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New Lipid GuidelinesWhat Has Changed ?
Atherosclerosis and Metabolic Syndrome Units,2nd Prop Clinic of Internal Medicine,
Aristotelian University, Hippocration Hospital, Thessaloniki, Greece
V.G ATHYROS, MD, FESC, FRSPH, FASA, FACS
Treatment of Hyperlipidemia
Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults. JAMA 2001;285:2486-2497.
High LDL-C
Therapeutic Lifestyle Change
Drug Therapy
Therapy of Choice: Statin
Alternative: Resin or niacin
Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults. JAMA 2001;285:2486-2497.
2001 NCEP ATP III Treatment Categories, LDL-C Goals and Cutpoints
Risk Category LDL-C GoalConsider Drug
Therapy
CHD or CHD risk equivalent <100 mg/dL 130 mg/dL*
2 Risk Factors
10-yr risk 10–20%
10-yr risk <10%
<130 mg/dL
<130 mg/dL
130 mg/dL
160 mg/dL
<2 Risk Factors <160 mg/dL 190 mg/dL
* 100–129 mg/dL = after TLC, consider statin, niacin, or fibrate therapy
Anglo-Scandinavian Cardiac Outcomes Trial—Lipid Lowering Arm (ASCOT-LLA): Study Design
• Nonfatal MI, including silent MI, and fatal CHD
Primary efficacy end point
HTN=hypertension; SBP=systolic blood pressure; DBP=diastolic blood pressure; TC=total cholesterol;
CVD=cardiovascular disease.
Sever PS et al. Lancet. 2003;361:1149-1158.
• Men and women aged 40-79 years
• Untreated HTN (SBP 160 mm Hg, DBP 100 mm Hg, or both)
• Treated HTN (SBP 140 mm Hg, DBP 90 mm Hg, or both)
• TC 251.4 mg/dL
• At least 3 additional CVD risk factors
Atorvastatin 10 mg(n=5168)
Placebo
(n=5137)
Patient population
5 years
19,342
patients
with HTN
10,305
patients with
TC 251.4 mg/dL
•Trial stopped at 3.3 years,
2 years earlier than expected
0
1
2
3
4
0,0 0,5 1,0 1,5 2,0 2,5 3,0 3,5
Έτη
Aθρ
οισ
τική
συ
χνό
τητα
36% Reduction
ASCOT: Πρωτεύον Τελικό Σημείo: Non-fatal MI – CVD death
HR = 0.64 (0.50-0.83)
Atorvastatin 10 mg Number of CVD events 100
Placebo Number of CVD events 154
p=0.0005
Sever PS, et al, for the ASCOT Investigators. Lancet. 2003;361:1149-58
LDL=130 mg/dl
LDL=90 mg/dl
NCEP ATP III: 2004 Updated LDL-C Goals, Treatment Cutpoints
Risk Category LDL-C Goal Initiate TLCConsiderDrug Therapy
Lower risk:0–1 risk factor
<160 mg/dL 160 mg/dL 190 mg/dL
Moderate risk:2 risk factors(10-year risk<10%)
<130 mg/dL 130 mg/dL 160 mg/dL
Moderatelyhigh risk:2 risk factors(10-year risk 10%–20%)
High risk:CHD or CHD risk equivalents*
(10-year risk >20%)
<130 mg/dLoptional:
<100 mg/dL
<100 mg/dL
optional:
<70 mg/dL
130 mg/dL
100 mg/dL
130 mg/dL(100–129 mg/dL: consider drug options)
100 mg/dL(<100 mg/dL: consider drug options)
Endpoint Studies: Treating to New Targets (TNT): Study Design
Site SelectionNovember 1997
InvestigatorMeeting
March 1998
RecruitmentCompleteJune 1999
Study EndDec 2004
Atorvastatin10 mg
LDL75 mg/dL
LDL100 mg/dL
5 Years
Atorvastatin80 mg
10,000 CAD Patients
TNT: Major CHD events
LaRosa JC et al. N Engl J Med. 2005;352.
22% RRR
Years
65421 3
Atorvastatin 10 mg
Atorvastatin 80 mg
0
0.00
Major CHD event (%)
0.05
0.10
0.15
HR = 0.78 (0.69–0.89)P < 0.001
Death, non-fatal MI, cardiac arest, stroke.
TNT: Stroke
LaRosa JC et al. N Engl J Med. 2005;352.
25% RRR
Years
65421 3
Atorvastatin 10 mg
Atorvastatin 80 mg
0
0.00
Stroke (%) 0.02
0.04
0.01
0.03
HR = 0.75 (0.59–0.96)P = 0.02
TNT diabetes analysis:Major CHD events
Shepherd J. American Diabetes Association 2005 Scientific Sessions; June 10-14, 2005; San Diego, CA.
