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Lipid Workshop

Collaboration
First Case

Educational Support by

PT AstraZeneca Indonesia

Lipid Workshop Case


A 60-year old gentleman came into your office consulting his lipid profile.

He was hypertensive, controlled with antihypertensive drugs.

Not a smoker

Not aware of diabetes

No family history of CAD

History of heart attack, 1 year ago

Dyslipidemic, being treated with simvastatin 20 mg/day.

Physical examination were as follows:

Blood pressure 120/80 mmHg.


Other physical findings were non-remarkable

Lipid profile revealed:

Total Cholesterol 219 mg/dL,


LDL-C 145 mg/dL,
HDL-C 38 mg/dL,
Triglyceride 180 mg/dL.

Fasting blood glucose and liver enzymes were within normal limits
Chest x-ray normal, ECG showed old anteroseptal wall MI

What was the 10 year risk of CAD?

Very high risk


High risk
Moderate risk
Low risk

STEP 1

Estimation of patients
risk level by performing
risk assessment

Risk Categories
CHD
CHD risk equivalent
Major risk factor

Reiner Z, et al. EHJ;2011:32:1769-1818


NCEP. JAMA 2001;285: 2486-2497.
Grundy et al. Circulation. 2004;110:227-239

CHD as a Risk Indicator


Documented CHD by invasive or non invasive
testing
(angiography, nuclear imaging, stress
echocardiography)
Stable angina
Unstable angina
Myocardial infarction
Clinically significant myocardial ischemia
Coronary artery procedures (angioplasty or
CABG)

Reiner Z, et al. EHJ;2011:32:1769-1818


NCEP. JAMA 2001;285: 2486-2497.
Grundy et al. Circulation. 2004;110:227-239

Coronary Heart Disease Risk Equivalent


Peripheral arterial disease
Non-coronary forms

Abdominal aortic aneurysm

of atherosclerotic
disease
Diabetes Mellitus
type II
Diabetes Mellitus
type I
Chronic kidney
disease

Reiner Z, et al. EHJ;2011:32:1769-1818


NCEP. JAMA 2001;285: 2486-2497.
Grundy et al. Circulation. 2004;110:227-239

TIA/Stroke

Fasting blood glucose of 126 mg/dL or


greater
With target organ damage (e.g.
Microalbuminuria)
eGFR < 60 mL/min/1.73 m2

Major Risk Factors


Gender
Age
Systolic Blood Pressure
Total Cholesterol
HDL-C
Smoking

Reiner Z, et al. EHJ;2011:32:1769-1818

High CVD

Bax, Jeroen et al; EHJ; 2011;32:1769-1818

Low CVD

Risk Level
Very High risk

Known CVD includes ischemic stroke and PAD


Type 2 diabetes or type 1 diabetes with TOD such as microalbuminuria
CKD with eGFR <60ml/min/1.73m2
A calculated 10 year risk SCORE 10%.

High risk

Markedly elevated single risk factors such as familial dyslipidaemias and


severe hypertension.

A calculated SCORE 5% and <10% for 10-year risk of fatal CVD.


Moderate risk

Subjects are considered to be at moderate risk when their SCORE is 1%


and <5% at 10 years

Low risk

The low risk category applies to individuals with SCORE <1%.

Reiner Z, et al. EHJ;2011:32:1769-1818

What was the target LDL-C level?

< 70 mg/dL
< 100 mg/dL
< 130 mg/dL
< 160 mg/dL

STEP 2

Determine dyslipidemia
and the treatment target

Treatment Targets of LDL-C

Risk Category

LDL-C

Moderate Risk

< 115 mg/dL

High Risk

< 100 mg/dL

Very High Risk

Reiner Z, et al. EHJ;2011:32:1769-1818

< 70 mg/dL

In high-risk or moderately high-risk persons, it is


advised that intensity of therapy be sufficient to
achieve at least 40% reduction in LDL-C levels.1
In very high risk persons who can not reach target
level, the is recommended to be reduced 50%
from baseline.2

1. Grundy SM, et al. J Am Coll Cardiol


2004;44:720-32

Appropriate therapy for this patient would be:


TLC
TLC + statin
TLC + statin + ezetimibe
TLC + statin + fibrate
TLC + statin + niacin

STEP 3

Determine
intervention strategies

Intervention Strategies
Depending on Total CV Risk and LDL-C Level
Total CV
Risk
(SCORE)
%

