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

2010; Wiley; Volume: 122; Issue: 5 Linguagem: Inglês

10.1111/j.1600-0447.2010.01563.x

1600-0447

Simon H. L. Thomas, Milou D. Drici, Gillian C. Hall, M.A. Crocq, Barry J. Everitt, M Lader, Claire Le Jeunne, Dieter Naber, S Priori, Miriam Sturkenboom, Florence Thibaut, J. Peuskens, Aurélia Mittoux, P. Tanghøj, Mondher Toumi, Nicholas Moore, Ronald D. Mann,

Bipolar Disorder and Treatment

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.