Master Class on Dyslipidemia

National Minority Cardiovascular Alliance

The National Minority Cardiovascular (NMC) Alliance is an organization committed to eliminating minority cardiovascular health disparities. Our work considers the influence of culture, genetics, and social determinants on cardiovascular health.

Objective

Optimize communication

between providers and racial and ethnic

minority patients with dyslipidemia

Enhance treatment and improve

health outcomes

Project Design

Interviews with clinicians focused

on barriers to dyslipidemia

treatment adherence for

racial and ethnic minority patients

Moderated group discussions with racial and ethnic minority patients

to understand barriers

associated with provider

communication

Development and launch of training

program for clinicians to

optimize communication

Introducing COACH

Master Class on DyslipidemiaWhy Dyslipidemia?

High prevalence of dyslipidemia among

historically underrepresented racial and ethnic groups

Condition is not considered a priority particularly

among those with comorbidities which many racial and ethnic minority

patients are faced with

Overview of Master Class

• Research validated our anecdotes – patients do not understand the condition and associated risks of dyslipidemia. This can be improved by better patient – clinician communication

• Goal of the Master Class: • To support goal setting and patient education

• Empower relationship building so that as life changes occur - patients and clinicians have tools for continued success

SES and patient education/ health literacy levels influence

hypercholesterolemia awareness, disease state

understanding and adherence to medication.

Clinicians pointed out some noteworthy differences between

patients of different races/ethnicities:

7

Unique Patient Characteristics

Source: 2019 NMCA Focus Groups

Findings: Patient focus group - Medication

8

• Many patients said that clinicians gave them a year to get their numbers back in line before prescribing medication

• Patients show confusion about which medications are for which of their conditions

• If patients do not feel symptoms of high cholesterol, there is an aversion to taking medication; once providers explain the risks, patients are more adherent.

• Patients do not read the information with the prescription, because they would never take the medication after reading all the warnings and side effects

• They have concerns about side effects – specific issues, and overall feeling of “being off”

• Patients do not want to take a medication for life

Source: 2019 NMCA Focus Groups

Findings: Patient focus group

9

• Knew there were different numbers, but unsure about what they all meant

• Wonder if everyone gets high cholesterol as they age

• Doctors focus more on blood pressure than cholesterol, giving the sense that high cholesterol is less of a risk

• Family members with same condition keep tabs on each other

• Consideration of everyone’s health conditions when deciding what to cook

Perspectives from women

• Women in their lives made them get checked out

• Praise for female clinician, more caring

• Stopped eating or reduced consumption of eggs

• Sometimes forget to take medications

• Patients do not go to their doctor because they are afraid of what they might find

Perspectives from men

Source: 2019 NMCA Focus Groups

Findings: Clinician Interviews

10

Clinicians believe that high cholesterol is less of a health

concern for their minority patients because they are more

worried about controlling diabetes and/or hypertension

Recommendations for Clinicians

• Refer to nutritionist. Patients find it helpful to know food groups and see serving sizes

• Request for stepped or incremental changes, so patients won’t feel like a failure and quit all treatment

• Difficulty when seeing a different clinician in the same practice, patients receive different advice, even different prescriptions

• Desire to have a good relationship with clinician so they are more comfortable talking

• Encouraging patients to write down questions ahead of time is helpful

Patients closely associated unmanaged diabetes with

blindness or amputation and unmanaged hypertension with

stroke, but they do not tie unmanaged lipid levels to

cardiovascular events

Source: 2019 NMCA Focus Groups

11

Findings: Clinician InterviewsMedication adherence barriers cross cultures and demographics

Clinicians mentioned a number of adherence hurdles:

• Reluctance to take a lifelong therapy, especially among patients already taking many medications

• Access, or a change or loss of insurance

• Lower health literacy in minority communities; patients do not understand the effect of high cholesterol on cardiovascular disease

• Belief that nutraceuticals or other natural remedies can lower cholesterol levels

• Anecdotes about family members that suffered side effects such as liver disease, muscle or stomach pain from statin use

Source: 2019 NMCA Focus Groups

Communication Model: COACH

Camden Coalition of Healthcare Providers• Spent two years studying and adapting best practices from

business qualitative methods and patient centered care to define and develop a care model for it’s patient population.

