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| |  Eltrombopag Demonstrates Safety and Efficacy in Idiopathic Thrombocytopenic Purpura: Presented at EHA By Emma Hitt, PhD COPENHAGEN, Denmark -- June 13, 2008 -- Eltrombopag appears to be safe and effective in patients with idiopathic thrombocytopenic purpura (ITP), according to a pooled analysis of efficacy and safety data. James B. Bussel, MD, Weill Medical College, Cornell University, New York, New York, and colleagues presented the findings here on June 13 at the 13th Congress of the European Hematology Association. Eltrombopag is a first-in-class, oral, small-molecule thrombopoietin receptor agonist. Two randomised trials -- a phase 2 and a phase 3 -- have been conducted to date. The pooled analysis served to further clarify the efficacy and safety of eltrombopag. In addition, the most recent results from the phase 3 Eltrombopag Extended Dosing Study (EXTEND) were reported at the meeting. The trial is an ongoing open-label extension study evaluating the long-term safety and efficacy of eltrombopag. A total of 109 patients with chronic ITP previously treated with eltrombopag received an initial dose of 50 mg daily. The dose was then adjusted according to platelet levels, with daily doses ranging between 25 and 75 mg, or less often if needed. The median duration of treatment was 194 days. After starting eltrombopag treatment, 80% of patients achieved platelet counts >50,000 cells/mcL at least once, and of those, 78% maintained platelet levels >50,000 cells/mcL for at least half of the study duration. Adverse events were mostly mild to moderate. The most common adverse event was headache (17%). Four patients experienced 4 thromboembolic events (2 pulmonary embolism, 1 transient ischaemic attack, 1 deep vein thrombosis), all with pre-existing thromboembolic risk factors. The pooled analysis of data also included 67 patients receiving placebo and 106 patients receiving eltrombopag. At least 60% of patients had an increase in platelets to at least 50,000 cells/mcL, and bleeding incidence was reduced in patients receiving eltrombopag compared with placebo. Nasopharyngitis (7% vs 4%) and nausea (6% vs 4%) were the only adverse events to occur in at least 5% of patients and were more frequent with eltrombopag than placebo. No evidence of increased risk of thromboembolic events or cataract was observed in patients receiving eltrombopag. "It's possible that over an extended period of treatment, adverse events could develop or become significant. But thus far, this agent has been remarkably side-effect free and easy to tolerate," Dr. Bussel said. One particularly exciting application is in patients with hepatitis C, Dr. Bussel said. "This agent can help patients stay on interferon/ribavirin treatment who would otherwise have to stop treatment." He added that eltrombopag appears to maintain stable platelet counts over months rather than weeks.
[Presentation titles: Long-Term Safety and Efficacy of Oral Eltrombopag for the Treatment of Idiopathic Thrombocytopenic Purpura (ITP). Abstract 949]
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