The ESC/EAS Guidelines

www.escardio.org/guidelines
The ESC/EAS Guidelines
for the Management of Dyslipidaemias
and the AHA/ACC Guidelines
Alberico L. Catapano

www.escardio.org/guidelines European Heart Journal (2011) 32, 1769–1818
SCORE chart: 10 year risk of fatal cardiovascular
disease (CVD) in populations at low CVD risk
15% and over
10%-14%
5%-9%
3%-4%
2%
1%
< 1%
SCORE
10-year risk of
fatal CVD in
populations at
Low CVD risk
Non-smoker Smoker
180
160
140
120 3
4
6
9
3
4
6
9
3
5
7
11
4
6
8
12
4
7
10
14
1
2
3
4
1
2
3
5
2
2
4
6
2
3
4
6
2
3
5
7
180
160
140
120 1
2
3
5
2
2
4
5
2
3
4
6
2
3
5
7
3
4
5
8
1
1
2
3
1
1
2
3
1
1
2
3
1
2
2
4
1
2
3
4
180
160
140
120 1
1
2
3
1
1
2
3
1
1
2
3
1
2
3
4
1
2
3
4
0
1
1
1
0
1
1
1
1
1
1
2
1
1
1
2
1
1
1
2
180
160
140
120 0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
180
160
140
120 0
1
1
1
0
1
1
1
0
1
1
2
1
1
1
2
1
1
1
2
0
0
0
1
0
0
0
1
0
0
1
1
0
0
1
1
0
0
1
1
4 5 6 7 8 4 5 6 7 8
Women
Systolicbloodpressure(mmHg)
Cholesterol (mmol/L)
Age
65
60
55
50
40
Non-smoker Smoker
Men
5
7
10
15
5
8
12
17
6
9
14
20
8
11
16
23
9
13
19
26
2
4
5
8
3
4
6
9
3
5
7
10
4
6
8
12
5
7
10
14
3
5
7
10
4
5
8
11
4
6
9
13
5
7
11
15
6
9
13
18
2
2
3
5
2
3
4
6
2
3
5
7
3
4
5
8
3
4
6
9
2
3
4
6
2
3
5
7
3
4
6
8
3
5
7
10
4
6
8
12
1
1
2
3
1
2
2
4
1
2
3
4
2
2
3
5
2
3
4
6
0
0
1
1
0
1
1
1
0
1
1
1
1
1
1
2
1
1
1
2
0
0
0
0
0
0
0
1
0
0
0
1
0
0
1
1
0
0
1
1
1
2
2
4
1
2
3
4
2
2
3
5
2
3
4
6
2
3
5
7
1
1
1
2
1
1
1
2
1
1
2
3
1
1
2
3
1
2
2
4
4 5 6 7 8 4 5 6 7 8
150 200250300
mg/dl

Relative risk chart
European Heart Journal (2011) 32, 1769–1818
● This chart may be used to show younger people at low absolute risk that, relative to
others in their age group, their risk may be many times higher than necessary. This
may help to motivate decisions about avoidance of smoking, healthy nutrition and
exercise, as well as flagging those who may become candidates for medication.
Please note that this chart shows RELATIVE not absolute risk. The risks are RELATIVE to 1 in the bottom left.
Thus a person in the top right hand box has a risk that is 12 times higher than a person in the bottom left.
Non-smoker
180
160
140
120 2
3
4
6
2
3
5
7
3
4
6
8
3
5
7
10
4
6
8
12
1
1
2
3
1
2
3
3
1
2
3
4
2
2
4
5
2
3
4
6
4 5 6 7 8
Smoker
4 5 6 7 8
Cholesterol (mmol/L)
Systolic blood
pressure (mmHg)