• Authentic Healing Relationship: a respectful, trusting, and non-judgmental partnership between the Care Team and the patient that serves as the foundation for progress toward long term health management.

• COACH is a framework to engage and work with patients with the goal of positive behavior change.

For more information about the Camden Coalition of Healthcare Providers, please visit: https://camdenhealth.org/

12 Source: COACH Manual, 2016

Theoretical Overview

• COACH is a robust framework inclusive of:• 3 well-established and proven behavior change theories Empowerment

Theory, Unconditional Positive Regard, and Transtheoretical Theory

• Framework includes motivational interviewing as one of its key strategies, specifically utilizing reflective listening, and open-ended questions to develop a collaborative relationship to inspire motivation to change

• In this venue, the framework supports effective patient-provider communication on the topic of dyslipidemia, ensuring patients understand the implications of their diagnosis in a culturally informed way.

Source: COACH Manual, 2016

CONNECT Tasks with Vision and PrioritiesEnsure patient understands connection between hypercholesteremia and cardiovascular risks; and how that affects his/her long term goals.

OBSERVE the Normal RoutineUnderstand how patient manages his/her health condition, as well as social issues and barriers.

ASSUME a Coaching Style: “I do, You Do, We Do”Understand how to best communicate with your patient based on his/her strengths.

CREATE a Backwards PlanDevelop a care plan based on the patient’s priorities and identify the steps necessary to achieving goals.

HIGHLIGHT Progress and Process with DataMonitor the patient’s progress and process with repeat test results and communicate progress over time.

Lipid Management Follows the Guidelines

Primary Prevention of CVDManagement of Blood Cholesterol

2018 Guideline on Management of Blood Cholesterol

➢Emphasis is on a heart-healthy lifestyle from adolescence onward: • For young adults age 20-40, the assessment of lifetime risk is promoted and

emphasis placed on comprehensive and intensive lifestyle improvements to prevent development of the metabolic syndrome

• For all patients, dietary and exercise improvements are encouraged

➢In addition to lifestyle intervention, statins remain first line therapy for patients in any of these categories. There is support for the selective use of adjunct non-statin medications for LDL-C reduction in high-risk patients:

• In adults with clinical ASCVD, the addition of ezetimibe should be considered if LDL-C remains ≥70 mg/dL after a patient is on maximally tolerated statin therapy

• For patients with very high ASCVD risk (recent ACS, h/o MI/stroke, PAD) already on maximally tolerated statin and ezetimibe, adding a PCSK9 inhibitor (alirocumab or evolocumab) should be considered if the LDL-C remains ≥70 mg/dL

Source: 2018 Clinical Practice Guideline on the Management of Blood Cholesterol

Primary Prevention Guidelines

Source: 2018 Clinical Practice Guideline on the Management of Blood Cholesterol

Guideline on Primary Prevention of CVD

Top take-home points for clinicians:

Prescribe pharmaco-

therapy

Conduct risk assessment

Recommend lifestyle

modifications first

• Adopt healthy lifestyle• Consume healthy diet• Incorporate exercise• Quit smoking

• Conduct 10-year ASCVD risk estimation for adults 40-75

• Promote healthy lifestyle and evaluate for pharmacotherapy for adults with DM

• Use statin therapy first-line in at-risk patients

• Aspirin not routinely recommended

Importantly: clinicians should evaluate the social determinants of health that affect individuals to inform treatment decisions

Source: 2019 Clinical Practice Guideline on the Primary Prevention of Cardiovascular Disease

Race/Ethnicity Factors

Examples:

• Heightened risk of ASCVD in those who identify as South Asians

• Increased sensitivity to statins in those who identify as East Asians

• Increased prevalence of hypertension in blacks

• Higher rates of risk factors for ASCVD in Native Americans/ Alaskan natives than non-Hispanic whites

Race/ethnicity factors can influence:

• Estimations of ASCVD risk

• Intensity of treatment

• Lipid drug use

Race/ethnicity factors should be considered in clinical management.

