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Brief Summary

GUIDELINE TITLE

Ezetimibe for the treatment of primary (heterozygous-familial and non-familial) hypercholesterolaemia.

BIBLIOGRAPHIC SOURCE(S)

  • National Institute for Health and Clinical Excellence (NICE). Ezetimibe for the treatment of primary (heterozygous-familial and non-familial) hypercholesterolaemia. London (UK): National Institute for Health and Clinical Excellence (NICE); 2007 Nov. 30 p. (Technology appraisal guidance; no. 132).

GUIDELINE STATUS

This is the current release of the guideline.

BRIEF SUMMARY CONTENT

 
RECOMMENDATIONS
 EVIDENCE SUPPORTING THE RECOMMENDATIONS
 IDENTIFYING INFORMATION AND AVAILABILITY
 DISCLAIMER

 Go to the Complete Summary

RECOMMENDATIONS

MAJOR RECOMMENDATIONS

This guidance should be read in conjunction with National Institute for Health and Clinical Excellence (NICE) guidance on the initiation of statin therapy (NICE technology appraisal guidance 94) (see the National Guideline Clearinghouse [NGC] summary of the NICE technology appraisal, Statins for the prevention of cardiovascular events). NICE has published clinical guidelines on the management of blood pressure and blood lipids in people with type 2 diabetes (Inherited clinical guideline H) and secondary prevention for patients following a myocardial infarction (NICE clinical guideline 48) (see the NICE Web site). The following clinical guidelines are under development: lipid modification; familial hypercholesterolaemia; type 2 diabetes (update). This guidance should be read in the context of the relevant clinical guideline, when available.

  • Ezetimibe monotherapy is recommended as an option for the treatment of adults with primary (heterozygous-familial or non-familial) hypercholesterolaemia who would otherwise be initiated on statin therapy (as per NICE guidance TA 94 in adults with non-familial hypercholesterolaemia [see the NGC summary of the NICE technology appraisal, Statins for the prevention of cardiovascular events]) but who are unable to do so because of contraindications to initial statin therapy.
  • Ezetimibe monotherapy is recommended as an option for the treatment of adults with primary (heterozygous-familial or non-familial) hypercholesterolaemia who are intolerant to statin therapy (as defined below).
  • Ezetimibe, coadministered with initial statin therapy, is recommended as an option for the treatment of adults with primary (heterozygous-familial or non-familial) hypercholesterolaemia who have been initiated on statin therapy (as per NICE guidance TA 94 in adults with non-familial hypercholesterolaemia [see the NGC summary of the NICE technology appraisal, Statins for the prevention of cardiovascular events]) when:
    • Serum total or low-density lipoprotein (LDL) cholesterol concentration is not appropriately controlled (as defined below) either after appropriate dose titration of initial statin therapy or because dose titration is limited by intolerance to the initial statin therapy (as defined below)

      and

    • Consideration is being given to changing from initial statin therapy to an alternative statin.
  • When the decision has been made to treat with ezetimibe coadministered with a statin, ezetimibe should be prescribed on the basis of lowest acquisition cost.
  • For the purposes of this guidance, appropriate control of cholesterol concentrations should be based on individualised risk assessment in accordance with national guidance on the management of cardiovascular disease for the relevant populations.
  • For the purposes of this guidance, intolerance to initial statin therapy should be defined as the presence of clinically significant adverse effects from statin therapy that are considered to represent an unacceptable risk to the patient or that may result in compliance with therapy being compromised. Adverse effects include evidence of new-onset muscle pain (often associated with levels of muscle enzymes in the blood indicative of muscle damage), significant gastrointestinal disturbance or alterations of liver function tests.

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 Health and Clinical Excellence (NICE). Ezetimibe for the treatment of primary (heterozygous-familial and non-familial) hypercholesterolaemia. London (UK): National Institute for Health and Clinical Excellence (NICE); 2007 Nov. 30 p. (Technology appraisal guidance; no. 132).

ADAPTATION

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

DATE RELEASED

2007 Nov

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

Committee Members: Dr Jane Adam, Radiologist, St George's Hospital, London; Professor A E Ades, MRC Senior Scientist, MRC Health Services Research Collaboration, Department of Social Medicine, University of Bristol; Dr Amanda Adler, Consultant Physician, Addenbrooke's Hospital, Cambridge; Anne Allison, Nurse Clinical Adviser, Healthcare Commission; Dr Tom Aslan, General Practitioner, Stockwell, London; Professor David Barnett (Chair) Professor of Clinical Pharmacology, University of Leicester; Mrs Elizabeth Brain, Lay Member; Professor John Cairns (Committee B) Public Health and Policy, London School of Hygiene and Tropical Medicine; Professor Karl Claxton, Professor of Health Economics, University of York; Dr Richard Cookson, Senior Lecturer in Health Economics, School of Medicine Health Policy and Practice, University of East Anglia; Mrs Fiona Duncan, Clinical Nurse Specialist, Anaesthetic Department, Blackpool Victoria Hospital, Blackpool; Professor Christopher Eccleston, Director, Pain Management Unit, University of Bath; Dr Paul Ewings, Statistician, Taunton & Somerset NHS Trust, Taunton; Professor John Geddes, Professor of Epidemiological Psychiatry, University of Oxford; Mr John Goulston, Director of Finance, Barts and the London NHS Trust; Mr Adrian Griffin, Health Outcomes Manager, Johnson & Johnson Medical Ltd; Ms Linda Hands, Consultant Surgeon, John Radcliffe Hospital; Dr Rowan Hillson, Consultant Physician, Diabeticare, The Hillingdon Hospital; Professor Philip Home (Vice Chair) Professor of Diabetes Medicine, University of Newcastle upon Tyne; Dr Terry John, General Practitioner, The Firs, London; Professor Richard Lilford, Professor of Clinical Epidemiology, Department of Public Health and Epidemiology, University of Birmingham; Dr Simon Maxwell, Senior Lecturer in Clinical Pharmacology and Honorary Consultant Physician, Queens Medical Research Institute, University of Edinburgh; Ms Judith Paget, Chief Executive, Caerphilly Local Health Board, Wales; Dr Ann Richardson, Lay Member; Mr Mike Spencer, General Manager, Clinical Support Services, Cardiff and Vale NHS Trust; Dr Simon Thomas, Consultant Physician, General Medicine and Clinical Pharmacology, Newcastle Hospitals NHS Trust; Mr David Thomson, Lay Member; Dr Luke Twelves, General Practitioner, Ramsey Health Centre, North Huntingdon; Dr Norman Vetter, Reader, Department of Epidemiology, Statistics and Public Health, College of Medicine, University of Wales, Cardiff; Professor Mary Watkins, Professor of Nursing, University of Plymouth; Dr Paul Watson, Director of Commissioning, East of England Strategic Health Authority

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

AVAILABILITY OF COMPANION DOCUMENTS

The following are available:

Print copies: Available from the National Health Service (NHS) Response Line 0870 1555 455. ref: N1402. 11 Strand, London, WC2N 5HR.

PATIENT RESOURCES

The following is available:

  • Ezetimibe for the treatment of primary (heterozygous-familial and non-familial) hypercholesterolaemia. Understanding NICE guidance - Information for people who use NHS services. London (UK): National Institute for Health and Clinical Excellence (NICE); 2007 Nov. 4 p. (Technology appraisal 132).

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 NHS Response Line 0870 1555 455. ref: N1403. 11 Strand, London, WC2N 5HR.

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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