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

• Published in: Acta psychiatrica Scandinavica Vol. 122; no. 5; pp. 345 - 355
• Main Authors: 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.
• Format: Journal Article
• Language: English
• Published: Oxford, UK Blackwell Publishing Ltd 01-11-2010; Blackwell
• Subjects: Adolescent; Adult; Adult and adolescent clinical studies; Aged; Aged, 80 and over; all-cause mortality; Antipsychotic Agents - adverse effects; Antipsychotic Agents - therapeutic use; Arrhythmias, Cardiac - chemically induced; Biological and medical sciences; Clinical trials; Drug therapy; Female; Heart Diseases - chemically induced; Heart Diseases - mortality; Hospitalization - statistics & numerical data; Humans; Imidazoles - adverse effects; Imidazoles - therapeutic use; Indoles - adverse effects; Indoles - therapeutic use; Male; Medical sciences; Middle Aged; Neuropharmacology; Pharmacology. Drug treatments; Proportional Hazards Models; Prospective Studies; Psycholeptics: tranquillizer, neuroleptic; Psychology. Psychoanalysis. Psychiatry; Psychopathology. Psychiatry; Psychopharmacology; Psychoses; risperidone; Risperidone - adverse effects; Risperidone - therapeutic use; Safety; Schizophrenia; Schizophrenia - drug therapy; Schizophrenia - mortality; sertindole; Suicide, Attempted - statistics & numerical data; Young Adult; Atypical antipsychotic; Neuroleptic; Psychotropic; Dopamine antagonist; Serotonin antagonist; Mortality; Schizophrenia; Serotonine receptor; Sertindole; Psychosis; D2 Dopamine receptor; Follow up study; Cohort study; all-cause mortality; Safety; Risperidone; Benzisoxazole derivatives; Comparative study
• ISSN: 0001-690X; 1600-0447
• DOI: 10.1111/j.1600-0447.2010.01563.x

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.