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A prospective, observational study of Xigris Use in the United States (XEUS)

Abstract Background Use of pharmacologic agents in clinical practice may differ from the manner in which they were studied in rigorous randomized clinical trials. This was a prospective, observational, noninterventional study to determine the profile of patients receiving drotrecogin alfa (activated... Full description

Journal Title: Journal of critical care 2010, Vol.25 (4), p.660.e9-660.e16
Main Author: Steingrub, Jay S., MD
Other Authors: Cheatham, Michael L., MD , Woodward, Brad, MD , Wang, H. Tiffany, MS , Effron, Mark B., MD
Format: Electronic Article Electronic Article
Language: English
Subjects:
Publisher: United States: Elsevier Inc
ID: ISSN: 0883-9441
Link: https://www.ncbi.nlm.nih.gov/pubmed/20435433
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title: A prospective, observational study of Xigris Use in the United States (XEUS)
format: Article
creator:
  • Steingrub, Jay S., MD
  • Cheatham, Michael L., MD
  • Woodward, Brad, MD
  • Wang, H. Tiffany, MS
  • Effron, Mark B., MD
subjects:
  • Adult
  • Age Factors
  • Aged
  • Anti-Infective Agents - adverse effects
  • Anti-Infective Agents - therapeutic use
  • Clinical medicine
  • Clinical trials
  • Clinical Trials, Phase III as Topic
  • Comorbidity
  • Critical Care
  • Drotrecogin alfa (activated)
  • Female
  • Hospitals
  • Humans
  • Male
  • Medical colleges
  • Middle Aged
  • Mortality
  • Multiple Organ Failure - etiology
  • Practice Patterns, Physicians
  • Prospective Studies
  • Protein C
  • Protein C - adverse effects
  • Protein C - therapeutic use
  • Ratings & rankings
  • Recombinant Proteins - adverse effects
  • Recombinant Proteins - therapeutic use
  • Regulatory approval
  • Review boards
  • Risk Factors
  • Sepsis
  • Sepsis - complications
  • Sepsis - drug therapy
  • Sepsis - mortality
  • Severe sepsis
  • Treatment Outcome
  • United States
ispartof: Journal of critical care, 2010, Vol.25 (4), p.660.e9-660.e16
description: Abstract Background Use of pharmacologic agents in clinical practice may differ from the manner in which they were studied in rigorous randomized clinical trials. This was a prospective, observational, noninterventional study to determine the profile of patients receiving drotrecogin alfa (activated) in clinical practice, provide additional outcome and safety data, and allow for a comparison to patients studied in the phase 3 Protein C Worldwide Evaluation in Severe Sepsis (PROWESS) trial. Methods A total of 548 adult patients with severe sepsis were enrolled from 61 nonteaching or academically affiliated hospitals in the United States. Patients received drotrecogin alfa (activated) as part of physician-directed therapy for severe sepsis. Results The Xigris Use in the United States (XEUS) patients were younger (58 vs 63 years of age), had more comorbidities, and more sepsis-induced organ dysfunction at baseline compared to high-risk (Acute Physiology and Chronic Health Evaluation II score ≥ 25) PROWESS patients who received drotrecogin alfa (activated), (cardiovascular, 85.0% vs 79.7%; hematologic, 22.3% vs 16.4%; and renal, 57.9% vs 50.7%) (all P < .05). The XEUS patients had a higher mortality rate compared to high-risk PROWESS patients receiving drotrecogin alfa (activated) (36.7% vs 30.9%; P = .062) but a similar safety profile (infusion period serious bleeding, 2.7% vs 2.2%; P = .579; 28-day serious bleeding, 3.1% vs 3.9%; P = .520). The rate of intracranial hemorrhage in XEUS was 0.2%. Conclusions Patients receiving drotrecogin alfa (activated) in clinical practice were more acutely ill, had a higher mortality rate, but a similar safety profile with respect to serious bleeding events compared to the PROWESS trial.
language: eng
source:
identifier: ISSN: 0883-9441
fulltext: no_fulltext
issn:
  • 0883-9441
  • 1557-8615
url: Link


