Drotrecogin alfa (activated) in the treatment of severe sepsis patients with multiple-organ dysfunction: Data from the PROWESS trial

Objective: Based on the results of the PROWESS trial the European Agency for the Evaluation of Medicinal Products has recently approved drotrecogin alfa (activated) for treatment of adult patients with severe sepsis and multiple-organ failure. We report study's data on efficacy and safety in pa...

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Autores: Dhainaut, JF, Laterre, PF, Janes, JM, Bernard, GR, Artigas, A, Bakker, J, Riess, H, Basson, BR, Charpentier, J, Utterback, BG, Vincent, JL
Tipo de documento: artigo
Estado:Versão publicada
Data de publicação:2003
País:España
Recursos:Institut d'Investigació i Innovació Parc Taulí (I3PT)
Repositório:r-I3PT. Repositorio Institucional Producción Científica del Institut d'Investigació i Innovació Parc Taulí
OAI Identifier:oai:i3pt.fundanetsuite.com:p4711
Acesso em linha:https://i3pt.portalinvestigacion.com/publicaciones/4711
Access Level:Acceso aberto
Palavra-chave:Drotrecogin alfa (activated)
activated protein C
xigris
recombinant proteins
sepsis
septic shock
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spelling Drotrecogin alfa (activated) in the treatment of severe sepsis patients with multiple-organ dysfunction: Data from the PROWESS trialDhainaut, JFLaterre, PFJanes, JMBernard, GRArtigas, ABakker, JRiess, HBasson, BRCharpentier, JUtterback, BGVincent, JLDrotrecogin alfa (activated)activated protein Cxigrisrecombinant proteinssepsisseptic shockObjective: Based on the results of the PROWESS trial the European Agency for the Evaluation of Medicinal Products has recently approved drotrecogin alfa (activated) for treatment of adult patients with severe sepsis and multiple-organ failure. We report study's data on efficacy and safety in patients with multiple-organ dysfunction. Design and setting: Randomized, double-blind, placebo-controlled, multicenter trial in 164 medical centers. Patients: 1271 patients (75.2% of the intention-to-treat population, n=1690) with multiple-organ dysfunction at study entry. Interventions: Drotrecogin alfa (activated) n=634, 24 mug/kg per hour for 96 h or placebo (n=637). Results Observed 28-day mortality was significantly lower with drug treatment than with placebo (26.5%vs. 33.9%), cardiovascular and respiratory organ dysfunction resolved more rapidly over the first 7 days, and serious bleeding events were more frequent (2.4% vs. 1.3%). Conclusions: Treatment with drotrecogin alfa (activated) significantly reduced 28-day mortality and more quickly resolved cardiovascular and respiratory organ dysfunction. The difference in serious bleeding event rates may be clinically significant; however, the overall benefit-risk profile appears favorable.SPRINGER2003info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttps://i3pt.portalinvestigacion.com/publicaciones/4711INTENSIVE CARE MEDICINEISSN: 03424642ISSNe: 14321238reponame:r-I3PT. Repositorio Institucional Producción Científica del Institut d'Investigació i Innovació Parc Taulíinstname:Institut d'Investigació i Innovació Parc Taulí (I3PT)Inglésinfo:eu-repo/semantics/openAccessoai:i3pt.fundanetsuite.com:p47112026-06-21T15:30:37Z
dc.title.none.fl_str_mv Drotrecogin alfa (activated) in the treatment of severe sepsis patients with multiple-organ dysfunction: Data from the PROWESS trial
title Drotrecogin alfa (activated) in the treatment of severe sepsis patients with multiple-organ dysfunction: Data from the PROWESS trial
spellingShingle Drotrecogin alfa (activated) in the treatment of severe sepsis patients with multiple-organ dysfunction: Data from the PROWESS trial
Dhainaut, JF
Drotrecogin alfa (activated)
activated protein C
xigris
recombinant proteins
sepsis
septic shock
