GSK Reports PROMACTA(R) (eltrombopag) Significantly Increased Platelet Counts and Reduced Bleeding in Long-Term Study of Patients With C...(let count to36000/microliters with media...),Health

Date:12/6/2008

let count to 36,000/microliters, with median platelet levels subsequently ranging from 52,000 to 91,000/microliters for the remainder of the study, meeting the study's primary endpoint of odds of responding (platelets 50,000 to 400,000/microliters) during the six month treatment period. Patients receiving PROMACTA were eight times more likely to achieve an overall response of increased platelet counts of 50,000 to 400,000/microliters than those taking placebo (Odds ratio = 8.2; 99 percent CI [3.59, 18.73]; p < 0.001). In comparison to the placebo group, significantly fewer patients treated with PROMACTA had any bleeding or clinically significant (WHO Grades 2-4; p < 0.001) bleeding throughout the trial and more patients in the PROMACTA group (59 percent) stopped or reduced their simultaneous ITP medications than in the placebo group (32 percent; p = 0.016). In addition, during the treatment phase of the study, fewer patients in the PROMACTA arm (19 percent) required rescue therapy compared with those in the placebo arm (40 percent, p = 0.001).

The overall incidence of adverse events was similar between the PROMACTA (87 percent) and placebo groups (92 percent), which were mostly mild to moderate in severity. Headache was the most common adverse event in both groups (greater than or equal to 30 percent). Two corticosteroid-associated adverse events (dyspepsia and peripheral edema) were significantly less likely to occur in the PROMACTA group compared to the placebo group; however, a higher incidence of hepatobiliary laboratory abnormalities were reported in patients taking PROMACTA (13 percent) compared with those in the placebo group (7 percent). These abnormalities were not predictive of serious, drug-induced liver injury. One death was reported in the placebo group. There were no clinical or laboratory symptoms suggestive of bone marrow fibrosis in patients taking PROMACTA.

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