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ESC Clinical Practice Guidelines 2016
Highlights: Dyslipidaemias
Martine Gilard and Alberto Cordero Brest University Alicante University
France Spain
ESC CP Guidelines 2016 – Highlights: Dyslipidaemias
• Maintain global CV risk assessment by the SCORE
• Moderate renal dysfunction re-classification
• Keep treatment targets
• Proposal of a treatment scheme
• New recommendation for non-statin treatments and drug combinations
• Recommendations for PCSK-9 inhibitors
ESC CP Guidelines 2016 – Highlights: Dyslipidaemias Lipid determinations and treatment targets
2016 ESC Dyslipidaemias guidelines 2011 ESC Dyslipidaemias guidelines
Recommendation Class Level
LDL-C is the primary target for treatment
I A
TC should be considered as a treatment target if other are not available
IIa A
Non-HDL-C should be considered as a secondary treatment target
IIa B
ApoB should be considered as a secondary treatment target only if available
IIa B
HDL-C is not recommended as a target for treatment
III A
ApoB/ApoAI or non-HDL-C/HDL-C ratios are not recommended treatment targets
III B
Recommendation Class Level
LDL-C is the primary target for treatment
I A
TC should be considered as a treatment target if other are not available
IIa A
Non-HDL-C should be considered as a secondary treatment target in combined DLP, DM, MS and CKD
IIa B
ApoB should be considered as a secondary treatment target
IIa B
HDL-C is not recommended as a target for treatment
III A
ApoB/ApoAI or non-HDL-C/HDL-C ratios are not recommended treatment targets
III B
ESC CP Guidelines 2016 – Highlights: Dyslipidaemias Lipoprotein (a)
2016 ESC Dyslipidaemias guidelines 2011 ESC Dyslipidaemias guidelines
Recommendations:
- Not recommended for risk screening in the general population - Lp(a) measurement should be considered in:
1. People with high CVD risk 2. Strong family history of premature
atherothrombotic disease
Recommendations:
- Not recommended for risk screening in the general population - Individuals considered for screening:
1. Premature CVD 2. Familial hypercholesterolaemia 3. Family history of premature CVD
and/or elevated Lp(a) 4. Recurrent CVD despite optimal lipid
lowering treatment 5. ≥5% 10-year risk of fatal CVD according
to SCORE
ESC CP Guidelines 2016 – Highlights: Dyslipidaemias CV risk categories
2016 ESC Dyslipidaemias guidelines 2011 ESC Dyslipidaemias guidelines
Recommendation
VERY-HIGH CV risk: - Documented CVD - DM or type-1 DM with TOG - GFR <60 mg/ml/1.72 m2
- 10 year risk SCORE ≥10%
HIGH CV risk: - Markedly elevated single risk factor - 10 year risk SCORE ≥5% and <10%
MODERATE CV risk: - 10 year risk SCORE ≥1% and <5%
LOW CV risk: - 10 year risk SCORE <1%
Recommendation
VERY-HIGH CV risk: - Documented CVD - DM or type-1 DM with TOG - Severe RD: GFR <30 mg/ml/1.73 m2
- 10 year risk SCORE ≥10%
HIGH CV risk: - Markedly elevated single risk factor - 10 year risk SCORE ≥5% and <10% - Moderate RD: GFR 30-59 mg/ml/1.73 m2
MODERATE CV risk: - 10 year risk SCORE ≥1% and <5%
LOW CV risk: - 10 year risk SCORE <1%
ESC CP Guidelines 2016 – Highlights: Dyslipidaemias Treatment targets
2016 ESC Dyslipidaemias guidelines 2011 ESC Dyslipidaemias guidelines
Recommendation Class Level
VERY-HIGH CV risk: LDL-c goal <70 mg/dl (1.8 mmol/L) and/or 50% reduction when target cannot be reached
I A
HIGH CV risk: LDL-c goal <100 mg/l (2.5 mmol/L)
IIa A
MODERATE CV risk: LDL-c goal <115 mg/dl (3.0 mmol/L)
IIa C
Recommendation Class Level
VERY-HIGH CV risk: LDL-c goal <70 mg/dl (1.8 mmol/L) and/or 50% reduction if baseline is 70-135 mg/dl (1.8-3.5 mmol/L)
I B
HIGH CV risk: LDL-c goal <100 mg/l (2.6 mmol/L) or 50% reduction if baseline is 100-200 mg/dl (2.6-5.1 mmol/L)
I B
MODERATE CV risk: LDL-c goal <115 mg/dl (3.0 mmol/L)
IIa C
ESC CP Guidelines 2016 – Highlights: Dyslipidaemias Treatment targets
2016 ESC Dyslipidaemias guidelines 2011 ESC Dyslipidaemias guidelines
Recommendation Class Level
VERY-HIGH CV risk: LDL-c goal <70 mg/dl (1.8 mmol/L) and/or 50% reduction when target cannot be reached
I A
HIGH CV risk: LDL-c goal <100 mg/l (2.5 mmol/L)
IIa A
MODERATE CV risk: LDL-c goal <115 mg/dl (3.0 mmol/L)
IIa C
Recommendation Class Level
VERY-HIGH CV risk: LDL-c goal <70 mg/dl (1.8 mmol/L) and/or 50% reduction if baseline is 70-135 mg/dl (1.8-3.5 mmol/L)
I B
HIGH CV risk: LDL-c goal <100 mg/l (2.6 mmol/L) or 50% reduction if baseline is 100-200 mg/dl (2.6-5.1 mmol/L)
I B
MODERATE CV risk: LDL-c goal <115 mg/dl (3.0 mmol/L)