Risk function without high-density lipoprotein-cholesterol (HDL-C)
for women in populations at high cardiovascular disease risk
Non-smoker Smoker
180
160
140
120 0
0
0
0
0
0
0
0
0
0
0
1
0
0
0
1
0
0
0
1
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
180
160
140
120 1
1
1
1
1
1
1
2
1
1
1
2
1
1
1
2
1
1
2
2
0
0
1
1
0
0
1
1
0
1
1
1
0
1
1
1
0
1
1
1
4 5 6 7 8 4 5 6 7 8
Total Cholesterol (mmol/L)
1
1
1
2
1
1
1
2
1
1
2
2
1
1
2
1
1
2
22
1
2
2
3
1
2
3
3
2
2
3
4
2
2
3
2
2
3
44
3
4
5
7
3
5
7
3
4
6
8
4
5
6
8
4
5
7
9
4 8
10
14
6
8
11
14
7
9
12
15
7
9
12
16
8
10
13
17
6
3
4
5
6
3
4
5
7
3
4
5
7
3
6
8
4
5
6
8
4
2
2
3
4
2
2
3
4
2
2
3
4
2
2
3
2
3
4
54
Age
65
60
55
50
40
180
160
140
120
180
160
140
120
180
160
140
120
Without HDL
HDL 0.8
HDL 1.0
HDL 1.4
HDL 1.8
5.7
10.2
8.5
5.9
4.0
Without HDL
HDL 0.8
HDL 1.0
HDL 1.4
HDL 1.8
4.4
8.5
7.0
4.7
3.2
Without HDL
HDL 0.8
HDL 1.0
HDL 1.4
HDL 1.8
4.5
8.3
6.9
4.7
3.2
Without HDL
HDL 0.8
HDL 1.0
HDL 1.4
HDL 1.8
2.1
4.4
3.5
2.3
1.5
Without HDL
HDL 0.8
HDL 1.0
HDL 1.4
HDL 1.8
4.4
8.1
6.7
4.5
3.0
Without HDL
HDL 0.8
HDL 1.0
HDL 1.4
HDL 1.8
4.2
8.0
6.5
4.4
2.9
Without HDL
HDL 0.8
HDL 1.0
HDL 1.4
HDL 1.8
2.4
4.6
3.8
2.5
1.7
Systolic blood pressure (mmHg)

Qualifiers
● The charts can assist in risk assessment and management but must be
interpreted in the light of the clinician’s knowledge and experience and
of the patient’s pre-test likelihood of CVD.
● Risk will be overestimated in countries with a falling CVD mortality, and
underestimated in countries in which mortality is increasing.
● At any given age, risk estimates are lower for women than for men. This may
be misleading since, eventually, at least as many women as men die of CVD.
Inspection of the charts indicates that risk is merely deferred in women, with
a 60-year-old woman resembling a 50-year-old man in terms of risk.

Risk will also be higher than indicated
in the charts in:
● Socially deprived individuals; deprivation drives many other risk factors.
● Sedentary subjects and those with central obesity; these characteristics determine many of the other
aspects of risk listed below.
● Individuals with diabetes: re-analysis of the SCORE database indicates that those with known
diabetes are at greatly increased risk; ﬁve times higher in women and three times higher in men.
● Individuals with low HDL-C or apolipoprotein A1 (apo A1), increased TG, ﬁbrinogen, homocysteine,
apolipoprotein B (apo B), and lipoprotein(a) [Lp(a)] levels, familial hypercholesterolaemia (FH),
or increased hs-CRP; these factors indicate a higher level of risk in both genders, all age groups
and at all levels of risk. As mentioned above, supplementary material (see Addendum I) illustrates
the additional impact of HDL-C on risk estimation.
● Asymptomatic individuals with preclinical evidence of atherosclerosis, for example, the presence
of plaques or increased carotid intima-media thickness (CIMT) on carotid ultrasonography.
● Those with impaired renal function.
● Those with a family history of premature CVD, which is considered to increase the risk by 1.7-fold in
women and by 2.0-fold in men.
● Conversely, risk may be lower than indicated in those with very high HDL-C levels or a family history
of longevity.

