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||adult, aged, all-cause mortality, article, clinical trial, controlled clinical trial, controlled study, drug efficacy, drug exposure, drug safety, drug withdrawal, female, heart arrhythmia, hospitalization, human, major clinical, male, mortality, multicenter study, patient compliance, priority journal, randomized controlled trial, risperidone, safety, schizophrenia, sertindole, study, suicide attempt, treatment duration, treatment outcome|
|Persistent URL||dx.doi.org/10.1111/j.1600-0447.2010.01563.x, hdl.handle.net/1765/21242|
Thomas, S.H.L, Drici, M.D, Hall, G.C, Crocq, M.A, Everitt, B, Lader, M.H, … Mann, R.D. (2010). Safety of sertindole versus risperidone in schizophrenia: Principal results of the sertindole cohort prospective study (SCoP). Acta Psychiatrica Scandinavica, 122(5), 345–355. doi:10.1111/j.1600-0447.2010.01563.x