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Comparison of the Safety Profile of Sickle Cell Disease Patients Treated with Hydroxycarbamide in Off-Label Versus in-Label Prescriptions in the Escort-HU Non Interventional, Prospective, Observational Open-Label Cohort Study

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source: American Society of Hematology

year: 2016

authors: Ersi Voskaridou, Stephan Lobitz, Uwe Kordes, Regine Grosse, Valentine Brousse, Malika Benkerrou, Mariane De Montalembert, Jean-Antoine Ribeil, Frederic Galacteros

summary/abstract:

ESCORT-HU (European Sickle Cell Disease (SCD) COhoRT – HydroxyUrea) is a multicenter prospective non interventional study implemented in Europe, following the European Medical Agency’s request to collect more information focused on long-term safety profile of hydroxycarbamide (HU) in SCD patients treated with HU. Primary endpoint of the study is to determine the frequency of adverse events (AEs) under HU treatment Secondary endpoints include the efficacy of HU in labeled indications (prevention of vaso-occlusive complications and of acute thoracic syndrome), frequency of hospitalizations due to SCD events and frequency of blood transfusions. Data collection on the reason for HU initiation permitted to identify in-label (in the therapeutic indication of the European marketing authorization, group 1, G1) and off-label (other therapeutic indication, group 2, G2) prescriptions of HU. Frequency of AEs (including not related to SCD and infections) was compared between adults and children, both in G1 and G2, with focus on the following subclasses: blood and lymphatic system disorders, fever, gastrointestinal disorders, infection, nervous system disorders, skin and subcutaneous tissue disorders and others.

organization: Laiko General Hospital, Athens; Charité-Universitätsmedizin, Berlin; Universitätsklinikum Hamburg-Eppendorf; University Medical Center Hamburg-Eppendorf; Hôpital Universitaire Necker-Enfants Malades, Paris; Laboratory of Excellence, GR-ex, Paris; Hopital Robert Debré, APHP, Paris; Centre de la Drépanocytose, Hôpital Henri Mondor, Creteil

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