Intervention strategies as a function
of total CV risk and LDL-C level
Total CV risk
(SCORE)
%
LDL-C levels
< 70 mg/dL
< 1.8 mmol/L
70 to < 100 mg/dL
1.8 to < 2.5 mmol/L
100 to < 155 mg/dL
2.5 to < 4.0 mmol/L
155 to < 190 mg/dL
4.0 to < 4.9 mmol/L
> 190 mg/dL
> 4.9 mmol/L
< 1 No lipid intervention No lipid intervention Lifestyle intervention Lifestyle intervention
Lifestyle intervention,
consider drug if
uncontrolled
Class/Level I/C I/C I/C I/C IIa/A
≥ 1 to < 5 Lifestyle intervention Lifestyle intervention
consider drug if
uncontrolled
consider drug if
uncontrolled
consider drug if
uncontrolled
Class/Level I/C I/C IIa/A IIa/A I/A
> 5 to < 10, or
high risk
Lifestyle intervention
consider drug*
consider drug*
and immediate drug
intervention
and immediate drug
intervention
and immediate drug
intervention
Class/Level IIa/A IIa/A IIa/A I/A I/A
≥ 10 or very
high risk
consider drug*
and immediate drug
intervention
and immediate drug
intervention
and immediate drug
intervention
and immediate drug
intervention
Class/Level IIa/A IIa/A I/A I/A I/A

Recommendations for treatment targets
for LDL-C
Recommendations Class Level
In patients at VERY HIGH CV risk (established CVD, type 2 diabetes, type 1
diabetes with target organ damage, moderate to severe CKD or a SCORE
level ≥ 10%) the LDL-C goal is < 1.8 mmol/L (less than ~ 70 mg/dL) and/or
≥ 50% LDL-C reduction when target level cannot be reached.
I A
In patients at HIGH CV risk (markedly elevated single risk factors, a SCORE
level ≥ 5 to < 10%) an LDL-C goal < 2.5 mmol/L (less than ~ 100 mg/dL)
should be considered.
IIa A
In subjects at MODERATE risk (SCORE level > 1 to ≤ 5%) an LDL-C goal
< 3.0 mmol/L (less than ~ 115 mg/dL) should be considered.
IIa C

To be preferred
To be used with
moderation
To be chosen occasionnaly
in limited amounts
Cereals Whole grains Refined bread, rice and pasta,
biscuits, corn flakes
Pastries, muffins, pies, croissants
Vegetables Raw and cooked vegetables
Vegetables prepared in butter or
cream
Legumes
All (including soy and soy
protein)
Fruit Fresh and frozen fruit Dried fruit, jelly, jam, canned
fruit, sorbets, popsicles
Sweets and
sweeteners
Non-caloric sweeteners Sucrose, honey, fructose,
glucose, chocolate, candies
Cake, ice creams
Meat and fish Lean and oil fish, poultry
without skin
Lean cuts of beef, lamb, pork
or veal, seafood, shellfish
Sausages, salami, bacon, spare
ribs, hot dogs, organ meats
Dairy food and eggs Skimmed milk and yogurt,
egg white
Low fat milk, low fat cheese
and other milk products
Regular cheese, cream, egg yolk,
whole milk and yoghurt
Cooking fat and
dressings
Vinegar, ketchup, mustard,
fat-free dressings
Vegetable oils, soft
margarines, salad dressing,
mayonnaise
Butter, solid margarines, trans fats,
palm and coconut oils; lard, bacon
fat, dressings made with egg yolks
Nuts/seeds All Coconut
Cooking procedures Grilling, boiling, steaming Stir-frying, roasting Frying
Dietary recommendations to lower
TC and LDL-C

Examples of causes of secondary
hypercholesterolaemia
● Hypothyroidism
● Nephrotic syndrome
● Pregnancy
● Cushing syndrome
● Anorexia nervosa
● Immunosuppressant agents
● Corticosteroids

Recommendations for the pharmacological
treatment of hypercholesterolaemia
Prescribe statin up to the highest recommended dose, or highest
tolerable dose to reach the target level.
I A
In the case of statin intolerance, bile acid sequestrants or nicotinic
acid should be considered.
IIa B
A cholesterol absorption inhibitor, alone or in combination with bile
acid sequestrants or nicotinic acid, may also be considered in the
case of statin intolerance.
IIb C
If target level is not reached, statin combination with a cholesterol
absorption inhibitor or bile acid sequestrant or nicotinic acid may be
considered.
IIb C

Recommendations for drug treatment of HTG
In particular high risk patients, lowering of HTG by using the following drugs:
is recommended:
fibrates
I B
should be considered:
nicotinic acid
IIa B
nicotinic acid + laropiprant IIa C
n-3 fatty acids IIa B
statin + nicotinic acid IIa A
statin + fibrate IIa C
may be considered:
combinations with n-3 fatty acids
IIb B