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titleA prospective, observational study of Xigris Use in the United States (XEUS)
creatorSteingrub, Jay S., MD ; Cheatham, Michael L., MD ; Woodward, Brad, MD ; Wang, H. Tiffany, MS ; Effron, Mark B., MD
creatorcontribSteingrub, Jay S., MD ; Cheatham, Michael L., MD ; Woodward, Brad, MD ; Wang, H. Tiffany, MS ; Effron, Mark B., MD ; for the XEUS investigators ; XEUS Investigators
descriptionAbstract Background Use of pharmacologic agents in clinical practice may differ from the manner in which they were studied in rigorous randomized clinical trials. This was a prospective, observational, noninterventional study to determine the profile of patients receiving drotrecogin alfa (activated) in clinical practice, provide additional outcome and safety data, and allow for a comparison to patients studied in the phase 3 Protein C Worldwide Evaluation in Severe Sepsis (PROWESS) trial. Methods A total of 548 adult patients with severe sepsis were enrolled from 61 nonteaching or academically affiliated hospitals in the United States. Patients received drotrecogin alfa (activated) as part of physician-directed therapy for severe sepsis. Results The Xigris Use in the United States (XEUS) patients were younger (58 vs 63 years of age), had more comorbidities, and more sepsis-induced organ dysfunction at baseline compared to high-risk (Acute Physiology and Chronic Health Evaluation II score ≥ 25) PROWESS patients who received drotrecogin alfa (activated), (cardiovascular, 85.0% vs 79.7%; hematologic, 22.3% vs 16.4%; and renal, 57.9% vs 50.7%) (all P < .05). The XEUS patients had a higher mortality rate compared to high-risk PROWESS patients receiving drotrecogin alfa (activated) (36.7% vs 30.9%; P = .062) but a similar safety profile (infusion period serious bleeding, 2.7% vs 2.2%; P = .579; 28-day serious bleeding, 3.1% vs 3.9%; P = .520). The rate of intracranial hemorrhage in XEUS was 0.2%. Conclusions Patients receiving drotrecogin alfa (activated) in clinical practice were more acutely ill, had a higher mortality rate, but a similar safety profile with respect to serious bleeding events compared to the PROWESS trial.
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subjectAdult ; Age Factors ; Aged ; Anti-Infective Agents - adverse effects ; Anti-Infective Agents - therapeutic use ; Clinical medicine ; Clinical trials ; Clinical Trials, Phase III as Topic ; Comorbidity ; Critical Care ; Drotrecogin alfa (activated) ; Female ; Hospitals ; Humans ; Male ; Medical colleges ; Middle Aged ; Mortality ; Multiple Organ Failure - etiology ; Practice Patterns, Physicians ; Prospective Studies ; Protein C ; Protein C - adverse effects ; Protein C - therapeutic use ; Ratings & rankings ; Recombinant Proteins - adverse effects ; Recombinant Proteins - therapeutic use ; Regulatory approval ; Review boards ; Risk Factors ; Sepsis ; Sepsis - complications ; Sepsis - drug therapy ; Sepsis - mortality ; Severe sepsis ; Treatment Outcome ; United States
ispartofJournal of critical care, 2010, Vol.25 (4), p.660.e9-660.e16
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descriptionAbstract Background Use of pharmacologic agents in clinical practice may differ from the manner in which they were studied in rigorous randomized clinical trials. This was a prospective, observational, noninterventional study to determine the profile of patients receiving drotrecogin alfa (activated) in clinical practice, provide additional outcome and safety data, and allow for a comparison to patients studied in the phase 3 Protein C Worldwide Evaluation in Severe Sepsis (PROWESS) trial. Methods A total of 548 adult patients with severe sepsis were enrolled from 61 nonteaching or academically affiliated hospitals in the United States. Patients received drotrecogin alfa (activated) as part of physician-directed therapy for severe sepsis. Results The Xigris Use in the United States (XEUS) patients were younger (58 vs 63 years of age), had more comorbidities, and more sepsis-induced organ dysfunction at baseline compared to high-risk (Acute Physiology and Chronic Health Evaluation II score ≥ 25) PROWESS patients who received drotrecogin alfa (activated), (cardiovascular, 85.0% vs 79.7%; hematologic, 22.3% vs 16.4%; and renal, 57.9% vs 50.7%) (all P < .05). The XEUS patients had a higher mortality rate compared to high-risk PROWESS patients receiving drotrecogin alfa (activated) (36.7% vs 30.9%; P = .062) but a similar safety profile (infusion period serious bleeding, 2.7% vs 2.2%; P = .579; 28-day serious bleeding, 3.1% vs 3.9%; P = .520). The rate of intracranial hemorrhage in XEUS was 0.2%. Conclusions Patients receiving drotrecogin alfa (activated) in clinical practice were more acutely ill, had a higher mortality rate, but a similar safety profile with respect to serious bleeding events compared to the PROWESS trial.
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titleA prospective, observational study of Xigris Use in the United States (XEUS)
authorSteingrub, Jay S., MD ; Cheatham, Michael L., MD ; Woodward, Brad, MD ; Wang, H. Tiffany, MS ; Effron, Mark B., MD
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abstractAbstract Background Use of pharmacologic agents in clinical practice may differ from the manner in which they were studied in rigorous randomized clinical trials. This was a prospective, observational, noninterventional study to determine the profile of patients receiving drotrecogin alfa (activated) in clinical practice, provide additional outcome and safety data, and allow for a comparison to patients studied in the phase 3 Protein C Worldwide Evaluation in Severe Sepsis (PROWESS) trial. Methods A total of 548 adult patients with severe sepsis were enrolled from 61 nonteaching or academically affiliated hospitals in the United States. Patients received drotrecogin alfa (activated) as part of physician-directed therapy for severe sepsis. Results The Xigris Use in the United States (XEUS) patients were younger (58 vs 63 years of age), had more comorbidities, and more sepsis-induced organ dysfunction at baseline compared to high-risk (Acute Physiology and Chronic Health Evaluation II score ≥ 25) PROWESS patients who received drotrecogin alfa (activated), (cardiovascular, 85.0% vs 79.7%; hematologic, 22.3% vs 16.4%; and renal, 57.9% vs 50.7%) (all P < .05). The XEUS patients had a higher mortality rate compared to high-risk PROWESS patients receiving drotrecogin alfa (activated) (36.7% vs 30.9%; P = .062) but a similar safety profile (infusion period serious bleeding, 2.7% vs 2.2%; P = .579; 28-day serious bleeding, 3.1% vs 3.9%; P = .520). The rate of intracranial hemorrhage in XEUS was 0.2%. Conclusions Patients receiving drotrecogin alfa (activated) in clinical practice were more acutely ill, had a higher mortality rate, but a similar safety profile with respect to serious bleeding events compared to the PROWESS trial.
copUnited States
pubElsevier Inc
pmid20435433
doi10.1016/j.jcrc.2010.03.009