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

0 years of age, to 47.8% for those older than 60 years.(3)

"We are extremely encouraged by these PROMACTA results, and what this may mean for ITP patients," said Paolo Paoletti, M.D., Senior Vice President, Oncology Medicine Development Center, GSK. "This pivotal Phase III trial data and our ongoing efforts to assess the benefits of both short- and long-term treatment of PROMACTA will be part of GSK's commitment to work with regulatory authorities and ensure new treatment options for ITP patients are provided."

The Phase III trial was an international, randomized, double-blind, placebo-controlled study that enrolled 114 adults with chronic ITP and baseline platelet counts of <30,000/microliter. Eligible patients must have failed or stopped responding within three months of receiving one or more ITP therapies such as corticosteroids, immunoglobulins and/or splenectomy. Patients were allowed to continue on a concomitant ITP medication, provided their dose had been stable for at least a month prior to enrollment. These patients were randomized to either placebo (38 patients) or PROMACTA 50mg (76 patients) once daily for six weeks. The PROMACTA dose could be increased to 75mg in patients not responding after an initial three weeks of treatment. Patients were assessed for platelet count weekly and up to six weeks following treatment with PROMACTA. Bleeding events were assessed weekly using the World Health Organization (WHO) bleeding scale.(1)

At the end of the trial, 59% of PROMACTA treated patients and 16% of placebo treated patients achieved a platelet count of more than 50,000/microliter. Importantly, there was a significantly lower incidence of bleeding events during treatment with PROMACTA compared to placebo (p=0.029) with clinically significant bleeding (WHO Grades 2-4) observed in fewer PROMACTA patients (16%) than placebo patients (36%). The most common adverse event (AE) observed in this study was headache, reported in 8% and 11% of patien
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