Recommendations if drug treatment
of low HDL-C is considered
Nicotinic acid is currently the most efficient 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 efficacy of fibrates to increase HDL-C may be attenuated in
people with type 2 diabetes.
IIb B

Diagnostic criteria for the clinical diagnosis
of HeFH according to MedPed and WHO
Criteria Score
Family history
First-degree relative known with premature CAD and/or
first-degree relative with LDL-C > 95th centile
1
First-degree relative with Tx and/or children < 18 with LDL-C
> 95th centile.
2
Clinical history
Patient has premature CAD 2
Patient has premature cerebral/peripheral vascular disease 1
Physical examination
Tx 6
Arcus cornealis below the age of 45 years 4
LDL-C
> 8.5 mmol/L (more than ~ 330 mg/dL) 8
6.5-8.4 mmol/L (~ 250-329 mg/dL) 5
5.0-6.4 mmol/L (~ 190-249 mg/dL) 3
4.0-4.9 mmol/L (~ 155-189 mg/dL) 1
Definite FH Score > 8
Probable FH Score 6-8
Possible FH Score 3-5
No diagnosis Score < 3

Recommendations for detection and
treatment of patients with HeFH
FH is suspected in patients with CVD aged < 50 years among men or < 60 years
among women, in subjects with relatives with premature CVD or in subjects with known
FH in the family.
I C
It is recommended to confirm the diagnosis with clinical criteria or whenever the
resources are available with DNA analysis.
I C
Family screening is indicated when a patient with HeFH is diagnosed; if resources are
available it is recommended to perform this as cascade screening.
I C
In HeFH high dose statin is recommended and whenever needed in combination with
cholesterol absorption inhibitors and/or a bile acid sequestrant.
I C
Children of parents with FH are recommended:
• to be diagnosed as early as possible,
• to be educated to adopt a proper diet,
• to receive pharmacological treatment in late childhood or in adolescence.
I C
Children with HoFH need special attention already from the first year of life. I C
Treatment is aimed at reaching the LDL-C goals for high risk subjects (< 2.5 mmol/L,
less than ~ 100 mg/dL) or in the presence of CVD of very high risk subjects
(< 1.8 mmol/L, less than ~ 70 mg/dL). If targets cannot be reached, maximal reduction
of LDL-C should be considered using appropriate drug combinations in tolerated doses.
IIa C

Genetic disorders of lipoprotein metabolism
Disorder Prevalence Gene(s) Effect on lipoproteins
HeFH I in 500
LDLR
PCSK9
APO B
 LDL
HoFH I in 106 LDLR  LDL
FCH I in 100/200 USFI + modifying genes
 LDL,  VLD
 APO B
Familial dysbetalipoproteinaemia I in 5000 APO E
 IDL and chylomicron
remnants (VLDL)
Familial lipoprotein lipase
deficiency
I in 106 LPL
APO C2
 chylomicrons
and VLDL
Tangier disease
(analphalipoproteinaemia)
I in 106 ABC-i  HDL
Familial LCAT deficiency
(fish eye disease)
I in 106 LCAT  HDL

Management of dyslipidaemia in women
● Statin treatment is recommended for primary prevention of CAD in
high risk women.
● Statins are recommended for secondary prevention in women with
the same indications and targets as in men.
● Lipid-lowering drugs should not be given when pregnancy is
planned, during pregnancy or during the breast feeding period.

Recommendations for treatment of
dyslipidaemia in the elderly
Treatment with statins is recommended for elderly patients with
established CVD in the same way as for younger patients.
I B
Since elderly people often have comorbidities and have altered
pharmacokinetics, it is recommended to start lipid-lowering
medication at a low dose and then titrate with caution to achieve
target lipid levels which are the same as in the younger subjects.
I C
Statin therapy may be considered in elderly subjects free of CVD,
particularly in the presence of at least one other CV risk factor
besides age.
IIb B

Summary of dyslipidaemia in MetS
and in type 2 diabetes
● Dyslipidaemia in MetS represents a cluster of lipid and lipoprotein
abnormalities including elevation of both fasting and postprandial
TGs, apo B, and small dense LDL, and low HDL-C and apo A 1.
● Non-HDL-C or apo B are good surrogate markers of TRLs and
remnants and are a secondary objective of theramy.
Non-HDL-C < 3.3 mmol/L (less than ~ 130 mg/dL) or apo B
< 100 mg/dL is desirable.
● Increased waist circumference and elevation of TGs seems to be
a simple tool to capture the high risk subjects with MetS.
● Atherogenic dyslipidaemia is one of the major risk factors for CVD
in people with type 2 diabetes.

