New Lipid Guidelines

8/10/2019 New Lipid Guidelines

http://slidepdf.com/reader/full/new-lipid-guidelines 1/38

The New L ipid Guidel inesWhat you need to know

Paul J Kovack, DO, FACOI, FACC



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.



Disclosures

• I have no disclosures for this talk



Don’t Forget Healthy Lifestyle

• Healthy diet

• Regular exercise

• No tobacco

• Maintain healthy weight



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



There are 4 defined Statin Benefitgroups

• All of these are indicated for statin treatment



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



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



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



3. Patients with diabetes, age 40-75years

• All have indication for statin

• Level of intensity of statin treatment depends

on calculated 10 year risk.



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



CV Risk Calculator

• Risk factors used in calculation – Sex

– Age

– Race

– Total Cholesterol – HDL

– Systolic BP

– Treated for HBP

– Diabetes – Smoker



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



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.”



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?



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



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



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



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



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



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.



% 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



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



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



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



Nondiabetic patients without knownCAD with >7.5% 10 year risk

• Statin indicated in these patients

• Moderate to high intensity statin therapy

recommended



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



No longer appropriate strategies

• Treat to target

• Lower is better

• Treat for lifetime risk



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





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



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.



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.



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.



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



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



“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



Questions?

Documents

New Lipid Guidelines