Sertindole: dilemmas for its use in clinical practice
1The Catholic University of Korea College of Medicine, Department of Psychiatry, Bucheon St Mary's Hospital, Sosa-Dong, Wonmi-Gu, Bucheon, Kyeonggi-Do 420-717, Republic of Korea. pae@catholic.ac.kr
Expert Opinion on Drug Safety
|February 26, 2013
Summary
Sertindole, an antipsychotic, was withdrawn and relaunched due to cardiac concerns. While effective, its use requires careful benefit-risk evaluation, especially regarding QT interval prolongation and dysrhythmias.
Area of Science:
- Psychiatry and Pharmacology
- Cardiovascular Safety in Antipsychotic Use
Background:
- Sertindole was withdrawn in 1998 due to cardiac safety concerns (QT prolongation, dysrhythmia).
- Following extensive safety reviews, sertindole was reintroduced in Europe in 2005.
Purpose of the Study:
- To evaluate the efficacy and safety of sertindole as an antipsychotic medication.
- To address ongoing concerns regarding cardiac adverse events associated with sertindole use.
Main Methods:
- Review of seven randomized, double-blind clinical trials on sertindole's efficacy and tolerability.
- Analysis of long-term effectiveness and tolerability in a 52-week clinical trial.
- Contemporary database search and cross-reference checks for cardiac adverse events.
Main Results:
- Sertindole demonstrates superior efficacy to haloperidol and comparable efficacy to risperidone.
- Clinical trials indicate placebo-level sedation and extrapyramidal symptoms with sertindole.
- The United States Food and Drug Administration (FDA) has not yet approved claims regarding suicide risk reduction or general safety.
Conclusions:
- Despite European reapproval, concerns persist regarding sertindole's association with QT prolongation and dysrhythmias.
- A clinical practice consensus on sertindole use has not been established.
- Conservative use is recommended only after antipsychotic medication failure, with thorough benefit-risk assessment.
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