Recommendations for treatment of
dyslipidaemia in diabetes
In all patients with type 1 diabetes and in the presence of
microalbuminuria and renal disease, LDL-C lowering (at least 30%)
with statins as the first choice (eventually drug combination) is
recommended irrespective of the basal LDL-C concentration.
I C
In patients with type 2 diabetes and CVD or CKD, and in those
without CVD who are over the age of 40 years with one or more
other CVD risk factors or markers of target organ damage, the
recommended goal for LDL-C is < 1.8 mmol/L (less than ~ 70 mg/dL)
and the secondary goal for non-HDL-C is < 2.6 mmol/L (100 mg/dL)
and for apo B is < 80 mg/dL.
I B
In all people with type 2 diabetes LDL-C < 2.5 mmol/L (less than
~ 100 mg/dL) is the primary target. Non-HDL-C < 3.3 mmol/L
(130 mg/dL) and apo B < 100 mg/dL are the secondary targets.
I B

Ray KK et al. Eur Heart J 2014 Mar 17 [Epub ahead of print]

Comparison of individuals who should
be targeted for lipid modification
Ray KK et al. Eur Heart J 2014 Mar 17 [Epub ahead of print]

Tips to help compliance with
multiple drug therapies
● Simplify the dosing regimen if possible by reducing daily doses and
concomitant medications.
● Choose cheaper alternatives.
● Provide clear written and oral instructions.
● Undertake a dialogue with the patient regarding adherence.
● Tailor the regimen to the patient’s lifestyle and needs.
● Involve the patient as partner in the treatment.
● Use behavioural strategies (reminder systems, cues, self-monitoring,
(feedback, reinforcement).

Percentage reduction of LDL-C requested to
achieve goals as a function of the starting value
STARTING LDL-C % REDUCTION TO REACH LDL-C
mmol/L ~ mg/dL
< 1.8 mmol/L
(~ 70 mg/dL)
< 2.5 mmol/
(~ 100 mg/dL)
< 3 mmol/L
(~ 115 mg/dL)
> 6.2 > 240 > 70 > 60 > 55
5.2–6.2 200–240 65–70 50–60 40–55
4.4–5.2 170–200 60–65 40–50 30–45
3.9–4.4 150–170 55–60 35–40 25–30
3.4–3.9 130–150 45–55 25–35 10–25
2.9–3.4 110–130 35–45 10–25 < 10
2.3–2.9 90–110 22–35 < 10 –
1.8–2.3 70–90 < 22 – –

A systematic review and meta-analysis
on the therapeutic equivalence of statins
Weng TC, et al. J Clin Pharm Ther. 2010;35;139-151
Mukhtar RY, et al. Int J Clin Pract. 2005;59(2):239-252
A10 A20 A40 A80 F20 F40 F80 L20 L40 L80L10 P10 P20 P40 S10 S20 S40 S80 R5 R10 R20 R40 P1 P2 P4
ATOR FLUVA LOVA PRAVA SIMVA ROSU PITA
70
60
50
40
30
20
10
0
LDL%

VOYAGER
VOYAGER: an indiVidual patient data meta-analysis Of statin
therapY in At risk Groups: Effects of Rosuvastatin,
atorvastatin and simvastatin
• VOYAGER1 is an individual patient data meta-analysis
of 32 258 patients from 37 studies
– >4 weeks duration
– fixed-dose comparisons of rosuvastatin with
atorvastatin or simvastatin
– lipid levels recorded at baseline and on therapy
• Present analysis
– data from 30 102 patient exposures to daily
treatment with rosuvastatin 10–40 mg or
atorvastatin 10–80 mg
– only data from randomised studies directly
comparing treatments were used
1. Nicholls SJ et al. Am J Cardiol 2010; 105: 69–76.

