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Lipid management. Primary prevention: Risk assessment NICE CG 67: Lipid modification May 2008. Offer information about: Absolute risk of Cardiovascular disease (CVD) Absolute benefits/harms of an intervention over a 10-year period Information should:

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Primary prevention risk assessment nice cg 67 lipid modification may 2008 l.jpg
Primary prevention: Risk assessmentNICE CG 67: Lipid modification May 2008

Offer information about:

Absolute risk of Cardiovascular disease (CVD)

Absolute benefits/harms of an intervention over a 10-year period

Information should:

Present individualised risk/benefit scenarios

Present absolute risk of events numerically

Use appropriate diagrams and text

See patient decision aids on lipids floor of NPCi


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Primary prevention: Statin therapyNICE CG 67: Lipid modification May 2008

  • Offer statin therapy for adults who have a 20% or greater 10-year risk of developing CVD

    • Use a risk calculator or clinical judgement if a risk calculator is not available or appropriate

  • Decision to treat should follow an informed discussion about risks and benefits

  • Initiate treatment with simvastatin 40mg

    • If simvastatin 40mg is contraindicated, offer a lower dose or alternative preparation (such as pravastatin)

    • Higher–intensity statins should not be used routinely

  • A target for total or low–density lipoprotein (LDL) cholesterol is not recommended


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Secondary prevention: Statin therapyNICE CG 67: Lipid modification May 2008

  • Offer statin therapy to all patients with established CVD

    • Do not delay to manage modifiable risk factors

    • Treat co morbidities and secondary causes of dyslipidaemia

  • Decision to treat should follow an informed discussion about risks and benefits

  • Initiate treatment with simvastatin 40mg

    • offer patients with acute coronary syndrome (ACS) a higher–intensity statin (see later)

    • if simvastatin 40mg is contraindicated, offer a lower dose or alternative preparation (such as pravastatin)


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Secondary prevention (non-ACS): High doses and targets (1)NICE CG 67: Lipid modification May 2008

  • ‘Consider increasing to simvastatin 80mg or a drug of similar efficacy and acquisition cost if a total cholesterol of less than 4 mmol/litre or an LDL cholesterol of less than 2 mmol/litre is not attained’

  • ‘Any decision to offer a higher intensity statin should take into account the patients informed preference, co morbidities, multiple drug therapy, and the benefits and risks of treatment’

    • Note: a single cholesterol level reading may well under - or over estimate a patient’s true average cholesterol level by up to 14%

    • See also next slide


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Secondary prevention (non-ACS):High doses and targets (2)NICE full guideline May 2008

  • ‘The use of a target figure can be helpful in guiding increases of lipid lowering drugs as long as it is clear thatthis figure is intended to guide treatment rather than be a figure patients are expected to achieve’

  • ‘An ‘audit’ level of total cholesterol of 5mmol/litre should be used to assess progress in populations or groups of people with CVD’

  • ‘The result of modelling suggest that titration using a threshold target of 4mmol/l total cholesterol is cost-effective so long as titration stops at simvastatin 80mg’

  • ‘Most patients would not achieve a target of 4mmol/l total cholesterol and modelling suggests that it is not cost-effective to try to take more patients to target using higher cost statins such as atorvastatin’


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What about patients with ACS?NICE full guideline May 2008

  • People with acute coronary syndrome should be treated with a higher–intensity statin

  • “Any decision to offer a higher intensity statin should take into account the patient's informed preference, co morbidities, multiple drug therapy, and the benefits and risks of treatment”

  • Atorvastatin 80mg and simvastatin 80mg are both cost– effective in ACS

  • No lipid target specified

  • For how long should patients with ACS take higher–intensity statins?


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What about ezetimibe▼? (1)NICE TA 132 November 2007 (& NICE TA 094 January 2006)

  • Ezetimibe▼ monotherapy is an option for adults with primary (heterozygous-familial or non-familial) hypercholesterolaemia (at 20% or greater 10–year CVD risk) in whom statins are contraindicated or not tolerated

  • Ezetimibe▼, co-administered with initial statin therapy, is an option for patients with primary hypercholesterolaemia taking statins when:

    • TC or LDL ‘is not appropriately controlled’ either after dose titration of initial statin therapy or because dose titration is limited by intolerance to the statin therapy

    • and

    • Consideration is being given to changing from initial statin therapy to an alternative statin


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What about ezetimibe▼? (2)

  • But

  • Although ezetimibe▼ effectively lowers LDL levels,there is currently no published evidence that ezetimibe▼ alone or added to a statin helps patients live longer or live better

    • ENHANCE study (January 2008): no significant difference in carotid intima-media thickness with ezetimibe▼versus placebo, added to simvastatin 80mg, in familial hypercholesterolaemia

    • SEAS study (September 2008): no significant difference in major CV events with ezetimibe▼+ simvastatin 40mg, versus placebo in patients with aortic stenosis. Hazard Ratio (HR) for new cancer 1.55, P=0.01


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What about other alternatives?NICE CG 67: Lipid modification May 2008

The combination of an anion exchange resin, fibrate or nicotinic acid with a statin should not be offered for primary prevention of CVD

The combination of a fish oil supplement with a statin should not be offered for primary prevention of CVD


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NICE guidance comparedNICE CG 66 Type 2 diabetes, May 2008 and CG 67 lipids May 2008

*Or alternative in certain circumstances – see guidance


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Three steps to lipid heaven

Make sure you understand, and can explain to patients, the likely absolute benefits and risks of treatment

See the decision aid on this floor of NPCi, and the information mastery skills floor

Use an evidence-based dose of an evidence-based drug and don’t chase targets

Simvastatin 40mg is first choice drug and dose for most people (note exceptions e.g. interactions, patients with ACS, etc. and NICE guidance on when to consider increasing)

Lipid levels in NICE are a guide to treatment not targets patients are expected to achieve

Don’t adjust treatment on basis of single measurements

Note differences in type 2 diabetes guidance

Only (POO) data for ezetimibe▼ are negative

Support patients in continuing to take their treatment