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8/10/2019 New Lipid Guidelines
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The New L ipid Guidel inesWhat you need to know
Paul J Kovack, DO, FACOI, FACC
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Overview
• NHLBI• ACC/AHA
• First new guidelines since ATP III guideline update in 2004
• Review the most important statements or changes presented in theseguidelines
– No longer have therapeutic targets
– New risk calculator
– Use medications proven to reduce risk, ie statins
– Avoid medications or supplements that may lower the cholesterolnumber, but have no data to decrease CV risk
• This guideline focuses on treatments to reduce ASCVD events
• Not a comprehensive approach to lipid management• Finally, review questions and controversies that have arisen since
publication.
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Disclosures
• I have no disclosures for this talk
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Don’t Forget Healthy Lifestyle
• Healthy diet
• Regular exercise
• No tobacco
• Maintain healthy weight
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2013 ACC/AHA/NHLBI Guideline onLifestyle for CVD Prevention
• Eat a dietary pattern that is rich in fruit, vegetables,whole grains, fish, low-fat dairy, lean poultry, nuts,legumes, and nontropical vegetable oils consistentwith a Mediterranean or DASH-type diet.
• Restrict consumption of saturated fats, trans fats,sweets, sugar-sweetened beverages, and sodium.
• Engage in aerobic physical activity of moderate to
vigorous intensity lasting 40 minutes per session threeto four times per week
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There are 4 defined Statin Benefitgroups
• All of these are indicated for statin treatment
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1. Patients with clinical ASCVD
• Defined by the inclusion criteria for thesecondary prevention statin RCT
• Coronary artery disease or peripheral artery
disease• Acute coronary syndromes
• Coronary or other arterial revascularization
• Stroke or TIA
• PVD presumed to be atherosclerotic
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Identifying ASCVD
• This could be identified in several ways
• Heart catheterization
• Q waves on ECG
• TEE
• Coronary CTA
• Noninvasive testing including, carotid duplex,
upper or lower extremity arterial duplex• Peripheral angiography
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2. LDL greater than 190 mg/dl
• This is one of the few times level of cholesterol
mentioned in the guidelines
• These are patients with familial hyperlipidema
• They deserve special consideration
• Often start with untreated LDL of 325-400
mg/dl
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3. Patients with diabetes, age 40-75years
• All have indication for statin
• Level of intensity of statin treatment depends
on calculated 10 year risk.
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4. Age 40-75 years that do not meet abovecriteria, but have a 10 year risk of >7.5 %
• 10 year and lifetime risk as determined by CV
Risk Calculator
• Specifically designed for this trial
• Downloadable on AHA or ACC site
• Not without controversy, as the calculator has
never before been published or validated
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CV Risk Calculator
• Risk factors used in calculation – Sex
– Age
– Race
– Total Cholesterol – HDL
– Systolic BP
– Treated for HBP
– Diabetes – Smoker
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Data generated with calculator
• Patient’s 10 year risk
• 10 year risk of someone the same age with
optimized risk factors
• Patient’s lifetime risk of ASCVD
• Lifetime risk of someone with optimal risk
factor levels
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There are no longer treatment targetsfor LDL or non-HDL
• This is a huge change for patients and
providers.
• No longer treat to target
• Doesn’t fit in well with “know your numbers.”
• Goal is no longer “lower is better.”
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Non-statin therapies
• For hyperlipidemia, non statin therapies, alone or in combinationwith statins, do not provide acceptable risk reduction benefitscompared to adverse effects.
• These include:
– Zetia
– Fibrates
– Fish oil
– Niacin
• For the most part, these should be avoided with few exceptions
• Why don’t non-statins play a more prominent role in the newguidelines?
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Recent troublesome non-Statin Trials
• Fibrate
– ACCORD. N Engl J Med 2010; 362:1563-1574
– FIELD. Lancet; 366:1849-1861
• Fish oil
– Risk and Prevention Study Group. N Eng J Med2013; 368:1800-1808
– Omega-3 Fatty Acid Supplementation and Risk ofCardiovascular Events. JAMA 2012; 308(10):1024-
1033
– SELECT. JNCI 2013; July 10
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Troublesome non-Statin Trials
• Niacin – HPS2-THRIVE (Treatment of HDL to reduce the
Incidence of Vascular Events.) European HeartJournal 2013; 34:1279-1291
– AIM-HIGH N Eng J Med 2011; 365:2255-2267• Zetia
– ENHANCE. N Eng J Med 2008; 358:1431-1443
– ARBITER 6-HALTS. N Eng J Med 2009; 361:2113-2122
– SEAS. N Eng J Med; 359:1343-1356
– IMPROVE-IT ongoing
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What if you don’t fall into one of the 4categories where statins are indicated?
• There are no recommendations for treatment
in selected individuals who are not in the 4
statin benefit treatment groups
• In these individuals whose 10 year risk is lessthat 7.5%, or when the decision is unclear,
other factors should be considered
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Other factors to be considered
• Family history of premature CAD
• LDL > 160 mg/dl
• Increased CRP greater than 2.0
• Coronary calcium greater than 300
• ABI < 0.9
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What is your patient cannot toleratestatin due to muscle weakness?
