WEUKBRE7133: Drug Utilization Study (DUS) for REVOLADE™

Trial description: Chronic primary immune thrombocytopenia (ITP) is an acquired immune mediated disorder characterized by isolated thrombocytopenia, defined as a peripheral blood platelet count less than 100 x 10ˆ9/L, lasting for more than 12 months, and the absence of any underlying cause. In patients with chronic Hepatitis C virus (HCV), thrombocytopenia occurs most commonly in those with progressive liver disease and cirrhosis. In such patients, thrombocytopenia may render patients ineligible for antiviral treatment and require dose reductions or discontinuation and may also prevent patients from having liver biopsies and other invasive procedures, thereby hampering a physician’s ability to stage and monitor the patient’s liver condition. Eltrombopag (GlaxoSmithKline, Research Triangle Park, NC, USA) is an oral, non-peptide, thrombopoietin receptor (TPO-R) agonist that interacts with the TPO-R and induces differentiation of hematopoietic stem and progenitor cells to megakaryocytes, and has been approved for the treatment of adults with chronic ITP and chronic HCV associated thrombocytopenia. It is generally acknowledged that prescribing practices of any particular drug in real life clinical practice may differ from its use as defined in the authorized indications. This drug utilisation study (DUS) for eltrombopag will be conducted in several European countries to determine the indications for use and patient age ranges for which eltrombopag is currently being prescribed. This is a multi-national, multi-center study involving the retrospective review of approximately 300 to 450 patient medical records from selected European countries including France, Germany, Spain, Italy and Greece.REVOLADE is a trademark of the GSK group of companies.