Safety of sertindole versus risperidone in schizophrenia: principal results of the sertindole cohort prospective study (SCoP)
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.
Document Type: Research Article
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: 2010-11-01