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.


METHODS
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).


CONCLUSIONS
Sertindole did not increase all-cause mortality, but cardiac mortality was higher and suicide attempts may be lower with sertindole.
Thomas
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SH
Institute of Cellular Medicine, Wolfson Unit of Clinical Pharmacology, Newcastle University, Newcastle, UK. simon.thomas@ncl.ac.uk
Drici
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Hall
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Crocq
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Everitt
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Lader
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Le Jeunne
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Naber
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Priori
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Sturkenboom
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Thibaut
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Peuskens
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Mittoux
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Tanghøj
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Toumi
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Moore
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D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D014150:Antipsychotic Agents / Q000009:adverse effects* / Q000627:therapeutic use; D001145:Arrhythmias, Cardiac / Q000139:chemically induced; D005260:Female; D006331:Heart Diseases / Q000139:chemically induced / Q000401:mortality; D006760:Hospitalization / Q000706:statistics & numerical data; D006801:Humans; D007093:Imidazoles / Q000009:adverse effects* / Q000627:therapeutic use; D007211:Indoles / Q000009:adverse effects* / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D016016:Proportional Hazards Models; D011446:Prospective Studies; D018967:Risperidone / Q000009:adverse effects* / Q000627:therapeutic use; D012559:Schizophrenia / Q000188:drug therapy* / Q000401:mortality; D013406:Suicide, Attempted / Q000706:statistics & numerical data; D055815:Young Adult
D014150:Antipsychotic Agents; D007093:Imidazoles; D007211:Indoles; C066304:sertindole; D018967:Risperidone