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Cited by 6,132

The DOI matches its Crossref record; 2 of the 2 references it cites were found in a registry or an index.

Efficacy and Safety of Recombinant Human Activated Protein C for Severe Sepsis

Open access
Bernard, Gordon R., Vincent, Jean-Louis, Laterre, Pierre-Francois, LaRosa, Steven P., Dhainaut, Jean-Francois, Lopez-Rodriguez, Angel, Steingrub, Jay S., Garber, Gary E., Helterbrand, Jeffrey D., Ely, E. Wesley, Fisher, Charles J.·2001·New England Journal of Medicine
DOI 10.1056/nejm200103083441001
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Abstract

BACKGROUND: Drotrecogin alfa (activated), or recombinant human activated protein C, has antithrombotic, antiinflammatory, and profibrinolytic properties. In a previous study, drotrecogin alfa activated produced dose-dependent reductions in the levels of markers of coagulation and inflammation in patients with severe sepsis. In this phase 3 trial, we assessed whether treatment with drotrecogin alfa activated reduced the rate of death from any cause among patients with severe sepsis. METHODS: We conducted a randomized, double-blind, placebo-controlled, multicenter trial. Patients with systemic inflammation and organ failure due to acute infection were enrolled and assigned to receive an intravenous infusion of either placebo or drotrecogin alfa activated (24 microg per kilogram of body weight per hour) for a total duration of 96 hours. The prospectively defined primary end point was death from any cause and was assessed 28 days after the start of the infusion. Patients were monitored for adverse events; changes in vital signs, laboratory variables, and the results of microbiologic cultures; and the development of neutralizing antibodies against activated protein C. RESULTS: A total of 1690 randomized patients were treated (840 in the placebo group and 850 in the drotrecogin alfa activated group). The mortality rate was 30.8 percent in the placebo group and 24.7 percent in the drotrecogin alfa activated group. On the basis of the prospectively defined primary analysis, treatment with drotrecogin alfa activated was associated with a reduction in the relative risk of death of 19.4 percent (95 percent confidence interval, 6.6 to 30.5) and an absolute reduction in the risk of death of 6.1 percent (P=0.005). The incidence of serious bleeding was higher in the drotrecogin alfa activated group than in the placebo group (3.5 percent vs. 2.0 percent, P=0.06). CONCLUSIONS: Treatment with drotrecogin alfa activated significantly reduces mortality in patients with severe sepsis and may be associated with an increased risk of bleeding.

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Metadata

Authors
Bernard, G. R., Vincent, J.-L., Laterre, P.-F., LaRosa, S. P., Dhainaut, J.-F., Lopez-Rodriguez, A., Steingrub, J. S., Garber, G. E., Helterbrand, J. D., Ely, E. W., & Fisher, C. J.
Venue
New England Journal of Medicine
Publisher
Massachusetts Medical Society
Published
2001-03-08
Volume
344
Issue
10
Pages
699-709
ISSN
  • 0028-4793 (ISSN-L)
  • 1533-4406
DOI
10.1056/nejm200103083441001
OpenAlex
W2322121630
Cited by
6,132
References
2
FWCI
391.72
Type
journal article
Language
en
Open access
bronze

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Bibliographic data: Semantic Scholar, OpenAlex, Crossref.

Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).

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