LDL C (mg/dL)
<70

70 <100

100 <155

155 <190

190

<1

No
intervention

No
intervention

LSI

LSI

LSI, drug if
uncontrolled

1 <5

LSI

LSI

LSI, drug if
uncontrolled

LSI, drug if
uncontrolled

LSI, drug if
uncontrolled

>5 <10,
or high risk

LSI,
consider
drug if MI

LSI,
consider
drug if MI

LSI + drug
therapy

LSI + drug
therapy

LSI + drug
therapy

10, or
very high
risk

LSI,
consider
drug if MI

LSI + drug
therapy

LSI + drug
therapy

LSI + drug
therapy

LSI + drug
therapy

LSI = Lifestyle Intervention


MI = Myocardial Infarction

Reiner Z, et al. EHJ;2011:32:1769-1818

Lifestyle Interventions aimed to:


Lower LDL-C

Increase HDL-C

Lower TG

Reduce dietary saturated fat


Increase dietary fiber
Reduce total amount of dietary carbohydrate
Reduce alcohol intake
Increase habitual physical activity
Reduce excessive body weight
Quit smoking
Reiner Z, et al. EHJ;2011:32:1769-1818

Lifestyle Intervention (LSI)


Low Risk Group
Visit 1
Check lipid profile
Start LSI

6 weeks

Visit 2
LDL goal not achieved
Intensify LSI
6 weeks

Visit 3
LDL goal achieved
Continue LSI

Visit 3
LDL goal not achieved
Drug therapy

Monitor adherence every 4-6 months

MANAGEMENT
Define baseline LDL-C

145 mg/dL

Define LDL-C goal

< 70 mg/dL

Define % LDL-C
lowering

Minimum
51,72%

LDL-C Reduction With Each Titration of


Rosuvastatin, Atorvastatin, Simvastatin, or
Pravastatin
Rosuvastatin (mg)

Atorvastatin (mg)

Simvastatin (mg)

Mean %
Change
in LDL-C
From
Untreated
Baseline

p<0.002 vs atorvastatin 10 mg; simvastatin 10, 20, 40 mg; p<0.002 vs


atorvastatin 20, 40 mg; simvastatin 20, 40, 80 mg; pravastatin 20, 40 mg;

p<0.002 vs atorvastatin 40 mg; simvastatin 40, 80 mg; pravastatin 40 mg


Jones PH et al. Am J Cardiol. 2003;92:152160

Pravastatin (mg)

Serum Lipids Improvement with Pitavastatin


(Dose response study at week 12)
TC

LDL-C
(mg/dL)

(mg/dL)

300

(mg/dL)

65

350

250

200

HDL-C

204.8*
198.7*
(88)
(81)

218.2*
(79)

300

288.2*
281.4*
(90)
(90)

56.1
(80)

250

150

200

(83)

135.7

100
0

116.8
(75)
***

-34%

***

59.0
(81)

60

55

222.0

(81)

61.8
(83)

299.0*
(84)

-42% -47%

(90)

200.5

200.2

(80)

(81)

51.1*

50

115.1
(76)

55.0*

***

1 mg/day 2 mg/day 4 mg/day

49.6*

150
***

***

-23% -29% -33%

1 mg/day 2 mg/day 4 mg/day

( ) :Number of cases
week 0
*** : p<0.001 (vs. week 0) by one sample t-test
Subjects: Hypercholesterolemia (including FH)
Dosage: 1mg, 2mg or 4mg, once a day for 12 weeks

***

***

(90) ***

+7.3 mg/dL+5.9

mg/dL

(84)
***

+7.9

mg/dL

1 mg/day 2 mg/day 4 mg/day

Saito Y, et al. J. Clini. Ther. Med. 2001; 17: 829

Adding ezetimibe to low dose statin is


recommended for high or very highrisk patients who cannot tolerate high
dose statin to reduce LDL-C at a
minimum of 50% from baseline.

Minimum Drug Dose to Achieve


50% LDL-C Reduction
Drug
Atorvastatin
Ezetimibe/simvastatin
Rosuvastatin
Jones PH et al. Am J Cardiol 1998;81:582587
Jones PH et al. Am J Cardiol 2003;92:152160
Ballantyne CM et al. Am J Cardiol 2004;93:14871494
Ballantyne CM et al. Am Heart J 2005;149:464473

Dose, mg/d

LDL-C
reduction, %

80

5154

10/20

51

20

52

STEP 4
Secondary target achievement if
primary target has been achieved
in high risk or very high risk
patients with TG higher than 200
mg/dL

TG 200 mg/dL
TG 500 mg/dL

TLC
Immediate fibrate therapy

High or very high 10-year risk of CHD


Yes

No

LDL-C is above target

LDL-C is above target

TLC and statin therapy

TLC and statin therapy

regardless of current
LDL-C level and CHD
risk

LDL-C target is achieved


but TG is stil 200mg/dL

Consider fenofibrate
addition

Non-HDL-C is apo-B containing


lipoprotein (IDL, VLDL, and LDL)
Non-HDL-C = TC - HDL
Non-HDL-C target is 30 mg/dL above
LDL-C target

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