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CNS Drugs

, Volume 18, Supplement 2, pp 19–30 | Cite as

A Review of the Efficacy, Tolerability and Safety of Sertindole in Clinical Trials

  • Lowijs Perquin
  • Tilman Steinert
Review Article

Abstract

Sertindole is a non-sedating atypical antipsychotic agent with high selectivity for dopaminergic neurons in the mesolimbic system. In pivotal clinical trials, sertindole has demonstrated significantly greater efficacy than placebo against both the positive and negative symptoms of schizophrenia. In addition, sertindole has had at least similar efficacy to haloperidol and risperidone against positive symptoms, and significantly greater efficacy than haloperidol and risperidone against negative symptoms. The incidence of extrapyramidal symptom (EPS)-related adverse events and the rate of medication used to treat EPS in patients receiving clinically effective doses of sertindole in clinical trials were similar to those observed in placebo recipients and significantly less than those in haloperidol recipients. The incidence of QTc interval prolongation of 500 ms or greater with therapeutic dosages of sertindole has also been low. In general, sertindole has been well tolerated in clinical trials. Unlike other antipsychotic agents, sertindole has not been associated with cognitive impairment, and can actually improve cognitive function. Observational studies have shown that the efficacy and tolerability of sertindole observed in the clinical trial situation are emulated in a naturalistic setting. Large cohort analyses (N > 8000) have shown that all-cause and cardiovascular mortality is no greater with sertindole than with risperidone or olanzapine.

Keywords

Haloperidol Risperidone Olanzapine Brief Psychiatric Rate Scale Sertindole 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

Notes

Acknowledgement

The data source for the manuscript was literature retrieval, the Serdolect product monograph, and manuscripts in preparation provided by H. Lundbeck A/S.

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Copyright information

© Adis Data Information BV 2004

Authors and Affiliations

  • Lowijs Perquin
    • 1
  • Tilman Steinert
    • 2
  1. 1.Psychiatric Center Amsterdam ValeriuskliniekAmsterdamthe Netherlands
  2. 2.Department of PsychiatryWeissenau Research UnitRavensburgGermany

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