-3

journal_volume

442

pub_type

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