The VOYAGER population
†Studies involving forced-titration to higher statin doses meant
that there was a greater number of ‘exposures’ to individual
doses of statins than there were patients within the overall
VOYAGER population
Updated: 12 Sept 2012
Whole population
n=32 258
Nicholls SJ et al. Am J Cardiol 2010; 105: 69–76
Barter PJ et al. J Lipid Res
2010; 51(6): 1546–53 (HDL-C analysis)
(38 199 patient exposures†)
High-risk population
n=21 656
Lundman P et al. Atheroscler Suppl 2011; 12:
164 (abstract) (5741 patient exposures†)
Diabetes n=8859
Karlson BW et al. Nut Metab Cardiovasc Dis
2012; 22: 697–703
Age
Nicholls S et al. Atheroscler Suppl
2010; 11: 119 (abstract)
21% of patients ≥70 y
Gender
Lundman P et al. Atheroscler Suppl
2010; 11: 75 (abstract)
43% of patients female
Atherosclerotic disease n=15 498
Nicholls S et al. Atheroscler Suppl
2009; 10: 964 (abstract)
LDL-C goal achievement
Karlson B et al. Eur Heart J
(Suppl) 2011; 32: 342 (abstract)
Atherogenic dyslipidaemia n=6061
(7673 patient exposures†) Lipid ratios
Nicholls S et al. Eur Heart J
(Suppl 1) 2010; 31: 391 (abstract)
Karlson BW et al. European Atherosclerosis
Society Congress, May 2012 (abstract 170)
High-risk high baseline LDL-C
Lundman P et al. Atheroscler Suppl
2011; 12: 164 (abstract)
(5741 patient exposures†)
Achievement of 2011 Eu LDL-C goals
Karlson BW et al. Int Symposium Atheroscler
March 2012; (abstract 181)
Karlson BW et al. European Atherosclerosis Society
Congress, May 2012; (abstract 409)
hsCRP analysis
Nicholls SJ et al. European
Atherosclerosis
Society Congress, May 2012 (abstract
432)
(6413 patient exposures†
with baseline hsCRP recorded)

Change in LDL-C Levels with Increasing
Dose of Each Statin:
VOYAGER Whole Population
Adapted by permission from Elsevier Inc.
ChangeinLDL-Cfrom
baseline(%)
Dose (log scale)
5 mg 10 mg 20 mg 40 mg 80 mg
-27
(n=365)
-33
(n=2929)
-39
(n=548) -45
(n=479)
-50##
(n=2072)-55‡
(n=2983)
-50†
(n=3554)
-44*
(n=11
690)
-39
(n=670)
-36
(n= 7837)
-41#
(n=3908)
-46
(n=1324)
*p<0.001 rosuvastatin 10 mg vs atorvastatin 10 mg and 20 mg; simvastatin 10 mg, 20 mg and 40 mg
†p<0.001 rosuvastatin 20 mg vs atorvastatin 20 mg and 40 mg; simvastatin 20 mg ,40 mg and 80mg
‡p<0.001 rosuvastatin 40 mg vs atorvastatin 40 mg and 80 mg; simvastatin 40 mg and 80 mg
#p<0.05 atorvastatin 20 mg vs rosuvastatin 5 mg ##p<0.05 atorvastatin 80 mg vs rosuvastatin 5 mg
and 10 mg

Percentage of patients achieving treatment
goal LDL-C <100 mg/dL
Rosuvastatin 20 mg versus atorvastatin 20 mg
9 direct comparison studies
Comparison of fitted curves: odds ratio = 2.92, p<0.001
Baseline LDL-C, mg/dL (mmol/L)
120 140 160 180 200 220
0
20
40
60
80
100
%patientsachievingLDL-C
<100mg/dL(2.6mmol/L)
Rosuvastatin 20 mg (n=2017)
Atorvastatin 20 mg (n=1910)
(3.1) (3.6) (4.1) (4.7) (5.2) (5.7) (6.2)
240

