Technology Appraisal Guidance No. 132
Source: National Institute for Health and Care Excellence
NOTE: This guidance has been replaced by NICE technology appraisal guidance 385.
This guidance should be read in conjunction with NICE guidance on the initiation of statin therapy (NICE technology appraisal guidance 94). 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). 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.
1.1 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) but who are unable to do so because of contraindications to initial statin therapy.
1.2 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 in section 1.6).
1.3 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 when:
- serum total or low-density lipoprotein (LDL) cholesterol concentration is not appropriately controlled (as defined in section 1.5) either after appropriate dose titration of initial statin therapy or because dose titration is limited by intolerance to the initial statin therapy (as defined in section 1.6)
- consideration is being given to changing from initial statin therapy to an alternative statin.
1.4 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.
1.5 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.
1.6 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.
The guidance shown above constitutes Section 1 of the full document. A copy of the full document and a summary of the evidence is available on the Internet at http://guidance.nice.org.uk/TA132
An abridged version of this guidance (a 'quick reference guide') is also available. Printed copies of the quick reference guide can be obtained by contacting 0845 003 7783 or emailing email@example.com and quoting reference number N1402. It is also available on the Internet at http://www.nice.org.uk/guidance/index.jsp?action=download&o=38399
This guidance represents the view of the Institute which was arrived at after careful consideration of the available evidence. Health professionals are expected to fully take it into account when exercising their clinical judgement. This guidance does not, however, override the individual responsibility of health professionals to make appropriate decisions in the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.
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Enquiries concerning the guidance should be addressed to: National Institute for Health and Care Excellence, MidCity Place, 71 High Holborn, London WC1V 6NA. email: firstname.lastname@example.org
Ezetimibe for the Treatment of Primary (Heterozygous Familial and Non-Familial) Hypercholesterolaemia
Issue Date: November 2007
Review Date: August 2010