• Jon Henrik Laake, Jon Bragi Bergmann, Fridtjov Riddervold, Arvid Bjørneklett, Pål Aukrust, and Stig S Frøland.
• Anestesiavdelingen,Rikshospitalet, 0027 Oslo. j.h.laake@basalmed.uio.no
• Tidsskr. Nor. Laegeforen. 2004 Mar 18;124(6):782-4.

BackgroundXigris (recombinant human activated protein C) has recently been introduced as a treatment for severe sepsis following a large multicentre trial (the PROWESS trial).Material And MethodsCritical review of the original paper, follow-up studies and commentaries, and subgroup analyses from the US Food and Drug Administration.ResultsChanges in trial design after the start of the trial as well as inconsistent results in two phases of the trial make interpretation difficult. The overall trial results indicate a small benefit from treatment with activated protein C. However, subgroup analysis reveals that several groups of patients appeared to have little benefit. The drug may have severe and potentially lethal side effects in some patients.InterpretationAlthough activated protein C may have beneficial effects in some patients with severe sepsis, the effect on different subgroups of patients remains to be clarified. We conclude that there is at present insufficient documentation for a recommendation of activated protein C in patients with severe sepsis.

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