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PROWESS
About the Trial
PROWESS randomized 1,690 patients with severe sepsis to drotrecogin alfa activated, a recombinant form of activated protein C, or placebo. Twenty-eight day mortality fell from 30.8 to 24.7 percent, and the drug, marketed as Xigris, became the first approved therapy specifically for sepsis in 2001, despite a divided FDA advisory committee and concerns about bleeding. Subsequent trials failed to show benefit in lower risk patients and children, and in 2011 the PROWESS-SHOCK trial found no mortality reduction in septic shock, prompting worldwide withdrawal. The story became a cautionary lesson about approving drugs on a single pivotal trial in a heterogeneous syndrome.
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