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N Engl J Med. 2012 May 31;366(22):2055-64. doi: 10.1056/NEJMoa1202290. Epub 2012 May 22.

Drotrecogin alfa (activated) in adults with septic shock.

Collaborators (244)

Ranieri V, Thompson B, Barie PS, Dhainaut JF, Douglas IS, Finfer S, Gårdlund B, Marshall JC, Rhodes A, Janes J, Macias WL, Vangerow B, Williams MD, Slutsky AS, Guyatt G, Angus D, Evans T, Carroll R, Weijer C, Boots R, Ernest D, Harrigan P, Chapman M, Bellomo R, Finfer S, Wright C, Crozier T, Davies A, French C, Orford N, Leditschke A, Reade M, MacIsaac C, Dugernier T, Jorens P, Vander Laenen M, Malbrain M, Meersseman W, Stockman W, Damas F, Raemaekers J, Dive AM, Damas P, Rogiers P, Laterre PF, Lobo SM, Auler JO Jr, Carvalho CM, Caldeira M, Dias FS, de Carvalho FB, Machado F, Aslanian P, Guimond JG, Ferguson N, Zuege D, Zuege D, Chittock D, Dhingra V, Chittock D, Rico P, Kumar A, Paunovic B, Fowler R, Lesur O, Anderson W, Sne N, Light R, Sramek V, Neiser J, Pachl J, Sevcik P, Burget I, Cerny V, Parizkova R, Kasal E, Balik M, Dlouhy P, Tenhunen J, Kurola J, Parviainen I, Laru-Sompa R, Loisa P, Kuitunen A, Pettila V, Kaukonen M, Saarinen K, Santré C, Hilbert G, Azoulay E, Mentec H, Levy B, Villers D, Bernardin G, Payen D, Diehl JL, Montravers P, Duranteau J, Cohen Y, Malledant Y, LePape A, Zéni F, Lefrant JY, Quenot JP, Durand-Gasselin J, Guiot P, Ferrandiere M, Le Tulzo Y, Lu Q, Jaber S, Gatécel C, Asehnoune K, de Jonghe B, Ricome JL, Asfar P, Francois B, Desachy A, Mercier E, Martin-Lefèvre L, Robert R, Allaouchiche B, Gerlach H, Motsch J, Jaschinski U, Kuhlen R, Kubitza S, Kluge S, Barth J, Marx G, Hartl W, Weiler N, Jog S, Gadkari M, Gupta R, Chopra VK, Varma A, Oomman A, Reddy R, Singh O, Thacker H, Ramesh MK, Tulli G, Fumagalli R, Gagliardi G, Ranieri M, Urbino R, Minoja G, Panascia B, Castiglione G, Salaris D, Antonelli M, Della Corte F, Poblano Morales MN, Aguirre Sanchez JS, Aguilera Almazán FD, Domínguez Cherit JG, Henderson S, Ure R, Van Haren F, McArthur C, Williams T, Moreno R, Póvoa P, Paiva JA, Catorze N, Blanco J, Ruiz-Rodriguez JC, Alvarez F, Rello J, Rodriguez A, Lopez MJ, Perez C, Betbese A, Artigas A, Ibanez J, Ruiz-Santana S, Gomez JI, Rico J, Sanchez M, Esteban A, Gonzalez G, Cambronero J, Sirgo G, Claramonte R, Guzman T, Maggiorini M, Kleger GR, Malacrida R, van Leeuwen H, van Zanten A, Pickkers P, Schouten J, Mallick A, Quasim T, Zuleika M, Sarkar P, Pogson D, MacNaughton P, Rhodes A, Whitehouse T, Margarson M, Jonas M, Bewley J, Arawwawala D, McLellan S, Davidson A, Harris RS, Samuel J, Birkhahn R, Willms D, Ardolic B, Hahn B, Douglas I, Albert R, Charchaflieh J, Djurkovic S, Barney J, Striker D, Koura F, McNellis M, Chang S, Frendl G, Morrison C, Kelly M, Dishman K, Anzueto A, Hagg D, Barram M, Ettinger N, Fruci C, Bayasi G, Kumar A, Abel W, Tanios M, Wunderink R, Rains R, Young B, Bekemeyer W, Krell K, Lo T, Wright P, Wilson M, Rains R, Wright P.

Abstract

BACKGROUND:

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 μg 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.).

PMID:
22616830
[PubMed - indexed for MEDLINE]
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