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Sertindole: safety and tolerability profile.
International Journal of Psychiatry in Clinical Practice
|June 17, 2014
Summary
Sertindole, an atypical antipsychotic, shows a favorable safety profile with minimal extrapyramidal symptoms (EPS) compared to placebo and haloperidol. This well-tolerated drug offers a positive benefit/risk ratio for patients.
Area of Science:
- Pharmacology
- Neuroscience
- Psychiatry
Background:
- Sertindole is a novel atypical antipsychotic drug recently reintroduced.
- Its safety and tolerability have been evaluated in clinical trials and post-marketing studies.
Purpose of the Study:
- To assess the safety and tolerability profile of sertindole.
- To compare its side effect profile with placebo, haloperidol, risperidone, and olanzapine.
Main Methods:
- Clinical trials and post-marketing surveillance.
- Evaluation of extrapyramidal symptoms (EPS), sedation, anticholinergic effects, prolactin levels, QT interval, and mortality rates.
Main Results:
- Sertindole showed a similar incidence of EPS to placebo and significantly less than haloperidol.
- The drug demonstrated a lack of sedation, low anticholinergic activity, and no significant changes in prolactin levels.
- QT interval prolongation was observed in some patients, and mortality rates were comparable to risperidone and olanzapine.
Conclusions:
- Sertindole exhibits a positive benefit/risk ratio and is generally well-tolerated.
- Its selective dopamine D2 receptor blockade may contribute to the low incidence of EPS.
- The drug is a viable option for patients, with careful monitoring for QT prolongation.
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