Percentage of patients achieving treatment
goal LDL-C <100 mg/dL
Rosuvastatin 20 mg versus atorvastatin 40 mg
5 direct comparison studies
Comparison of fitted curves: odds ratio = 1.93, p<0.001
120 140 160 180 200 220 240
0
20
40
60
80
100
%patientsachievingLDL-C
<100mg/dL(2.6mmol/L)
Rosuvastatin 20 mg (n=628)
Atorvastatin 40 mg (n=624)
Baseline LDL-C, mg/dL (mmol/L)
(3.1) (3.6) (4.1) (4.7) (5.2) (5.7) (6.2)

High-risk patients achieving the new
European LDL-C goal
(LDL-C <70 mg/dL or >50% reduction)
100
80
60
40
20
0
Patientsatgoal(%)
2010 40 80
Statin dose (mg)
Rosuvastatin Atorvastatin
n=7583
n=2246
n=1990
n=5226
n=2818
n=898
n=1554
Simvastatin
n=174
n=428
n=2099n=59
R
R
R
R
S
A
A
A
A
A
S
S
S
S

CONTROLLED CLINICAL TRIALS
PROVIDE HIGH QUALITY DATA BUT
• Exclude specific subgroups of patients
• Exclude concomitant unwanted treatments
• Adhesion and compliance are at high level

Relation between proportional reduction in incidence
of major coronary events and major vascular events and
mean absolute LDL cholesterol reduction at 1 year
Cholesterol Treatment Trialists’ (CTT) Collaborators Lancet 2005;366:1267-78

REAL LIFE
• Less selected patients
• Coadministration of potentially interfering
drugs
• Adherence and persistence less than optimal
IS THERE A PRICE TO PAY?

 WHO describes poor adherence as
a worldwide problem with striking
magnitude
 Poor adherence itself is a problem
which should be viewed as
diagnosable and treatable !
JAMA 2013;309:2105

Chowdhury et al., EHJ 2013;34:2940–8
Prevalence of good adherence (>80%) to CV
medications
among participants in prospective studies
Meta-analysis of 44 studies, n= 1 978 919; 135 627 CVD events; 94 126 cases of all-cause
mortality
40%
poor adherence

Statin Under-dosing is associated with an
Adverse Outcome
Rasmussen et al., JAMA. 2007 Jan; 297(2):177-186

Shalev V, et al. Arch Intern Med 2009; 169:260-268
Proportion of Days Covered With Statins and All-Cause
Mortality, Maccabi Healthcare Services, Israel, 1998-2006

Risk of IHD (Hospital Diagnosis) in Patients Treated with Statin
(n = 190.877)
Catapano, et al., in preparation
Months with
drug available
< 6
7-12
13-24
25-36
≥ 36
HR (95% CI)
0.97 (0.79-1.18)
0.87 (0.73-1.03)
0.75 (0.62-0.91)
0.75 (0.59-0.94)
0.5 1.0 2.0
HR
P for trend
= 0.0007

Corrao G et al. Atherosclerosis 2014;234:224-9

Flow chart of inclusion and exclusion criteria

Characteristics of
the 458 case patients
hospitalized for acute
kidney injury and
of the corresponding
1824 controls included
into the study
Corrao G et al.
Atherosclerosis 2014;234:224-9

Association between
the statin type
employed at treatment
initiation (upper panel)
and during the current
time-window (lower
panel) and the risk of
hospitalization for
acute kidney injury
Odds ratios, and corresponding 95%
confidence intervals, of acute kidney
injury associated with dispensing:
(upper panel) high vs. low-potency statin
at treatment initiation (lower panel) high
and low-potency statin during the
current time-window, vs. any statin
dispensation during the same period.
Estimates are unadjusted (crude) and
adjusted for use of other drugs,
hospitalization for heart failure, and
Charlson comorbidity index score
Corrao G et al.
Atherosclerosis 2014;234:224-9

Effect of acute exposure to high-potency statin on the onset of
acute kidney injury during the first six months after therapy
starting (main analysis), the onset of acute kidney injury during
the first twelve months after therapy starting, and the onset of
chronic kidney injury within six months after starting therapy

Jesus Millan
Nuñez-Cortes
Juan Pedro-
Botet Montoya
Chair Co-Chair

The ESC/EAS Guidelines

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