The European Post-marketing Observational Serdolect® (EPOS) project

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Abstract
Well-controlled clinical trials, although essential for registration purposes, often fail to reflect the real-life usage of a drug. Ultimately, it is how a new medicinal product is used in clinical practice, how it performs in everyday life and how the patient who takes it feels and functions that determine the real benefit: risk ratio of the drug. Such a prospective, referenced, cohort study of sertindole (Serdolect®, H. Lundbeck A/S, Copenhagen, Denmark) in schizophrenia was initiated in 1997. Sertindole is a new limbic-selective antipsychotic agent which has recently received marketing authorization in several countries across Europe for the treatment of schizophrenia. The experience gained in around 2200 sertindole-treated patients in controlled clinical trials has enabled an optimal targeting of sertindole to those patient groups who will benefit most and who are least likely to experience adverse effects. The European Post-marketing observational Serdolect® (EPOS) project plans to recruit over 12 000 patients in two cohorts in centres throughout Europe, The aims are to provide a full safety evaluation of sertindole under marketed conditions at the relevant clinical dosage and, further, to provide epidemiological data on the treatment of schizophrenia in Europe under usual clinical conditions. The study is currently the only one of its kind to be undertaken in schizophrenia, and will provide important new data for psychia-trists around the world.

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