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Brief Summary

GUIDELINE TITLE

Drotrecogin alfa (activated) for severe sepsis.

BIBLIOGRAPHIC SOURCE(S)

  • National Institute for Clinical Excellence (NICE). Drotrecogin alfa (activated) for severe sepsis. London (UK): National Institute for Clinical Excellence (NICE); 2004 Sep. 31 p. (Technology appraisal; no. 84).

GUIDELINE STATUS

This is the current release of the guideline.

** REGULATORY ALERT **

FDA WARNING/REGULATORY ALERT

Note from the National Guideline Clearinghouse: This guideline references a drug(s) for which important revised regulatory and/or warning information has been released.

  • April 21, 2005, Xigris: Eli Lilly and the U.S. Food and Drug Administration (FDA) notified healthcare professionals of the stopping of enrollment in a randomized, double-blind, placebo-controlled trial of Xigris in pediatric patients with severe sepsis. Xigris is not indicated for use in pediatric severe sepsis.
  • March 2005, Xigris (drotrecogin alfa [activated]): Eli Lilly and the FDA notified healthcare professionals about revisions to the WARNINGS section of labeling for Xigris [drotrecogin alfa (activated)], a biological therapeutic product indicated for the treatment of adult patients with severe sepsis who are at high risk of death.
  • April 21, 2005, Drotrecogin alfa (activated): The European Medicines Evaluation Agency (EMEA) recommended that drotrecogin alfa (activated) should only be used in high-risk patients, mainly in situations when therapy can be started within 24 hours of the onset of organ failure. In addition, it should only be used by experienced doctors in institutions skilled in the care of patients with severe sepsis. Drotrecogin alfa (activated) should not be used in patients with single organ dysfunction, especially if they have had recent surgery (within 30 days).

BRIEF SUMMARY CONTENT

 ** REGULATORY ALERT **
 RECOMMENDATIONS
 EVIDENCE SUPPORTING THE RECOMMENDATIONS
 IDENTIFYING INFORMATION AND AVAILABILITY
 DISCLAIMER

 Go to the Complete Summary

RECOMMENDATIONS

MAJOR RECOMMENDATIONS

Note from the National Guideline Clearinghouse (NGC) and the National Institute for Health and Clinical Excellence (NICE): Since the NICE guidance on drotrecogin alpha (activated) was issued, the European Medicines Evaluation Agency (EMEA) has recommended changes to the way that drotrecogin alpha (activated) should be used. Please see the "Regulatory Alert" field for more information. NICE advises that clinicians wishing to prescribe drotrecogin alpha (activated) should take the EMEA advice into account alongside the guidance from NICE when deciding whether or not to prescribe drotrecogin alpha (activated).

  • Drotrecogin alfa (activated) is recommended for use in adult patients who have severe sepsis that has resulted in multiple organ failure (that is, two or more major organs have failed) and who are being provided with optimum intensive care support.
  • The use of drotrecogin alfa (activated) should only be initiated and supervised by a specialist consultant with intensive care skills and experience in the care of patients with sepsis.

CLINICAL ALGORITHM(S)

None provided

EVIDENCE SUPPORTING THE RECOMMENDATIONS

TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

The type of evidence supporting the recommendations is not specifically stated.

IDENTIFYING INFORMATION AND AVAILABILITY

BIBLIOGRAPHIC SOURCE(S)

  • National Institute for Clinical Excellence (NICE). Drotrecogin alfa (activated) for severe sepsis. London (UK): National Institute for Clinical Excellence (NICE); 2004 Sep. 31 p. (Technology appraisal; no. 84).

ADAPTATION

Not applicable: The guideline was not adapted from another source.

DATE RELEASED

2004 Sep

GUIDELINE DEVELOPER(S)

National Institute for Health and Clinical Excellence (NICE) - National Government Agency [Non-U.S.]