IIa C
ESC CP Guidelines 2016 – Highlights: Dyslipidaemias Treatment scheme
1. Evaluate the total CV risk of the subject
2. Involve the patient with decisions on CV risk management
3. Identify the LDL-C goal for that risk level
4. Calculate the % of LDL-C reduction required to achieve that goal
5. Choose a statin and a dose that could provide this reduction
6. Response to statin treatment is variable, therefore up-titration
of the dose may be required
7. If the highest tolerated statin dose does not reach the goal,
consider drug combinations
8. In addition, a reduction ≥ 50% in LDL-C should be achieved in
very high and high risk patients
2016 ESC Dyslipidaemias guidelines
ESC CP Guidelines 2016 – Highlights: Dyslipidaemias Treatment scheme
1. Evaluate the total CV risk of the subject
2. Involve the patient with decisions on CV risk management
3. Identify the LDL-C goal for that risk level
4. Calculate the % of LDL-C reduction required to achieve that goal
5. Choose a statin and a dose that could provide this reduction
6. Response to statin treatment is variable, therefore up-titration
of the dose may be required
7. If the highest tolerated statin dose does not reach the goal,
consider drug combinations
8. In addition, a reduction ≥ 50% in LDL-C should be achieved in
very high and high risk patients
2016 ESC Dyslipidaemias guidelines
ESC CP Guidelines 2016 – Highlights: Dyslipidaemias Treatment scheme
1. Evaluate the total CV risk of the subject
2. Involve the patient with decisions on CV risk management
3. Identify the LDL-C goal for that risk level
4. Calculate the % of LDL-C reduction required to achieve that goal
5. Choose a statin and a dose that could provide this reduction
6. Response to statin treatment is variable, therefore up-titration
of the dose may be required
7. If the highest tolerated statin dose does not reach the goal,
consider drug combinations
8. In addition, a reduction ≥ 50% in LDL-C should be achieved in
very high and high risk patients
2016 ESC Dyslipidaemias guidelines
ESC CP Guidelines 2016 – Highlights: Dyslipidaemias Treatment scheme
1. Evaluate the total CV risk of the subject
2. Involve the patient with decisions on CV risk management
3. Identify the LDL-C goal for that risk level
4. Calculate the % of LDL-C reduction required to achieve that goal
5. Choose a statin and a dose that could provide this reduction
6. Response to statin treatment is variable, therefore up-titration
of the dose may be required
7. If the highest tolerated statin dose does not reach the goal,
consider drug combinations
8. In addition, a reduction ≥ 50% in LDL-C should be achieved in
very high and high risk patients
2016 ESC Dyslipidaemias guidelines
ESC CP Guidelines 2016 – Highlights: Dyslipidaemias Drug combinations
2016 ESC Dyslipidaemias guidelines 2011 ESC Dyslipidaemias guidelines
Recommendation: Class Level
Prescribe statin up to the highest recommended dose or highest tolerable dose to reach the goal
I A
Recommendation: Class Level
Prescribe statin up to the highest recommended dose or highest tolerable dose to reach the goal
I A
ESC CP Guidelines 2016 – Highlights: Dyslipidaemias Drug combinations
2016 ESC Dyslipidaemias guidelines 2011 ESC Dyslipidaemias guidelines
Recommendation Class Level
If statin intolerance, ezetimibe or bile acid sequestrants, or these combined, should be considered
IIa C
If goal is not reached, statin combination with a cholesterol absorption inhibitor should be considered
IIa B
Statin combination with a bile acid sequestrant may be considered
IIb B
Recommendation Class Level
If statin intolerance, ezetimibe or bile acid sequestrants, or these combined, should be considered
IIa C
If goal is not reached, statin combination with a cholesterol absorption inhibitor, bile sequetran acid or nicotinic acid should be considered
IIb B
ESC CP Guidelines 2016 – Highlights: Dyslipidaemias Drug combinations
2016 ESC Dyslipidaemias guidelines 2011 ESC Dyslipidaemias guidelines
Recommendation Class Level
If goal is not reached, statin combination with a cholesterol absorption inhibitor should be considered
IIa B
Statin combination with a bile acid sequestrant may be considered
IIb B
Recommendation Class Level
If goal is not reached, statin combination with a cholesterol absorption inhibitor, bile sequetran acid or nicotinic acid should be considered
IIb B
ESC CP Guidelines 2016 – Highlights: Dyslipidaemias Drug combinations
2016 ESC Dyslipidaemias guidelines
Recommendation Class Level