25% RRR
Years
65421 3
Atorvastatin 10 mg (n= 753)
Atorvastatin 80 mg(n= 748)
0
0.00
(%) 0.10
0.20
0.05
0.15
HR = 0.75, P = 0.026
N=1.500
TNT diabetes analysis: Stroke
Shepherd J. American Diabetes Association 2005 Scientific Sessions; June 10-14, 2005; San Diego, CA.
31% RRR
Years
65421 3
Atorvastatin 10 mg (n= 753)
Atorvastatin 80 mg(n= 748)
0
0.00
(%)
0.05
0.10
HR = 0.69, P = 0.037
N=1.5000.15
The Need to Implement Secondary Prevention
Multiple studies of the use of these recommended therapies in appropriate patients continue to show that many patients in whom therapies are indicated are not receiving them in actual clinical practice
The AHA and ACC urge that in all medical care settings where these patients are managed that programs be implemented to provide practitioners with useful reminder clues based on the guidelines and to continuously assess the success achieved in providing these therapies to the patients who can benefit from them.
Encourage that the AHA’s Get With the Guidelines and/or ACC’s Guidelines Applied to Practice Programs be instituted to identify appropriate patients for therapy
AHA=American Heart AssociationACC=American College of Cardiology
AHA Get With The Guidelines (GWTG) Program
GWTG is a national initiative of the AHA to improve guidelines adherence in patients hospitalized with cardiovascular disease
GWTG uses collaborative learning sessions, conference calls, e-mail and staff support to assist hospital teams improve acute and secondary prevention care systems
A web-based Patient Management Tool is used for point-of-care data collection and decision support, on-demand reporting, communication, and patient education
Get With The Guidelines Hospital Tool Kit. Dallas, TX: American Heart Association 2006.
AHA=American Heart Association
Athyros V, et al. Curr Vasc Pharmacol 11 April 2011
95
96
97
98
99
100
0 6 12 18 24 30 36 42
Group A Group B
Δ%
Event free survival
Months
p=0.0012
ATTEMPT
Guidelines for the Diagnosis
and Treatment of Dyslipidemia
and Prevention of
Cardiovascular Disease 2009
Risk Level Initiate treatment if: Primary PrimaryLDL-C Alternate
High Consider treatment in all
patients
CAD,PVD
Atherosclerosis
Most Pts with Diabetes
FRS ≥ 20%, RRS ≥ 20%
<2 mmol/L Or ↓50% LDL-C ApoB<0.80Class I Level A Class I Level A
Moderate (strive towards )
FRS 10-19% LDL-C>3.5 mmol/L
TC/HDL >5.0
hsCRP >2
men 50+, women 60+
Family history and hsCRP modulate
risk
<2 mmol/L Or ↓50% LDL-C ApoB<0.80Class IIA Level A Class IIA Level A
LowFRS<10% LDL-C>5.0mmol/L
↓50% LDL-C
Στόχοι LDL-C κατά τισ Καναδικζσ κατευθυντήριεσ οδηγίεσ
A A
A A
A
Genest J et al. Can J Cardiol 2009 Oct;25(10):567-79
Η LDL-C remains the main therapeutic target
European Guidelines 2011
European guidelines on cardiovascular disease prevention in clinical practice: Third Joint Task Force of European and other Societies on
Cardiovascular Disease Prevention in Clinical Practice (constituted by representatives of eight societies and by invited experts)
Greek Guidelines for the Treatment of Dyslipidaemia
Level of risk for statin treatment initiation
LDL-C target
High
CHDStrokePADType 2 DM or Type 1 > 40 yearsCKD with GFR <60 ml/minFramingham score >20%
<70 mg/dlorLDL CHOL κατά 50%
MediumAt leas 2 CVD risk factors
Framingham score 10%-20%
<100 mg/dl
Low0-1 CVD risk factors without CVDFramingham score <10%
< 130 mg/dl
Greek Atherosclerosis Society 2011
Relationship Between Estimated GFR (eGFR) and Clinical Outcomes
Go AS, et al. N Engl J Med 2004;351:1296-305
Ag
e-s
tan
dard
ized
even
t ra
te (
per
100 p
ers
on
-yr) Death from any cause Cardiovascular events Any hospitalization
Total events = 51,424 Total events = 139,011 Total events = 554,651
Kaiser Permanente Renal Registry, n=1,120,295 adults aged 20 years Median follow-up = 2.84 years
eGFR (mL/min/1.73 m2)
Total cardiovascular risk should
not be shaped by LDL-C levels onlybut
it should define the LDL-C target
Treatment of Mixed Hyperlipidemia(Residual Cardiovascular Risk Reduction)
Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults. JAMA 2001;285:2486-2497.
High LDL-C and TGs
Therapeutic Lifestyle Change
Drug Therapy
Achieve the LDL-C goal1STEP
Achieve the non-HDL-C goalIncrease LDL-C lowering orAdd a fibrate, niacin or fish oils
2STEP
R3i: Τοπικζσ οργανώςεισ ςε εθνικό επίπεδο
27
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