SOURCE(S) OF FUNDING

National Institute for Health and Clinical Excellence (NICE)

GUIDELINE COMMITTEE

Appraisal Committee

COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

Dr Jane Adam, Radiologist, St George's Hospital, London; Professor Ron Akehurst, Dean of School of Health and Related Research, University of Sheffield; Dr Sunil Angris, General Practitioner, Waterhouses Medical Practice, Staffordshire; Professor David Barnett (Chair), Professor of Clinical Pharmacology, University of Leicester; Professor Stirling Bryan, Professor of Health Economics, Health Economics Facility, Health Services Management Centre, University of Birmingham; Professor John Cairns, Professor of Health Economics, Health Economics Research Unit, University of Aberdeen; Professor David Chadwick, Professor of Neurology, Department of Neurological Science, Walton Centre for Neurology & Neurosurgery, Liverpool; Ms Ailsa Claire, Chief Executive, Barnsley Primary Care Trust, South Yorkshire; Dr Lorna Duggan, Consultant Forensic Psychiatrist in Developmental Disabilities, St Andrew's Hospital, Northampton; Mrs Fiona Duncan, Clinical Nurse Specialist, Anaesthetic Department, Blackpool Victoria Hospital, Blackpool; Dr Paul Ewings, Statistician, Taunton & Somerset NHS Trust, Taunton; Mr Sanjay Gupta, Stroke Services Manager, Basildon & Thurrock University Hospitals NHS Trust; Professor Philip Home (Vice-Chair), Professor of Diabetes Medicine, Department of Medicine, University of Newcastle upon Tyne; Dr Peter Jackson, Clinical Pharmacologist, Molecular & Clinical Pharmacology, University of Sheffield; Dr Mike Laker, Medical Director, Newcastle Hospitals NHS Trust, Royal Victoria Infirmary, Newcastle upon Tyne; Professor Richard Lilford, Professor of Clinical Epidemiology, Department of Public Health and Epidemiology, University of Birmingham; Dr Simon Mitchell, Consultant Neonatal Paediatrician, St Mary's Hospital, Manchester; Dr Virginia Pearson, Chief Executive, South Petherton Hospital, South Somerset PCT; Dr Christa Roberts, Industry Representative, UK Manager Vascular Intervention, Guidant Ltd, Basingstoke, Hampshire; Dr Stephen Saltissi, Consultant Cardiologist, Royal Liverpool University Hospital; Dr Lindsay Smith, General Practitioner, Westlake Surgery, Somerset; Mr Mike Spencer, General Manager, Clinical Support Services, Cardiff and Vale NHS Trust; Dr Rod Taylor, Senior Lecturer, Department of Public Health & Epidemiology, University of Birmingham; Professor Norman Waugh, Department of Public Health, University of Aberdeen; Mrs Miranda Wheatley-Price, Lay Representative, Director of Service Development, Colon Cancer Concern, London

FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

Committee members are asked to declare any interests in the technology to be appraised. If it is considered there is a conflict of interest, the member is excluded from participating further in that appraisal.

GUIDELINE STATUS

This is the current release of the guideline.

GUIDELINE AVAILABILITY

Electronic copies: Available in Portable Document Format (PDF) from the National Institute for Health and Clinical Excellence (NICE) Web site.

Print copies: Available from the National Health Service (NHS) Response Line 0870 1555 455. 11 Strand, London, WC2N 5HR.

AVAILABILITY OF COMPANION DOCUMENTS

The following are available:

Print copies: Available from the National Health Service (NHS) Response Line 0870 1555 455. 11 Strand, London, WC2N 5HR.

Additionally, Audit Criteria can be found in Appendix C of the original guideline document.

PATIENT RESOURCES

The following is available:

Please note: This patient information is intended to provide health professionals with information to share with their patients to help them better understand their health and their diagnosed disorders. By providing access to this patient information, it is not the intention of NGC to provide specific medical advice for particular patients. Rather we urge patients and their representatives to review this material and then to consult with a licensed health professional for evaluation of treatment options suitable for them as well as for diagnosis and answers to their personal medical questions. This patient information has been derived and prepared from a guideline for health care professionals included on NGC by the authors or publishers of that original guideline. The patient information is not reviewed by NGC to establish whether or not it accurately reflects the original guideline's content.

NGC STATUS

COPYRIGHT STATEMENT

This NGC summary is based on the original guideline, which is subject to the guideline developer's copyright restrictions.

DISCLAIMER

NGC DISCLAIMER

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Readers with questions regarding guideline content are directed to contact the guideline developer.


 

 

   
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