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Statements

Subject Item
n2:RIV%2F00064173%3A_____%2F12%3A43907127%21RIV13-MZ0-00064173
rdf:type
skos:Concept n12:Vysledek
dcterms:description
There have been conflicting reports on the efficacy of recombinant human activated protein C, or drotrecogin alfa (activated) (DrotAA), for the treatment of patients with septic shock. METHODS In this randomized, double-blind, placebo-controlled, multicenter trial, we assigned 1697 patients with infection, systemic inflammation, and shock who were receiving fluids and vasopressors above a threshold dose for 4 hours to receive either DrotAA (at a dose of 24 mu g per kilogram of body weight per hour) or placebo for 96 hours. The primary outcome was death from any cause 28 days after randomization. RESULTS At 28 days, 223 of 846 patients (26.4%) in the DrotAA group and 202 of 834 (24.2%) in the placebo group had died (relative risk in the DrotAA group, 1.09; 95% confidence interval [CI], 0.92 to 1.28; P = 0.31). At 90 days, 287 of 842 patients (34.1%) in the DrotAA group and 269 of 822 (32.7%) in the placebo group had died (relative risk, 1.04; 95% CI, 0.90 to 1.19; P = 0.56). Among patients with severe protein C deficiency at baseline, 98 of 342 (28.7%) in the DrotAA group had died at 28 days, as compared with 102 of 331 (30.8%) in the placebo group (risk ratio, 0.93; 95% CI, 0.74 to 1.17; P = 0.54). Similarly, rates of death at 28 and 90 days were not significantly different in other predefined subgroups, including patients at increased risk for death. Serious bleeding during the treatment period occurred in 10 patients in the DrotAA group and 8 in the placebo group (P = 0.81). CONCLUSIONS DrotAA did not significantly reduce mortality at 28 or 90 days, as compared with placebo, in patients with septic shock. (Funded by Eli Lilly; PROWESS-SHOCK ClinicalTrials.gov number, NCT00604214.) There have been conflicting reports on the efficacy of recombinant human activated protein C, or drotrecogin alfa (activated) (DrotAA), for the treatment of patients with septic shock. METHODS In this randomized, double-blind, placebo-controlled, multicenter trial, we assigned 1697 patients with infection, systemic inflammation, and shock who were receiving fluids and vasopressors above a threshold dose for 4 hours to receive either DrotAA (at a dose of 24 mu g per kilogram of body weight per hour) or placebo for 96 hours. The primary outcome was death from any cause 28 days after randomization. RESULTS At 28 days, 223 of 846 patients (26.4%) in the DrotAA group and 202 of 834 (24.2%) in the placebo group had died (relative risk in the DrotAA group, 1.09; 95% confidence interval [CI], 0.92 to 1.28; P = 0.31). At 90 days, 287 of 842 patients (34.1%) in the DrotAA group and 269 of 822 (32.7%) in the placebo group had died (relative risk, 1.04; 95% CI, 0.90 to 1.19; P = 0.56). Among patients with severe protein C deficiency at baseline, 98 of 342 (28.7%) in the DrotAA group had died at 28 days, as compared with 102 of 331 (30.8%) in the placebo group (risk ratio, 0.93; 95% CI, 0.74 to 1.17; P = 0.54). Similarly, rates of death at 28 and 90 days were not significantly different in other predefined subgroups, including patients at increased risk for death. Serious bleeding during the treatment period occurred in 10 patients in the DrotAA group and 8 in the placebo group (P = 0.81). CONCLUSIONS DrotAA did not significantly reduce mortality at 28 or 90 days, as compared with placebo, in patients with septic shock. (Funded by Eli Lilly; PROWESS-SHOCK ClinicalTrials.gov number, NCT00604214.)
dcterms:title
Drotrecogin Alfa (Activated) in Adults with Septic Shock Drotrecogin Alfa (Activated) in Adults with Septic Shock
skos:prefLabel
Drotrecogin Alfa (Activated) in Adults with Septic Shock Drotrecogin Alfa (Activated) in Adults with Septic Shock
skos:notation
RIV/00064173:_____/12:43907127!RIV13-MZ0-00064173
n12:predkladatel
n17:ico%3A00064173
n3:aktivita
n11:N
n3:aktivity
N
n3:cisloPeriodika
22
n3:dodaniDat
n10:2013
n3:domaciTvurceVysledku
n7:2046245
n3:druhVysledku
n13:J
n3:duvernostUdaju
n14:S
n3:entitaPredkladatele
n6:predkladatel
n3:idSjednocenehoVysledku
132214
n3:idVysledku
RIV/00064173:_____/12:43907127
n3:jazykVysledku
n18:eng
n3:klicovaSlova
care; death; united-states; prowess trial; surgical-patients; protein-c; severe sepsis; apache-ii score; placebo-controlled trial; multiple-organ dysfunction
n3:klicoveSlovo
n4:apache-ii%20score n4:death n4:surgical-patients n4:severe%20sepsis n4:multiple-organ%20dysfunction n4:united-states n4:protein-c n4:prowess%20trial n4:care n4:placebo-controlled%20trial
n3:kodStatuVydavatele
US - Spojené státy americké
n3:kontrolniKodProRIV
[0801E0EAC23F]
n3:nazevZdroje
New England Journal of Medicine
n3:obor
n15:FI
n3:pocetDomacichTvurcuVysledku
1
n3:pocetTvurcuVysledku
242
n3:rokUplatneniVysledku
n10:2012
n3:svazekPeriodika
366
n3:tvurceVysledku
Pachl, Jan
n3:wos
000304613400005
s:issn
0028-4793
s:numberOfPages
10
n9:doi
10.1056/NEJMoa1202290