title_short Drotrecogin alfa (activated) in the treatment of severe sepsis patients with multiple-organ dysfunction: Data from the PROWESS trial
title_full Drotrecogin alfa (activated) in the treatment of severe sepsis patients with multiple-organ dysfunction: Data from the PROWESS trial
title_fullStr Drotrecogin alfa (activated) in the treatment of severe sepsis patients with multiple-organ dysfunction: Data from the PROWESS trial
title_full_unstemmed Drotrecogin alfa (activated) in the treatment of severe sepsis patients with multiple-organ dysfunction: Data from the PROWESS trial
title_sort Drotrecogin alfa (activated) in the treatment of severe sepsis patients with multiple-organ dysfunction: Data from the PROWESS trial
dc.creator.none.fl_str_mv Dhainaut, JF
Laterre, PF
Janes, JM
Bernard, GR
Artigas, A
Bakker, J
Riess, H
Basson, BR
Charpentier, J
Utterback, BG
Vincent, JL
author Dhainaut, JF
author_facet Dhainaut, JF
Laterre, PF
Janes, JM
Bernard, GR
Artigas, A
Bakker, J
Riess, H
Basson, BR
Charpentier, J
Utterback, BG
Vincent, JL
author_role author
author2 Laterre, PF
Janes, JM
Bernard, GR
Artigas, A
Bakker, J
Riess, H
Basson, BR
Charpentier, J
Utterback, BG
Vincent, JL
author2_role author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv Drotrecogin alfa (activated)
activated protein C
xigris
recombinant proteins
sepsis
septic shock
topic Drotrecogin alfa (activated)
activated protein C
xigris
recombinant proteins
sepsis
septic shock
description Objective: Based on the results of the PROWESS trial the European Agency for the Evaluation of Medicinal Products has recently approved drotrecogin alfa (activated) for treatment of adult patients with severe sepsis and multiple-organ failure. We report study's data on efficacy and safety in patients with multiple-organ dysfunction. Design and setting: Randomized, double-blind, placebo-controlled, multicenter trial in 164 medical centers. Patients: 1271 patients (75.2% of the intention-to-treat population, n=1690) with multiple-organ dysfunction at study entry. Interventions: Drotrecogin alfa (activated) n=634, 24 mug/kg per hour for 96 h or placebo (n=637). Results Observed 28-day mortality was significantly lower with drug treatment than with placebo (26.5%vs. 33.9%), cardiovascular and respiratory organ dysfunction resolved more rapidly over the first 7 days, and serious bleeding events were more frequent (2.4% vs. 1.3%). Conclusions: Treatment with drotrecogin alfa (activated) significantly reduced 28-day mortality and more quickly resolved cardiovascular and respiratory organ dysfunction. The difference in serious bleeding event rates may be clinically significant; however, the overall benefit-risk profile appears favorable.
publishDate 2003
dc.date.none.fl_str_mv 2003
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv https://i3pt.portalinvestigacion.com/publicaciones/4711
url https://i3pt.portalinvestigacion.com/publicaciones/4711
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.publisher.none.fl_str_mv SPRINGER
publisher.none.fl_str_mv SPRINGER
dc.source.none.fl_str_mv INTENSIVE CARE MEDICINE
ISSN: 03424642
ISSNe: 14321238
reponame:r-I3PT. Repositorio Institucional Producción Científica del Institut d'Investigació i Innovació Parc Taulí
instname:Institut d'Investigació i Innovació Parc Taulí (I3PT)
instname_str Institut d'Investigació i Innovació Parc Taulí (I3PT)
reponame_str r-I3PT. Repositorio Institucional Producción Científica del Institut d'Investigació i Innovació Parc Taulí
collection r-I3PT. Repositorio Institucional Producción Científica del Institut d'Investigació i Innovació Parc Taulí
repository.name.fl_str_mv
repository.mail.fl_str_mv
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score 15,812455

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