Effect of sertindole on QTc interval in patients with schizophrenia.
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.
Atmaca
Murad
M
Department of Psychiatry, Firat University, School of Medicine, Elazig, Turkey. matmaca_p@yahoo.com
Yavuzkir
Mustafa
M
Mermi
Osman
O
Topuz
Mehtap
M
Kanmaz
Ebru
E
Tezcan
Ertan
E
D000328:Adult; D014150:Antipsychotic Agents / Q000009:adverse effects*; D004562:Electrocardiography / Q000187:drug effects; D005260:Female; D006339:Heart Rate / Q000187:drug effects*; D006801:Humans; D007093:Imidazoles / Q000009:adverse effects*; D007211:Indoles / Q000009:adverse effects*; D008297:Male; D012559:Schizophrenia / Q000188:drug therapy*
D014150:Antipsychotic Agents; D007093:Imidazoles; D007211:Indoles; C066304:sertindole