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1、Issue date: November 2007Review date: August 2010NICE technology appraisal guidance 132Ezetimibe for the treatment of primary (heterozygous-familial and non-familial) hypercholesterolaemiaNICE technology appraisal guidance 132NICE technology appraisal guidance 132 Ezetimibe for the treatment of prim
2、ary (heterozygous-familial and non-familial) hypercholesterolaemiaOrdering informationYou can download the following documents from www.nice.org.uk/TA132 The full guidance (this document). A quick reference guide for healthcare professionals. Information for people with primary (heterozygous-familia
3、l and non-familial) hypercholesterolaemia and their carers (Understanding NICE guidance). Details of all the evidence that was looked at and other background information.For printed copies of the quick reference guide or Understanding NICE guidance, phone the NHS Response Line on 08701555455 and quo
4、te: N1402 (quick reference guide) N1403 (Understanding NICE guidance).This guidance is written in the following contextThis guidance represents the view of the Institute, which was arrived at after careful consideration of the evidence available. Healthcare professionals are expected to take it full
5、y into account when exercising their clinical judgement. The guidance does not, however, override the individual responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.National
6、 Institute for Health and Clinical ExcellenceMidCity Place71 High HolbornLondon WC1V 6NAwww.nice.org.uk National Institute for Health and Clinical Excellence, 2007. All rights reserved. This material may be freely reproduced for educational and not-for-profit purposes. No reproduction by or for comm
7、ercial organisations, or for commercial purposes, is allowed without the express written permission of the Institute. Contents 1Guidance12Clinical need and practice23The technology44Evidence and interpretation65Implementation206Recommendations for further research217Related NICE guidance218Date for
8、review of guidance22Appendix A. Appraisal Committee members and NICE project team23Appendix B. Sources of evidence considered by the Committee28NICE technology appraisal guidance 1321 GuidanceThis guidance should be read in conjunction with NICE guidance on the initiation of statin therapy (NICE tec
9、hnology 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 follow
10、ing 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 adult
11、s 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 Ezetim
12、ibe monotherapy is recommended as an option for the treatment of adults with primary (heterozygous-familial or non-familial) hypercholesterolaemia who are intolerant tostatin therapy (as defined in section 1.6).1.3 Ezetimibe, coadministered with initial statin therapy, is recommended as an option fo
13、r the treatment of adults with primary (heterozygous-familial or non-familial) hypercholesterolaemia who have been initiated on statin therapy (as per NICE guidance TA94 in adults with non-familial hypercholesterolaemia) when: serum total or low-density lipoprotein (LDL) cholesterol concentration is
14、 not appropriately controlled (as defined in section1.5) 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 section1.6)and consideration is being given to changing from initial statin ther
15、apy 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 in
16、dividualised 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 st
17、atin 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), sign
18、ificant gastrointestinal disturbance or alterations of liver function tests. 2 Clinical need and practice2.1 Hypercholesterolaemia is defined as the presence of high concentrations of cholesterol in the blood. Primary hypercholesterolaemia is associated with an underlying genetic cause; this may be
19、a specific genetic defect, as in the autosomal dominant disorder familial hypercholesterolaemia (FH). In heterozygous-familial hypercholesterolaemia (He-FH) one of the pair of low-density lipoprotein (LDL) cholesterol receptor genes is defective or mutated and impairs the LDL cholesterol receptor ac
20、tivity. The result being that LDL cholesterol levels are markedly elevated, with other forms of cholesterol remaining normal. Non-familial hypercholesterolaemia is the more common form of primary hypercholesterolaemia where a number of genes interact with dietary and other factors such as smoking an
21、d physical inactivity. 2.2 Individuals with hypercholesterolaemia are at increased risk of cardiovascular disease (CVD) because long-term elevations of cholesterol accelerate the build up of fatty deposits in the arteries, a process known as atherosclerosis. The narrowing of the arteries can cause c
22、ardiovascular problems such as angina (pain or discomfort in the chest or neighbouring parts of the body because of insufficient oxygen reaching the heart), myocardial infarction (MI heart attack) and stroke. CVD is the most common cause of death in the UK, accounting for approximately 216,000 death
23、s in 2004, and it is a major cause of illness, disability and reduced quality of life. 2.3 People with FH have marked elevations in cholesterol and are at particular risk of developing premature CVD. For example, untreated people with HeFH are likely to develop cardiovascular symptoms by the fourth
24、or fifth decade of life. HeFH affects around 1 in every 500 adults in Europe.2.4 Total cholesterol concentration is comprised of LDL cholesterol, high-density lipoprotein HDL cholesterol and triglycerides (TGs).The increased risk of CVD in people with hypercholesterolaemia is highly correlated with
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