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 journalArticle

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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

Fingerprint

Risperidone
Schizophrenia
Cohort Studies
Prospective Studies
Safety
Mortality
Suicide
Hospitalization
Research Personnel
Attempted Suicide
sertindole
Cardiac Arrhythmias

Keywords

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

ASJC Scopus subject areas

  • Psychiatry and Mental health

Cite this

Safety of sertindole versus risperidone in schizophrenia : Principal results of the sertindole cohort prospective study (SCoP). / Thomas, S. H L; Drici, M. D.; Hall, G. C.; Crocq, M. A.; Everitt, B.; Lader, M. H.; Jeunne, C. Le; Naber, D.; Priori, S.; Sturkenboom, M.; Thibaut, F.; Peuskens, J.; Mittoux, A.; Tanghøj, P.; Toumi, M.; Moore, N. D.; Mann, R. D.

In: Acta Psychiatrica Scandinavica, Vol. 122, No. 5, 11.2010, p. 345-355.

Research output: Contribution to journalArticle

Thomas, SHL, Drici, MD, Hall, GC, Crocq, MA, Everitt, B, Lader, MH, Jeunne, CL, Naber, D, Priori, S, Sturkenboom, M, Thibaut, F, Peuskens, J, Mittoux, A, Tanghøj, P, Toumi, M, Moore, ND & Mann, RD 2010, 'Safety of sertindole versus risperidone in schizophrenia: Principal results of the sertindole cohort prospective study (SCoP)', Acta Psychiatrica Scandinavica, vol. 122, no. 5, pp. 345-355. https://doi.org/10.1111/j.1600-0447.2010.01563.x
Thomas, S. H L ; Drici, M. D. ; Hall, G. C. ; Crocq, M. A. ; Everitt, B. ; Lader, M. H. ; Jeunne, C. Le ; Naber, D. ; Priori, S. ; Sturkenboom, M. ; Thibaut, F. ; Peuskens, J. ; Mittoux, A. ; Tanghøj, P. ; Toumi, M. ; Moore, N. D. ; Mann, R. D. / Safety of sertindole versus risperidone in schizophrenia : Principal results of the sertindole cohort prospective study (SCoP). In: Acta Psychiatrica Scandinavica. 2010 ; Vol. 122, No. 5. pp. 345-355.
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