90-Day Follow-Up of Patients Treated With Drotrecogin Alfa (Activated) for Severe Sepsis: A Belgian Open Label Study

Decruyenaere, Johan; Backer, Daniel De; Spapen, Herbert; Laterre, Pierre‐François; Raemaekers, Jan; Rogiers, Peter; Trine, H; Sartral, Magali; Haentjens, T.; Wagner, Thomas

doi:10.1179/acb.2009.005

Cited by 7 publications

(2 citation statements)

References 12 publications

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“…In addition to ENHANCE and XPRESS, there have been a series of reports regarding clinical experience with rhAPC following completion of PROWESS and approval of the agent 86,[88][89][90][97][98][99][100][101][102][103][104] (Table 2). Some have been conducted with support from the manufacturer of rhAPC (n = 5) and others have been independent studies (n = 7).…”

Section: Other Uncontrolled Studiesmentioning

confidence: 99%

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Growing insights into the potential benefits and risks of activated protein C administration in sepsis: a review of preclinical and clinical studies

Altaweel¹

2009

BTT

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Recombinant human activated protein C (rhAPC) was developed to reduce excessive coagulant and inflammatory activity during sepsis. Basic and clinical research has suggested these pathways contribute to the pathogenesis of this lethal syndrome and are inhibited by rhAPC. Based in large part on the results of a single multicenter randomized controlled trial, rhAPC was first approved in 2001 by the US Food and Drug Administration (FDA) as adjunctive therapy in septic patients with a high risk of death. This was followed closely by approval in Europe, Australia, and New Zealand. At the original FDA review of rhAPC, concerns were raised as to whether a confirmatory trial should be done before final regulatory approval because of concerns that rhAPCs bleeding risk might outweigh its potential benefit during clinical use. Since 2001, continuing basic and clinical research has further elucidated the complex role activated protein C may have in both adaptive and maladaptive responses during sepsis. Moreover, subsequent controlled trials in other types of septic patients and observational studies appear to support earlier concerns that the benefit-to-risk ratio of rhAPC may not support its clinical use. This experience has prompted additional trials presently underway, to define whether treatment with rhAPC as it was originally indicated in septic patients with persistent shock, is safe and effective. Until such trials are complete, physicians employing this agent must carefully consider which patients may be appropriate candidates for rhAPC administration.

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Section: Other Uncontrolled Studiesmentioning

confidence: 99%

“…90 In the majority of the remaining studies, the incidence of serious bleeding events and of ICH in particular were higher than in PROWESS either during infusion or the entire period of follow-up Table 3) ( Figure 5). 73,[86][87][88][89][97][98][99][101][102][103][104]…”

Section: Other Uncontrolled Studiesmentioning

confidence: 99%

Growing insights into the potential benefits and risks of activated protein C administration in sepsis: a review of preclinical and clinical studies

Altaweel¹

2009

BTT

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Human recombinant activated protein C for severe sepsis

Martí‐Carvajal¹,

Solà²,

Lathyris³

et al. 2011

Cochrane Database of Systematic Reviews

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Human recombinant activated protein C for severe sepsis

Martí‐Carvajal

Solà²,

Lathyris

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. 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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90-Day Follow-Up of Patients Treated With Drotrecogin Alfa (Activated) for Severe Sepsis: A Belgian Open Label Study

Abstract: Despite a higher severity of illness at baseline, this phase IV open-label long-term study in Belgian ICUs shows consistent results with previous studies with DAA. Importantly, most of the surviving patients at day 90 were staying at home.

Cited by 7 publications

References 12 publications

Growing insights into the potential benefits and risks of activated protein C administration in sepsis: a review of preclinical and clinical studies

Growing insights into the potential benefits and risks of activated protein C administration in sepsis: a review of preclinical and clinical studies

Human recombinant activated protein C for severe sepsis

Human recombinant activated protein C for severe sepsis

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