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Novel Therapeutic Approaches May Transform Treatment and Improve Patient Outcomes in Several Platelet Disorders
Date:12/6/2008

ansfusions were the same in both arms.

Oral Eltrombopag for the Long-Term Treatment of Patients With Chronic Idiopathic Thrombocytopenic Purpura (ITP): Results of a Phase III, Double-Blind, Placebo-Controlled Study

[Abstract #400]

Gregory Cheng, ChineseUniversityof Hong Kong,Hong Kong,China

This double-blind, multicenter, phase III study found that long-term eltrombopag therapy compared with placebo treatment significantly increased platelet counts, decreased bleeding symptoms, allowed for a reduction of baseline ITP therapy, and reduced the use of rescue medications in previously treated patients with chronic ITP. In chronic ITP, low blood platelet counts persist unless treated and can last for an indefinite amount of time.

A total of 197 patients with platelet counts less than 30,000 microliters were stratified by splenectomy status, use of baseline ITP medication, and platelets of less than or equal to 15,000 microliters. They were randomized to receive either eltrombopag at a starting dose of 50 mg once daily (135 patients) or placebo once daily (62 patients). Depending on individual platelet response, the dose of eltrombopag could be titrated within a range from 25 mg once daily to a maximum dose of 75 mg once daily.

The primary endpoint of the study was the odds of achieving platelet counts between 50,000 and 400,000 microliters in patients receiving eltrombopag as compared with placebo. To measure the drug's safety, bleeding symptoms were prospectively evaluated using the WHO Bleeding Scale.

Patients who received eltrombopag were eight times more likely to achieve platelet counts of 50,000 to 400,000 microliters during the six-month treatment period as compared with those in the placebo arm. While baseline median platelet counts were 16,000 microliters in both
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SOURCE American Society of Hematology
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