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Lipid management
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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:
– 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 therapy
NICE 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 therapy
NICE 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 that this 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
Primary Secondary
prevention prevention
Anion exchange Consider if not able Consider if not able
resin to tolerate statins to tolerate statins
Fibrate Consider if not able Consider if not able
to tolerate statins to tolerate statins
Nicotinic acid Do not offer Consider if not able
to tolerate statins
• 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 compared
NICE CG 66 Type 2 diabetes, May 2008 and CG 67 lipids May 2008
CV risk assessment Type 2 diabetes
and lipids (CG 67) (CG66)
Patients without Simvastatin 40mg* Simvastatin 40mg,
established CVD but No lipid target increase to 80mg
>20% 10–year CVD unless TC <4mmol/L or
risk LDL <2mmol/L
Patients with Simvastatin 40mg*, Simvastatin 40mg,
established CVD (no consider increasing to consider intensifying
ACS) or increased simvastatin 80mg if TC with a „more effective‟
albumin excretion rate is not <4mmol/L or LDL statin or ezetimibe▼ to
(type 2 diabetes) is not <2mmol/L achieve TC <4mmol/L
or LDL <2mmol/L
*Or alternative in certain circumstances – see guidance
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Three steps to lipid heaven
1. 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
2. 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
3. Support patients in continuing to take their treatment
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