Strategies to optimize drotrecogin alfa (activated) use: Guidelines and therapeutic controversies

Pharmacotherapy

Volumn 22, Issue 12 II, 2002, Pages

  Cohen, Henry ^a   Welage, Lynda S ^b  

^a LONG ISLAND UNIVERSITY   (United States)

^b UNIVERSITY OF MICHIGAN HEALTH SYSTEM   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ACETYLSALICYLIC ACID; ANTITHROMBOCYTIC AGENT; DROTRECOGIN; HEPARIN; SODIUM;

BLEEDING; CLINICAL TRIAL; CONTINUOUS INFUSION; COST MINIMIZATION ANALYSIS; DEATH; DIAGNOSTIC PROCEDURE; DILUTION; DRUG BIOAVAILABILITY; DRUG EFFICACY; DRUG LABELING; DRUG MIXTURE; DRUG RESPONSE; DRUG STORAGE; DRUG SYNTHESIS; DRUG USE; EARLY DIAGNOSIS; EDUCATION; EVIDENCE BASED MEDICINE; FLUID RETENTION; HUMAN; PHARMACIST; PRACTICE GUIDELINE; REVIEW; SEPSIS; SODIUM LOAD; SODIUM RESTRICTION; SYSTEMIC INFLAMMATORY RESPONSE SYNDROME; TOXICITY; TREATMENT CONTRAINDICATION; TREATMENT INDICATION; TREATMENT PLANNING;

EID: 0036894217     PISSN: 02770008     EISSN: None     Source Type: Journal    
DOI: 10.1592/phco.22.18.223s.33706     Document Type: Review

References (21)

1. Natanson C, Sposito CJ, Banks SM. The sirens' song of confirmatory sepsis trials. Crit Care Med 1998;26:1927-31.
2. Angus DC, Linde-Zwirble WT, Lidicker J. Epidemiology of severe sepsis in the United States: Analysis of incidence, outcome, and associated costs of care. Crit Care Med 2001;29:1303-10.
3. Bernard GR, Vincent JL, Laterre PF, et al, for the Recombinant Human Activated Protein C Worldwide Evaluation in Severe Sepsis (PROWESS) Study Group. Efficacy and safety of recombinant human activated protein C for severe sepsis. N Engl J Med 2001;344:699-709.
4. U.S. Food and Drug Administration. Product Approval Information. Center for Biologics Evaluation and Research page. Available from www.fda.gov/cber/approvltr/ droteli11201L.pdf. Accessed September 3, 2002.
5. Eli Lilly and Company. Xigris (Drotrecogin Alfa [Activated]) Package Insert. Indianapolis, IN; 2001.
6. Cohen HE, ed. Drug Topics Red Book. Montvale, NJ: Medical Economics Company, 2002.
7. American Society of Health-System Pharmacists. ASHP guidelines for formulary system management. Am J Health-Syst Pharm 1992;49:648-52.
8. Moore SR. Pharmacy implications of clinical guideline development. Am J Health-Syst Pharm 1992;49:1763-4.
9. Bone RC, Balk RA, Cerra FB, et al. Definitions for sepsis and organ failure and guidelines for the use of innovative therapies in sepsis. The ACCP/SCCM consensus conference committee. American College of Chest Physicians/Society of Critical Care Medicine. Chest 1992;101:1644-55.
10. Balk RA. Severe sepsis and septic shock: Definitions, epidemiology and clinical manifestations. Crit Care Clin 2000;16:179-92.
11. Castle SC, Norman DC, Yeh M, Miller D, Yoshikawa T. Fever response in elderly nursing home residents: Are the older truly colder? J Am Geriatr Soc 1991:39:853-7.
12. Swift CG. Pharmacodynamics: Changes in homeostatic mechanisms, receptor and target organ sensitivity in the elderly Br Med Bull 1990;46:36-52.
13. Banez EI. Hematologic response to acute inflammation: The band neutrophil revisited. Tex Med 1990;86:26-8.
14. Civetta JM, Hudson-Civetta JA, Nelson LD. Evaluation of APACHE II for cost containment and quality assurance. Ann Surg 1990;212:266-74.
15. Knaus WA, Draper EA, Wagner DP, Zimmerman JE. APACHE II: A severity of disease classification system. Crit Care Med 1985;13:818-29.
16. Inverso SM, Cohen M, Antman EM, Spinler SA. Safety and efficacy of unfractionated heparin versus enoxaparin in obese patients and patients with severe renal impairment: Analysis from the ESSENCE and TIMI 11B studies [abstr]. J Am Coll Card 2001;37(suppl A):A365.
17. Levine MN, Raskob G, Landefeld S, Kearon C. Hemorrhagic complications of anticoagulant treatment. Chest 2001;119: S108-21.
18. Fragmin and Fast Revascularization During Instability in Coronary Artery Disease (FRISC II) Investigators. Long term low molecular mass heparin in unstable coronary artery disease: FRISC II prospective randomized multicenter study. Lancet 1999;354:701-7.
19. U.S. Food and Drug Administration. Drotrecogin Alfa (Activated) Slide Presentation Presented to the Anti-Infective Advisory Committee, October 16, 2001. Available from www.fda.gov/ohrms/dockets/ac/01/slides/3793s1_01_Lilly-CORE. Accessed September 3, 2002.
20. Eli Lilly and Company. Xigris™ Dosing Tools. Available from www.aboutxigris.com/dose_tools.shtml. Accessed September 3, 2002.
21. Bernard GR, Ely EW, Wright TJ, et al. Safety and dose relationship of recombinant human activated protein C for coagulopathy in severe sepsis. Crit Care Med 2001;29:2051-9.