Pharmacoepidemiology and Drug Safety vol:17 issue:5 pages:425-433
PURPOSE: To describe the rationale and methodology of the Sertindole Cohort Prospective (SCoP) study. METHODS: The SCoP study was a prospective, randomized, partially blinded, active-controlled, multinational trial. It was designed to assess the safety of the antipsychotic sertindole in the treatment of schizophrenia under normal conditions of use. Risperidone, a widely used antipsychotic, not associated with major safety concerns, served as comparator drug. Inclusion criteria were deliberately broad in order to ensure high external validity, but patients had to be eligible for treatment with both drugs. The first primary endpoint was all-cause mortality, a measure highly resistant to bias, and the second was hospitalization with arrhythmia. Secondary endpoints comprised cause-specific fatal events, hospitalizations, suicide attempts and treatment duration. An Independent Safety Committee (ISC) classified the events using blinded data and provided advice to an Independent Management Committee (IMC) that was overseeing the trial. It was calculated that 3800 person years of exposure were needed in each treatment arm to obtain a power of 80%. This makes the SCoP study one of the largest post-authorization trials ever conducted in schizophrenia research. RESULTS: This report describes the design of the study, its rationale and the methods used. CONCLUSIONS: Naturalistic estimates of drug safety constitute essential information when prescribing antipsychotic medication. In the SCoP study, data were collected prospectively in a randomized, controlled manner and under normal conditions of use. Such a design ensured the high quality of data needed to adequately evaluate the 'real-world' safety of sertindole treatment.