GSK Reports PROMACTA(R) (eltrombopag) Significantly Increased Platelet Counts and Reduced Bleeding in Long-Term Study of Patients With C...(leeding.(1) Approximately 60000 individu...),Health

"Patients with chronic ITP often have a difficult time managing their disease. They may experience excessive bruising, bleeding and sometimes more serious hemorrhages that can rarely be fatal. Until recently, ITP patients have had few options well demonstrated to be effective in the long term," said James Bussel, M.D., director of the Platelet Disorders Center, Children's Cancer and Blood Foundation Division of New York Presbyterian/Weill Cornell Medical Center. "As the RAISE study demonstrates, PROMACTA is an important new oral treatment option for ITP patients that is effective in maintaining a hemostatic platelet response."

The RAISE Study (Abstract #400 Presented on December 8, 2008 at 11:45 a.m.)

RAISE, a global, six-month, double-blind, placebo-controlled, Phase III study was designed to evaluate the safety and efficacy of PROMACTA in previously treated adults with chronic ITP and with platelet counts less than 30,000/microliters. The study enrolled 197 patients (PROMACTA: n=135; placebo: n=62) and, of these, approximately 50 percent had platelet counts less than or equal to 15,000/microliters; about 50 percent were receiving simultaneous ITP therapies at randomization; around 35 percent were splenectomized, and more than 50 percent had received at least three prior ITP medications. Patients began once daily treatment with PROMACTA at 50 mg (or matching placebo) with doses individualized based upon each patient's platelet response, ranging from once-daily doses of 25 mg to 75 mg, or less frequently. The baseline median platelet count in both the placebo and the PROMACTA groups was 16,000/microliters.

Throughout the study, the median platelet count in the placebo group never exceeded 30,000/microliters. By contrast, after just one week, patients in the PROMACTA arm experienced a rise in their median plate
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