Safety of sertindole versus risperidone in schizophrenia: Principal results of the sertindole cohort prospective study (SCoP)

S. H L Thomas, M. D. Drici, G. C. Hall, M. A. Crocq, B. Everitt, M. H. Lader, C. Le Jeunne, D. Naber, S. Priori, M. Sturkenboom, F. Thibaut, J. Peuskens, A. Mittoux, P. Tanghøj, M. Toumi, N. D. Moore, R. D. Mann

Research output: Contribution to journalArticlepeer-review

Abstract

Objective: To explore whether sertindole increases all-cause mortality or cardiac events requiring hospitalization, compared with risperidone. Method: Multinational randomized, open-label, parallel-group study, with blinded classification of outcomes, in 9858 patients with schizophrenia. Results: After 14147 person-years, there was no effect of treatment on overall mortality (sertindole 64, risperidone 61 deaths, Hazard Ratio (HR) = 1.12 (90% CI: 0.83, 1.50)) or cardiac events requiring hospitalization [sertindole 10, risperidone 6, HR = 1.73 (95% CI: 0.63, 4.78)]: Of these, four were considered arrhythmia-related (three sertindole, one risperidone). Cardiac mortality was higher with sertindole (Independent Safety Committee (ISC): 31 vs. 12, HR=2.84 (95% CI: 1.45, 5.55), P = 0.0022; Investigators 17 vs. 8, HR=2.13 (95% CI: 0.91, 4.98), P = 0.081). There was no significant difference in completed suicide, but fewer sertindole recipients attempted suicide (ISC: 68 vs. 78, HR=0.93 (95% CI: 0.66, 1.29), P = 0.65; Investigators: 43 vs. 65, HR=0.67 (95% CI: 0.45, 0.99), P = 0.044). Conclusion: Sertindole did not increase all-cause mortality, but cardiac mortality was higher and suicide attempts may be lower with sertindole.

Original languageEnglish
Pages (from-to)345-355
Number of pages11
JournalActa Psychiatrica Scandinavica
Volume122
Issue number5
DOIs
Publication statusPublished - Nov 2010

Keywords

  • all-cause mortality
  • risperidone
  • safety
  • schizophrenia
  • sertindole

ASJC Scopus subject areas

  • Psychiatry and Mental health

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