ArticleIntensive care medicine2007
Use of Drotrecogin alfa (activated) in Italian intensive care units: the results of a nationwide survey.
Article in Intensive care medicine, 2007. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 30 papers, 1 of them a synthesis that pooled it.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
30 citing papers in PubMed, 1 synthesis or guideline pooled it, 81 citations in OpenAlex.
- Human recombinant protein C for severe sepsis and septic shock in adult and paediatric patients.The Cochrane database of systematic reviews · 2012Pooled it
- Comprehensive safety analysis of concomitant drotrecogin alfa (activated) and prophylactic heparin use in patients with severe sepsis.Intensive care medicine · 2009Trial
- Pharmacogenomic biomarkers do not predict response to drotrecogin alfa in patients with severe sepsis.Annals of intensive care · 2018Article
- The efficacy of activated protein C for the treatment of sepsis: incorporating observational evidence with a Bayesian approach.BMJ open · 2015Article
- Why activated protein C was not successful in severe sepsis and septic shock: are we still tilting at windmills?Current infectious disease reports · 2013Article
- Evaluation of recombinant activated protein C for severe sepsis at a tertiary academic medical center.Therapeutics and clinical risk management · 2013Article
- Design, conduct, and analysis of a multicenter, pharmacogenomic, biomarker study in matched patients with severe sepsis treated with or without drotrecogin Alfa (activated).Annals of intensive care · 2012Article
- An update on activated protein C (xigris) in the management of sepsis.P & T : a peer-reviewed journal for formulary management · 2010Article
- Growing insights into the potential benefits and risks of activated protein C administration in sepsis: a review of preclinical and clinical studies.Biologics : targets & therapy · 2009Article
- The international PROGRESS registry of patients with severe sepsis: drotrecogin alfa (activated) use and patient outcomes.Critical care (London, England) · 2009Article
- Scientific and clinical challenges in sepsis.Current pharmaceutical design · 2009Review
- Dissociation of activated protein C functions by elimination of protein S cofactor enhancement.The Journal of biological chemistry · 2008Article
- Design, conduct, analysis and reporting of a multi-national placebo-controlled trial of activated protein C for persistent septic shock.Intensive care medicine · 2008Article
- Editors' comments on a new trial of activated protein C for persistent septic shock.Intensive care medicine · 2008Article
- Once is not enough: clinical trials in sepsis.Intensive care medicine · 2008Article
- Visiting policies in Italian intensive care units: a nationwide survey.Intensive care medicine · 2008Article
- Year in review in Intensive Care Medicine, 2007. II. Haemodynamics, pneumonia, infections and sepsis, invasive and non-invasive mechanical ventilation, acute respiratory distress syndrome.Intensive care medicine · 2008Review
- Drotrecogin alfa (activated): real-life use and outcomes for the UK.Critical care (London, England) · 2008Article
- Increased bleeding risk associated with the use of recombinant human activated protein C in patients with advanced liver disease.Critical care (London, England) · 2008Article
- Surviving Sepsis Campaign: international guidelines for management of severe sepsis and septic shock: 2008.Intensive care medicine · 2008Article
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Authors and funding
6 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo monitor the use of drotrecogin alfa activated (DrotAA) in Italy and its effects on patients' health.
designProspective pharmaco-surveillance program with a parallel non-randomized control group.
settingThe Ministry of Health required all intensive care units (ICUs) using DrotAA to participate in the pharmaco-surveillance program. Our control group was formed of patients eligible for treatment with DrotAA but who had not received it. PATIENTS AND
participantsThe data we collected included basic demographic characteristics, indications, modalities of use, adverse events, and ICU mortality. We identified potentially non-collaborating centres on the basis of data on DrotAA purchasing by hospitals. MEASUREMENTS AND
resultsFrom 2003 to 2006, 668 cases of treatment with DrotAA were reported. We estimate that 79.3% of all patients treated in Italy in this period were recruited. Off-label use was common. Delayed start was the main reason for off-label prescription. Bleeding during infusion occurred in 73 patients (10.9%). The ICU mortality was higher in patients with bleeding (57.5 vs. 44.9%; p=0.041). Crude ICU mortality was lower in patients receiving DrotAA than in controls (46.4 vs. 54.9%; p=0.0004); however, multivariate analysis, which adjusted for certain relevant differences, showed that DrotAA treatment was associated with higher mortality after scheduled surgery.
conclusionsThese results question the way in which the drug is used in everyday clinical practice and its efficacy in a selected subgroup, and reinforce the need for a new, independent, confirmatory trial to reassess the risk-to-benefit ratio of DrotAA.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.