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

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Abstract:

Thomas SHL, Drici MD, Hall GC, Crocq MA, Everitt B, Lader MH, Le Jeunne C, Naber D, Priori S, Sturkenboom M, Thibaut F, Peuskens J, Mittoux A, Tanghøj P, Toumi M, Moore ND, Mann RD. Safety of sertindole versus risperidone in schizophrenia: principal results of the sertindole cohort prospective study (SCoP) 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.

Keywords: all-cause mortality; risperidone; safety; schizophrenia; sertindole

Document Type: Research Article

DOI: http://dx.doi.org/10.1111/j.1600-0447.2010.01563.x

Affiliations: 1: Institute of Cellular Medicine, Wolfson Unit of Clinical Pharmacology, Newcastle University, Newcastle, UK 2: Pharmacologie-Toxicologie, Hôpital Pasteur, Nice Cedex 1, France 3: Grimsdyke House, Herts, UK 4: Centre Hospitalier, Rouffach and CAMUHA, University of Upper Alsace, Mulhouse, France 5: Institute of Psychiatry, King’s College London, Denmark Hill, London, UK 6: Groupe Hospitalier Hotel-Dieu – La Collegiale, Paris, France 7: Universitaetsklinikum Hamburg-Eppendorf, Klinik fuer Psychiatrie und 0therapie, Hamburg, Germany 8: Molecular Cardiology, University of Pavia, Pavia, Italy 9: Department Medical Informatics and Epidemiology, Erasmus University Medical Center, Rotterdam, the Netherlands 10: University Hospital Ch Nicolle, INSERM U 614, Faculty of Medicine, Rouen, France 11: University Psychiatric Center K.U. Leuven, Belgium 12: H. Lundbeck A/S, Valby, Copenhagen, Denmark 13: Université Claude Bernard Lyon, Bat Nautibus, Villeurbane Cedex, France 14: Département de Pharmacologie CHU de Bordeaux-Pellegrin, France 15: Professor Emeritus, University of Southampton, Waterlooville, Hampshire, UK

Publication date: November 1, 2010

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