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Pivotal Phase III Trial Showed Promacta (eltrombopag olamine),Raised Platelet Counts and Reduced Bleeding in Patients With,Chronic ITP

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ITP is characterized by increased autoimmune platelet destruction and/or inadequate platelet production. Its cause is currently unknown. Some patients with ITP are asymptomatic or have mild bruising while others develop more serious bleeding that can be life-threatening.(6) A normal blood platelet count is greater than or equal to 150,000/microliter and less than or equal to 400,000/microliter.(7) A reduction in platelet count (to a level <150,000/microliter) is the defining characteristic of any type of thrombocytopenia which can be confirmed following a routine blood test. An endpoint of 50,000/microliter was selected because at a platelet count of <50,000/microliter there is a higher risk of developing bleeding complications from low platelet counts. At a platelet count of >50,000/microliter there is a lower risk of bleeding and bruising. This is consistent with products previously approved to treat ITP and is considered as a target platelet count in ITP treatment guidelines.(8)

Other Forms of Thrombocytopenia

Thrombocytopenia can occur as a consequence of an autoimmune abnormality, bone marrow insufficiency, chemotherapy treatment, interferon treatment, viral infection or chronic liver disease.(9,10) Thrombocytopenia can impede a variety of diagnostic and/or medical treatments. It can prevent cancer patients from receiving their full dose of chemotherapy on schedule, preclude patients with hepatitis C infection from receiving interferon therapy or lead to dose reductions or discontinuation of therapy, and complicate surgical or dental procedures.(11,12)

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