Ezetimibe for the Treatment of Primary Heterozygous Familial and Non-Familial Hypercholesterolaemia (TA385)

Technology Appraisal Guidance No. 385

Source: National Institute for Health and Care Excellence

NOTE: This guidance replaces NICE technology appraisal guidance 132

1. Guidance

1.1 This guidance should be used with NICE's guidelines on cardiovascular disease: risk assessment and reduction, including lipid modification and familial hypercholesterolaemia: identification and management.

1.2 Ezetimibe monotherapy is recommended as an option for treating primary (heterozygous-familial or non-familial) hypercholesterolaemia in adults in whom initial statin therapy is contraindicated.

1.3 Ezetimibe monotherapy is recommended as an option for treating primary (heterozygous-familial or non-familial) hypercholesterolaemia in adults who cannot tolerate statin therapy (as defined in section 1.6).

1.4 Ezetimibe, co-administered with initial statin therapy, is recommended as an option for treating primary (heterozygous-familial or non-familial) hypercholesterolaemia in adults who have started statin therapy when:

  • serum total or low-density lipoprotein (LDL) cholesterol concentration is not appropriately controlled (as defined in section 1.7) 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) and
  • a change from initial statin therapy to an alternative statin is being considered.

1.5 When prescribing ezetimibe co-administered with a statin, ezetimibe should be prescribed on the basis of lowest acquisition cost.

1.6 For the purposes of this guidance, intolerance to initial statin therapy is defined as the presence of clinically significant adverse effects that represent an unacceptable risk to the patient or that may reduce compliance with therapy.

1.7 For the purposes of this guidance, appropriate control of cholesterol concentrations should be based on individual risk assessment according to national guidance on managing cardiovascular disease in the relevant populations.


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/TA385

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.

© Copyright National Institute for Health and Care Excellence. All rights reserved. This material may be freely reproduced for educational and not for profit purposes within the NHS. No reproduction by or for commercial organisations is permitted without the express written permission of the Institute.

Enquiries concerning the guidance should be addressed to: National Institute for Health and Care Excellence, MidCity Place, 71 High Holborn, London WC1V 6NA. email: nice@nice.org.uk

Ezetimibe for treating primary heterozygous familial and non-familial hypercholesterolaemia

Issue Date: February 2016


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