Prevention – Updates and Paradigm Shifts Andrew Freeman...

Prevention – Updates and Paradigm Shifts

Andrew Freeman, MD, FACC

Director of Clinical Cardiology and Operations

National Jewish Health

Assistant Professor of Medicine

National Jewish Health and University of

Colorado

Disclosure

Andrew Freeman, MD, FACC

― Consultant: Gilead

― Speaker: Medtronic

Changes Ahead

• More than a Decade of LDL goals

• Regular Lipid Panels

• Chasing Numbers

Typical Diets?

• Gone!

• New guidelines change the paradigm

• Perhaps easier, more patient-centric

• Less numbers based (in some ways)

Don’t Forget the Patient

“Guidelines attempt to… meet the needs of patients in most circumstances and are not

a replacement for clinical judgment.”

“The ultimate decision about care of a particular patient must be made by the healthcare provider and patient in light of the

circumstances presented by that patient.”Stone et al. 2013 ACC/AHA Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults

New Lipid Guidelines• Focus on Atherosclerotic Cardiovascular Disease

(ASCVD) reduction

• 4 Statin Benefit Groups

• New global risk assessment calculator for

primary prevention patients

• Safety recommendations

• Role of biomarkers and noninvasive tests

• Planned further updates to cholesterol guideline

New Guideline Departures• ABANDONMENT of LDL GOALS

• RELATIVE ABANDONMENT of nonstatin cholesterol

medications unless there are significant troubles

attaining goals

• FOCUS ON lifestyle modification including non-tropical

oils, low fat diet

•

Stone NJ, et al. Circulation. 2013: published online before print November 12, 2013.

Everyone Else: Calculate Risk

Calculator

Key Point 1: 4 Groups

http://www.cardiosource.org//~/media/Images/Advocacy/I13116_INFOGRAPHIC_Lipids_Guidelines_v2.pdf

Secondary Prevention: The No Brainer

•


What Constitutes “High Intensity?”

•


Large Studies Looking at those with ASCVD

LaRosa JC, et al. N Engl J Med. 2005;352:1425-1435.

Primary Prevention LDL > 190

•


Primary Prevention DM2

Primary Prevention – All Others


Additional Factors

• Other factors that may indicate elevated ASCVD risk were not included in the Pooled

Cohort Equations.

• In selected individuals who are not in one of statin benefit groups

– Primary LDL–C ≥160 mg/dL or other evidence of genetic hyperlipidemias,

– Family history of premature ASCVD with onset <55 years of age in a first degree

male relative or <65 years of age in a first degree female relative,

– high-sensitivity C-reactive protein >2 mg/L

– CAC score ≥300 Agatston units or ≥75 percentile for age, sex, and ethnicity

– ankle-brachial index <0.9, or elevated lifetime risk of ASCVD.

• Additional factors may be identified in the future.


ASCVD Risk Estimator App

•

What is it?

�A companion tool to the 2013 ACC/AHA

Guideline on the Assessment of

Cardiovascular Risk.

�Enables health care providers and patients to

estimate 10-year and lifetime risks for

atherosclerotic cardiovascular disease

(ASCVD) using the Pooled Cohort Equations

and lifetime risk prediction tools.

�Provides Clinician and Patient references

Where is it Available?

�The application is available on iOS and

Android platforms for both smart phones and

tablets. Additionally, a web version is available

on CardioSource and at AHA.

Search for ““““ASCVD Risk Estimator”””” on iTunes or Google Play, or go to

http://www.cardiosource.org/science-and-quality/practice-

guidelines-and-quality-standards/2013-prevention-guideline-

tools.aspx

Rollout Statistics

�Over 27,000 downloads since launch

�4,000+ daily user sessions, and growing!

�Named the top iPhone medical app for the

month of February by iMedicalApps

A Quick Reminder on Efficacy

How Am I Doing?


Bored?

Safety Modifiers

Use moderate-intensity statin therapy in individuals whom high-intensity

therapy is recommended, but characteristics predisposing them to

adverse effects:

• Multiple or serious comorbidities

• Previous statin intolerance or muscle disorders

• Unexplained ALT elevations >3 times ULN

• Patient characteristics or concomitant use of drugs affecting statin metabolism

• >75 years of age


Diabetes Alert

• Individuals receiving statin therapy should be evaluated

for new-onset diabetes mellitus and those who develop

diabetes mellitus during statin therapy should engage in

CV risk reduction lifestyle modifications and continue statin therapy to reduce their risk of ASCVD


Non-Statin Favorites – No More!

• The panel could find no data supporting the routine use of

nonstatin drugs combined with statin therapy to reduce further

ASCVD events

• In individuals who are candidates for statin treatment but are

completely statin intolerant, it is reasonable to use nonstatin

cholesterol lowering drugs that have been shown to reduce

ASCVD events in RCTs if the ASCVD risk reduction benefits.


Other Tests: More Data Needed

• VAPNot specificially endorsed. Useful for non-fasting checks and particle size measurement.

• Lp(a)In AIM-HIGH, the additional reduction in non-HDL–C [as well as additional reductions in Apo B, Lp(a), and triglycerides in addition to HDL–C increases] levels with niacin therapy did not further reduce ASCVD risk in individuals treated to LDL–C levels of 40 to 80 mg/dL

• CRPNo specific mention; useful when additional info is needed.

Non Statin Plans

• Ok well that’s all and great, but what about ezetimibe, niacin, PCSK9, fibrates, etc?

Other Possibilities?

Here’s Where it Gets Tricky

• With ASCVD, maximize statin, then

– Add ezetimibe first

– Consider PCSK9 second

Onward…

With Comorbidities

• Patients in this group have ASCVD with comorbidities including:

• diabetes

• recent (<3 months) ASCVD event

• ASCVD event while on statin

• Elevated Lp(a)

• CKD not on HD

With Comorbidities

• consideration of the lower LDL-C threshold (<70 mg/dL)

• non–HDL-C threshold (<100 mg/dL for patients with diabetes).

With Comorbidities

Clinical ASCVD and LDL > 190

• Can opt for PCSK9 up front, once maximized on statin

• OR can go with ezetimibe and bile acid sequestrant

• Lipid apheresis can be used if LDL > 190 in this group if maximally treated and HeFH

No Clinical ASCVD, LDL > 190

• Experts suggest PCSK9 only if already on maximal statin; no clear guidance if statin intolerant

DM2, No clinical ASCVD

DM2, No Clinical ASCVD, >

7.5% Risk• Use high intensity statin

• Add ezetimibe if not anticipated results (50% LDL reduction)

Still Some Questions

• What about statin intolerant patients?

• What if patients who were on statins have to come off due to LFT, CK, etc elevations?

• Ezetimibe intolerance?

Prevention – Updates and Paradigm Shifts Andrew Freeman...

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