Very high risk patients, with persistent high LDL-C despite treatment with maximal statin dose, in combination with ezetimibe or in patients with statin a PCSK9 inhibitor may be considered
IIb C
ESC CP Guidelines 2016 – Highlights: Dyslipidaemias Statin intolerants
2016 ESC Dyslipidaemias guidelines
ESC CP Guidelines 2016 – Highlights: Dyslipidaemias Treatment of tryglicerides
2016 ESC Dyslipidaemias guidelines 2011 ESC Dyslipidaemias guidelines
Recommendation Class Level
Treatment considered in high risk patients and TG >2.3 mmol/L (200 mg/dl)
IIa B
Statins considered as the first drug of choice for reducing CVD risk in high risk individuals with hypertriglyceridaemia
I A
In high risk patients with TG >2.3 mmol/L despite treated with statin, fenofibrate considered in combination with statins
IIb C
Recommendation Class Level
Fibrates drug of choice I B
Considerd nicotinic acid IIa B
Nicotinic acid +laropiprant IIa C
Statin+Nicotinic acid IIa A
Statin+Fibrate IIa C
N-3 fatty acids IIa B
Fibrate+n-3 fatty acids IIb B
ESC CP Guidelines 2016 – Highlights: Dyslipidaemias Treatment of HDL
2016 ESC Dyslipidaemias guidelines 2011 ESC Dyslipidaemias guidelines
Recommendation Class Level
Statins and fibrates raise HDL-C with similar magnitude and these drugs may be considered
IIb B
The efficacy of fibrates to increase HDL-C may be attenuated in people with type 2 diabetes
IIb B
Recommendation Class Level
Nicotinc acid is the most efficent drug to raise HDL-C and should be considered
IIa A
Statins and fibrates raise HDL-C with similar magnitude and these drugs may be considered
IIb B
The efificacy of fibrates to increase HDL-c may be attenuated in people with type 2 diabetes
IIb B
ESC CP Guidelines 2016 – Highlights: Dyslipidaemias Familial hypercholesterolemia
2016 ESC Dyslipidaemias guidelines
• Clinical diagnosis and screening by the Dutch Lipid Clinic Network diagnostic criteria
• Genetic cascade screening of family members
• Cholesterol lowering treatment should be initiated as soon as possible
PCSK9 antibodies have recently been registered for use in FH patients. • Efficiently lower LDL-C by up to 60% on top of the statin. • There are no randomized controlled studies with clinical endpoints and therefore the use
of the drugs still should be restricted. • May be considered in patients with FH:
1. Very high risk due to the presence of CVD 2. Family history of CAD at very young age 3. LDL-C level far from goal even on maximal other therapy 4. FH patients who cannot tolerate statins 5. FH patients with high Lp(a).
ESC CP Guidelines 2016 – Highlights: Dyslipidaemias The elderly
2016 ESC Dyslipidaemias guidelines 2011 ESC Dyslipidaemias guidelines
Recommendation Class Level
Treatment with statins is recommended for older adults with established CVD in the same way as for younger patients
I A
Lipid-lowering medication should be started at a lower dose and then titrated to targets
IIa C
Statin therapy should be considered in older adults free from CVD, in the presence of HT, smoking, DM or dyslipidaemia.
IIa B
Recommendation Class Level
Treatment with statins is recommended for older adults with established CVD in the same way as for younger patients
I B
Lipid-lowering medication should be started at a lower dose and then titrated to targets
I C
Statin therapy should be considered in older adults free from CVD, in the presence of HT, smoking, DM or dyslipidaemia.
IIb B
ESC CP Guidelines 2016 – Highlights: Dyslipidaemias ACS patients or PCI
2016 ESC Dyslipidaemias guidelines
Recommendation Class Level
Initiate or continue high dose statins early after admission in all ACS patients without contraind. or intolerance, regardless of initial LDL-C values
I A
If LDL-C target is not reached, with the highest tolerable statin dose, ezetimibe should be considered in combination with statins in post-ACS.
IIa B
If LDL target is not reached with the highest tolerable statin dose and/or ezetimibe, PCSK9 inhibitors may be considered on top of lipid-lowering therapy; or alone or in combination with ezetimibe in statin intolerant patients or in whom a statin is contraindicated
IIb C
Lipids should be re-evaluated 4–6 weeks after the ACS to assess LDL-C target (70 mg/dL or a reduction of at least 50% and whether there are any safety issues; the therapy dose should then be adapted accordingly.
IIa C
Routine short pretreatment or loading with high-dose statin before PCI should be considered in elective PCI or in NSTE-ACS.
IIa A