A Review of the Efficacy, Tolerability and Safety of Sertindole in Clinical Trials
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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.
KeywordsHaloperidol Risperidone Olanzapine Brief Psychiatric Rate Scale Sertindole
The data source for the manuscript was literature retrieval, the Serdolect product monograph, and manuscripts in preparation provided by H. Lundbeck A/S.
- 11.Branford D, Thompson B, Muldoon C. Mortality in three comparative cohorts of patients who received sertindole, risperidone, and olanzapine: a hospital-based retrospective study. Poster presented at ICPE. Edinburgh, 18–21 August 2002Google Scholar
- 13.Azorin J-M, Toumi M, Sloth-Nielsen M. Sertindole is well tolerated and demonstrates efficacy advantages over risperidone in the treatment of moderate to severe schizophrenia. Poster presented at ECNP. Barcelona, 5–9 October 2002Google Scholar
- 15.Lis S, Krieger S, Gallhofer B, et al. Sertindole is superior to haloperidol in cognitive performance in patients with schizophrenia: a comparative study. Poster presented at ECNP. Prague, 20–24 September 2003Google Scholar
- 16.Steinert T, Hauger B, Eckhardt J, et al. Clinical observations of sertindole in 53 consecutive cases. Psycopharmakotherapie 2003; 10: 62–5Google Scholar
- 18.Lundbeck. data on fileGoogle Scholar
- 19.Serdolect1 (sertindole) monograph. Available at URL http://www.serdolect.com Accessed 13 November 2003
- 23.Toumi M, Anquier P, Francois C. The safety and tolerability of sertindole in a patient name use programme. Poster presented at ICPE. Edinburgh, 18–21 August 2002Google Scholar
- 24.Peuskens J, Moore N, Azorin J, et al. Sertindole European Safety and Exposure Survey: a retrospective study of 8,608 patients in Europe. Poster presented at ICPE. Edinburgh, 18–21 August 2002Google Scholar
- 25.Sturkenboom MCJM, Picelli G, Moore N. Mortality during use of sertindole and other anti-psychotics in the Netherlands and Belgium. Pharmacoepidemiol Drug Safety 2001; 10(Suppl. 1): S116Google Scholar
- 26.Kasper S, Quiner S, Pezawas L. A review of the benefit:risk profile of sertindole. Int J Psychiatry Clin Pract 1998; 2(Suppl. 2): S59–S64Google Scholar