title: EPOS: Increasing our understanding of the treatment of schizophrenia; Start of a prospective referenced cohort study of sertindole in clinical practice.
abstract: 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 patients treated with sertindole in controlled clinical trials has enabled optimal targeting of sertindole to those patient groups who will benefit most and who are least likely to experience adverse effects. 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 a new medicinal product. The European Post-marketing Observational Serdolect® project (EPOS) is a post-marketing, referenced, observational, cohort, safety study in the treatment of schizophrenic patients initiated earlier this year. It is planned 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 schizophrenic patients receiving sertindole or other treatment under the usual clinical conditions in Europe. At the moment, the study is the only one of its kind to be undertaken in schizophrenia and will provide important new data for psychiatrists around the world.
authors.affiliation: H. Lundbeck A/S, Copenhagen, Denmark.
authors.forename: A
authors.initials: A
authors.lastname: Wehnert
authors.forename: A
authors.initials: A
authors.lastname: Hale
authors.forename: S
authors.initials: S
authors.lastname: Kasper
authors.forename: H J
authors.initials: HJ
authors.lastname: Moller
authors.forename: R
authors.initials: R
authors.lastname: Campbell
authors.forename: C
authors.initials: C
authors.lastname: Stilwell
authors.forename: M
authors.initials: M
authors.lastname: Sloth-Nielsen
keywords: adverse events; epidemiology; observational study; schizophrenia; sertindole