• Readdress lifestyle issues
• Decrease the dose of statin
• Try another statin
• Check vitamin D levels and replace
• Evaluate for other conditions that may cause
muscle weakness
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High intensity versus low intensitystatin therapy
• High intensity statin therapy is defined as >
50% reduction of LDL with daily statin
• Moderate intensity statin therapy is defined as
30-50% reduction with daily statin• All patients with CAD, regardless of age,
should receive high intensity statin therapy if
tolerated.
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% R e
d u c t i o n i n L D L - C
19
27 28
35 37
12
1012
12
18
0
10
20
30
40
50
60
Lovastatin20/80 mg
Fluvastatin20/80 mg
Simvastatin20/80 mg
Pravastatin20/80 mg
Atorvastatin10/80 mg
Response to Minimum/Maximum Statin Dose
3137
40
47
55
Reprinted from Illingworth DR. Med Clin North Am.2000;84:23–42, with permission from Elsevier Limited.
Dose Response of Different Statins
LDL-C = low-density lipoprotein cholesterol
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Jones PH, et al. Am J Cardiol. 2003;92:152–160.
*P < 0.001 vs. atorvastatin 10 mg and simvastatin 20 mg and 40 mg†P = 0.026 vs. atorvastatin 20 mg
-60%
-50%
-40%
-30%
-20%
-10%
0%
M e a n % C
h a n
g e i n
L
D L - C f r o m
U n
t r e a t e d
B a s e l i n e V a
l u e
Atorvastatin Rosuvastatin Simvastatin
14% with3 titrations
9% with2 titrations
18% with3 titrations
10 mg 20 mg 30 mg 40 mg
−28
−7
−4
−7
−46†
−6* −3*
−37
−6
−5 −3
LDL–C=low-density lipoprotein cholesterol
Comparing statin efficacy
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Patients with LDL greater than 190mg/dl
• These patients get high intensity statin treatment• If they cannot tolerate high intensity statin therapy, use
Zetia or other agent to achieve >50% reduction ofbaseline LDL.
• Patients with FH are frequently unable to achieveprevious goals even with multiple cholesterol loweringagents
• In this special case, the authors felt that data hasshown significant reductions of ASCVD by decreasingLDL > 50%
• Can include statin plus another agent
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Diabetics aged 40-75 yoa
• Diabetics with > 7.5% 10 year risk get high
intensity statin therapy
• Diabetics with < 7.5% 10 year risk of CAD get
moderate intensity statin therapy• Statin indicated in all patients with diabetes
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Nondiabetic patients without knownCAD with >7.5% 10 year risk
• Statin indicated in these patients
• Moderate to high intensity statin therapy
recommended
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4 Defined Statin Benefit Groups
• CAD or PAD
• LDL >190 mg/dl
• Diabetics, age 40-75 years with LDL 70-189
mg/dl
• Age 40-75 years that don’t meet above criteria,
but have a calculated 10 year risk of > 7.5% of
developing CAD
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No longer appropriate strategies
• Treat to target
• Lower is better
• Treat for lifetime risk
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No recommendations for these
• No indication for starting or discontinuingstatins in the following:
– NYHA class 2-4
– Or those on dialysis
– HIV patients
– Solid organ transplant patients
– Insufficient data from RCT available
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Likely Future Updates to theCholesterol Guidelines
• How lifetime risk should be used and the optimal ageto begin statin therapy to reduce lifetime risk of
ASCVD
• Subgroups of individuals with heart failure orundergoing dialysis that might benefit from statin
therapy• Long-term effects of statin-associated new onset
diabetes and management
• Efficacy and safety of statins in patients excluded fromRCT to date (eg, HIV positive or solid organ transplant)
• Role of pharmacogenetic testing
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Controversies
• Calculator may overestimate risk and lead toinappropriate use of statins, specifically in primaryprevention.
• During the review phase of the guidelines, Dr. Ridkerand Cook pointed out that the calculator was not
working among the populations it was tested on by theguideline authors.
• Concern that the calculator over predicted risk by 75 – 150%
• So patients from a previously studied population mighthave had an actual risk of 4% but the calculator mighthave calculated a risk of 8%, warranting statin therapy.
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Controversies
• Guideline panel chairman said they believedthat the populations studied by Drs Cook and
Ridker were “unusually healthy” and so their
MI and stroke rates might be lower than
expected.
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Calculations may not always makesense
• Dr. Nissen cites examples• 47 year old African-American with TChol 160, HDL 44,
SBP 130 on 25 mg HCTZ, nondiabetic, nonsmoker has10 year risk of 7.6%
• 60 year old African-American with no risk factors, TChol150, SBP 125 on no meds, nondiabetic, nonsmoker has10 year risk of 7.5%
• Similar for a healthy white man aged 58
• 44 year old nonsmoking, nondiabetic white man with
strong family history of MI, total cholesterol of 250 mg/dl,LDL 182, HDL 28, SBP 120 on no meds has 5% calculated risk.
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Where do we go from here?
• Suspend guidelines?
• Evaluate risk calculator accuracy using current
populations and make adjustments.
• Continue guideline and review new evidenceas it becomes available
• Continue the discussion
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Summary
• No longer use targets for cholesterol levels
• Identify patients at risk
• Know the 4 high risk groups
• Use medications proven to reduce risk, ie statins
• Encourage healthy lifestyle
• Understand that questions and concerns remain
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“Now this is not the end.
It is not even thebeginn ing o f the end . But
i t is, perhaps, the end o f
the beginning”
Winston Churchill, 1942
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Questions?