Treatment of septic shock and use of drotrecogin alfa (activated) in children

This updated review found no evidence suggesting that APC should be used for treating patients with severe sepsis or septic shock. Additionally, APC is associated with a higher risk of bleeding. Unless additional RCTs provide evidence of a treatment effect, policy-makers, clinicians and academics should not promote the use of APC.Warning: On October 25th 2011, the European Medicines Agency issued a press release on the worldwide withdrawal of Xigris (activated protein C / drotrecogin alfa) from the market by Eli Lilly due to lack of beneficial effect on 28-day mortality in the PROWESS-SHOCK study. Furthermore, Eli Lily has announced the discontinuation of all other ongoing clinical trials. The final results of the PROWESS-SHOCK study are expected to be published in 2012. This systematic review will be updated when results of the PROWESS-SHOCK or other trials are published.

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Human recombinant protein C for severe sepsis and septic shock in adult and paediatric patients

Martí‐Carvajal¹,

Solà

Gluud

et al. 2012

Cochrane Database of Systematic Reviews

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This updated review found no evidence suggesting that APC should be used for treating patients with severe sepsis or septic shock. APC seems to be associated with a higher risk of bleeding. The drug company behind APC, Eli Lilly, has announced the discontinuation of all ongoing clinical trials using this drug for treating patients with severe sepsis or septic shock. APC should not be used for sepsis or septic shock outside randomized clinical trials.

show abstract

Treatment of septic shock and use of drotrecogin alfa (activated) in children

Abstract: "Death is often attributed to the comorbidities rather than to sepsis itself, resulting in nearly half of the deaths remaining unattributed to sepsis."

Cited by 3 publications

References 37 publications

Human recombinant activated protein C for severe sepsis

Human recombinant activated protein C for severe sepsis

Human recombinant activated protein C for severe sepsis

Human recombinant protein C for severe sepsis and septic shock in adult and paediatric patients

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