The European post-marketing observational sertindole study: an investigation of the safety of antipsychotic drug treatment.
The objective of the European Post-marketing Observational Serdolect((R)) (EPOS) Study was to compare the safety of treatment with Serdolect (sertindole) with that of usual treatment in patients with schizophrenia, in normal European clinical practice. The EPOS was a multicentre, multinational, referenced, cohort study. Patients were enrolled at 226 centres in ten European countries. The study was prematurely terminated in 1998 as a result of the temporary market suspension of sertindole. Termination of the study reduced the number of patients recruited from the planned 12,000 to 2,321. While the power of the study was weakened, it did provide useful mortality information, which may be useful for future long-term studies. Crude mortality in the sertindole and non-sertindole groups was 1.45 (95% confidence interval, CI 0.53-3.16) and 1.50 (CI 0.72-2.76) deaths/100 patient-years exposed, respectively. There were no more cardiac deaths in the sertindole group than in the non-sertindole group. QT interval prolongation did not translate into an increased risk of death. Sertindole was well tolerated and caused few extrapyramidal symptoms. Although CIs remained large, this post-marketing study does not provide any evidence against the use of sertindole under normal conditions. Sertindole was well tolerated and posed no significant safety problems.
Kasper
Siegfried
S
Department of Psychiatry and Psychotherapy, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria. sci-biolpsy@meduniwien.ac.at
Möller
Hans-Jürgen
HJ
Hale
Anthony
A
D000293:Adolescent; D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems; D014150:Antipsychotic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D004562:Electrocardiography; D005060:Europe / Q000453:epidemiology; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007093:Imidazoles / Q000009:adverse effects / Q000627:therapeutic use*; D007211:Indoles / Q000009:adverse effects / Q000627:therapeutic use*; D008133:Long QT Syndrome / Q000139:chemically induced; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance; D011358:Product Surveillance, Postmarketing / Q000379:methods*; D011569:Psychiatric Status Rating Scales; D012449:Safety; D012559:Schizophrenia / Q000188:drug therapy* / Q000401:mortality; D012720:Severity of Illness Index; D016896:Treatment Outcome; D055815:Young Adult
D014150:Antipsychotic Agents; D007093:Imidazoles; D007211:Indoles; C066304:sertindole