Literature DB >> 18386762

A registry of patients treated with drotrecogin alfa (activated) in Belgian intensive care units--an observational study.

J L Vincent1, P F Laterre, J Decruyenaere, H Spapen, J Raemaekers, F Damas, P Rogiers, M Sartral, T Haentjens, D Nelson, J Janes.   

Abstract

BACKGROUND: Drotrecogin alfa (activated) [DrotAA] is the only specific sepsis therapy that has been shown to reduce mortality. The objectives of this study were to document the profile of patients treated with DrotAA in Belgian intensive care units (ICUs), using data from a database established as part of drug reimbursement conditions in Belgium, and to compare the observed hospital mortality of these patients with their expected mortality, calculated using data from non-DrotAA-treated patients from the Belgian section of PROGRESS, a separate, voluntary, international sepsis registry collecting data from patients with severe sepsis.
MATERIAL AND METHODS: Data from the non-DrotAA-treated patients in PROGRESS were used to calculate the expected mortality rates for DrotAA-treated patients in the Belgian registry. Using a logistic regression equation, these rates were controlled for age and the presence or absence of organ dysfunction in each of 5 organ systems. The same logistic regression technique was used to control the mortality rates observed in the DrotAA-treated patients from the Belgian registry for age and the presence or absence of each of the 5 organ dysfunctions. Adjusted expected and observed hospital mortality rates could then be compared.
RESULTS: There were 436 DrotAA patients in the Belgian registry. Almost all the patients (99.5%) had at least 2 organ failures and the hospital mortality was 51.6%. Two hundred and eighty-six of the patients had enough baseline data to be included in the regression model. Using data from the PROGRESS non-DrotAA patients, the predicted hospital mortality, controlled for age and organ dysfunction, of Belgian registry patients, had they not been treated with DrotAA, was 63.5%. The observed hospital mortality, again controlled for age and organ dysfunction, of the 286 Belgian registry patients was 50.7%, implying an adjusted absolute mortality reduction of 12.8%.
CONCLUSIONS: Comparing Belgian reimbursement registry data with those of a voluntary severe sepsis register provides support for the observation that DrotAA reduces mortality rates in severe sepsis and septic shock.

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Year:  2008        PMID: 18386762     DOI: 10.1179/acb.2008.004

Source DB:  PubMed          Journal:  Acta Clin Belg        ISSN: 1784-3286            Impact factor:   1.264


  11 in total

1.  The international PROGRESS registry of patients with severe sepsis: drotrecogin alfa (activated) use and patient outcomes.

Authors:  Greg Martin; Frank M Brunkhorst; Jonathan M Janes; Konrad Reinhart; David P Sundin; Kassandra Garnett; Richard Beale
Journal:  Crit Care       Date:  2009-06-30       Impact factor: 9.097

2.  Current role of activated protein C therapy for severe sepsis and septic shock.

Authors:  Philip S Barie
Journal:  Curr Infect Dis Rep       Date:  2008-09       Impact factor: 3.725

3.  Why activated protein C was not successful in severe sepsis and septic shock: are we still tilting at windmills?

Authors:  Peggy S Lai; B Taylor Thompson
Journal:  Curr Infect Dis Rep       Date:  2013-10       Impact factor: 3.725

4.  Comprehensive safety analysis of concomitant drotrecogin alfa (activated) and prophylactic heparin use in patients with severe sepsis.

Authors:  Mitchell Levy; Marcel Levi; Mark D Williams; Massimo Antonelli; Dazhe Wang; Mariano Alejandro Mignini
Journal:  Intensive Care Med       Date:  2009-04-15       Impact factor: 17.440

5.  Design, conduct, and analysis of a multicenter, pharmacogenomic, biomarker study in matched patients with severe sepsis treated with or without drotrecogin Alfa (activated).

Authors:  Djillali Annane; Jean Paul Mira; Lorraine B Ware; Anthony C Gordon; Jonathan Sevransky; Frank Stüber; Patrick J Heagerty; Hugh F Wellman; Mauricio Neira; Alexandra Dj Mancini; James A Russell
Journal:  Ann Intensive Care       Date:  2012-06-13       Impact factor: 6.925

Review 6.  Drotrecogin alfa (activated)...a sad final fizzle to a roller-coaster party.

Authors:  Derek C Angus
Journal:  Crit Care       Date:  2012-02-06       Impact factor: 9.097

7.  The efficacy of activated protein C for the treatment of sepsis: incorporating observational evidence with a Bayesian approach.

Authors:  Zhongheng Zhang
Journal:  BMJ Open       Date:  2015-01-16       Impact factor: 2.692

8.  Growing insights into the potential benefits and risks of activated protein C administration in sepsis: a review of preclinical and clinical studies.

Authors:  Laith Altaweel; Daniel Sweeney; Xizhong Cui; Amisha Barochia; Charles Natanson; Peter Q Eichacker
Journal:  Biologics       Date:  2009-09-15

9.  The essential nature of healthcare databases in critical care medicine.

Authors:  Greg S Martin
Journal:  Crit Care       Date:  2008-09-01       Impact factor: 9.097

10.  Drotrecogin alfa (activated): real-life use and outcomes for the UK.

Authors:  Kathryn M Rowan; Catherine A Welch; Emma North; David A Harrison
Journal:  Crit Care       Date:  2008-04-22       Impact factor: 9.097

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