Source: 2019 Clinical Practice Guideline on the Primary Prevention of Cardiovascular Disease

Secondary Prevention Guidelines

*Very high-risk includes a history of multiple major ASCVD events or 1 major ASCVD event and multiple high-risk conditions

Source: 2018 Clinical Practice Guideline on the Management of Blood Cholesterol

Guideline on Management of Blood Cholesterol

Top take-home points for clinicians:

For clinical ASCVD, use with high-intensity or maximally

tolerated statin therapy

For very high-risk ASCVD, consider addition of non-

statins – ezetimibe, followed by PCSK9i

For severe primary hypercholesterolemia, begin high intensity statin therapy; potentially add non-statins –

ezetimibe, followed by PCSK9i

In adults 40 - 75 without DM and intermediate risk, initiation of

statin therapy is favored

For Adults 40 – 75 without DM and with LDL-C ≥70 - 189 mg/dL,

at intermediate risk, measure CAC

For adults 40 - 75 with DM and/or intermediate risk or

higher, start moderate-intensity statin therapy

Assess adherence and response to medications and lifestyle

changes with repeat lipid measurement

Recommend lifestyle modifications

Initiate therapy based on risk Assess progress

Emphasize a heart-healthy lifestyle

In adults 40 – 75, for primary prevention, have a

risk discussion before starting statin therapy

Source: 2018 Clinical Practice Guideline on the Management of Blood Cholesterol

About Lipid-Lowering Drugs and Dispelling Common Myths While statins are often prescribed, they are also often misunderstood – especially when it comes to their safety. Nine myths about statins:

Statins will hurt your ability to exercise

Statins will cause muscle damage and hurt your heart

You should avoid statins if you have diabetes

Statins cause cognitive dysfunction or dementia

Natural supplements like red yeast rice are safer than taking a statin

Being statin-intolerant means you will never be able to take a statin

Statins cause cataracts and liver damage

Everyone should take statins

The elderly do not benefit from statins

Linear Correlation Between LDL-C Lowering and Lowering Risk of CV Events in Statin Trials 1,2

IDEAL(less intense

LDL-C management)

Eve

nt

Ra

te in

Se

co

nd

ary

Pre

ve

nti

on

Tri

als

(%

)

Mean Treatment LDL-C Level at Follow-up (mg/dL)

0 20 40 60 80 100 120 140 160 180 200

30

25

20

5

0

15

10

PROVE-IT(intense LDL-C management)

HPS

TNT(intense LDL-C management)

PROVE-IT(less intense LDL-C management)

TNT(less intense LDL-C management)

LIPID HPS

4S

LIPID

MIRACL

CARE

CARE

IDEAL(intense LDL-C management)

MIRACL

A to Z(more intense LDL-C management)

A to Z(less intense LDL-C management)

Oral lipid-lowering comparator

Placebo comparator

4S

Raymond C, et al. Clev Clin J Med. 2014;81:11-19. 2. Cholesterol Treatment Trialists’ (CTT) Collaboration. Lancet. 2010;376:1670-1681.

CTTC Meta-analysis of major lipid secondary prevention statin trials conducted in 2010:

Median follow-up ~ 5 years, N = 169,1382

There is a linear correlation between LDL-C lowering and lowering risk of CV events in statin trials 1,2

FOURIER and ODYSSEYPCSK9 Inhibitors and CV Outcomes

Primary Endpoint

Composite of CV Death, MI, Stroke, Hospitalization

for UA, or Coronary Revascularization

6.0

10.7

14.6

5.3

9.1

12.6

Cu

mu

lati

ve

In

cid

en

ce

(%

) Placebo

Evolocumab

0

2

4

6

8

10

12

14

16 HR 0.85 (95% CI 0.79 to 0.92);

P < 0.001

Months

0 6 1812 24 3630

CLEAR Harmony

Primary EndpointEffects of bempedoic acid

Efficacy Of Bempedoic Acid In Patients Who Cannot Tolerate Any Dose Of A Statin:

In patients with hypercholesterolemia who cannot tolerate any dose of a statin, this post hoc analysis demonstrated a greater magnitude of LDL-C reduction by bempedoic acid compared with previously reported LDL-C reductions observed in patients receiving background statin therapy, with a similar safety profile

CLEAR Tranquility

Change from baseline to week 12 in low-density lipoprotein (LDL) cholesterol and high-sensitivity C-reactive protein

(hsCRP), post hoc population

(a) Percentage change from baseline in LDL-cholesterol (b) Percentage change from baseline in hsCRP

Ballantyne CM, et al. Bempedoic acid plus ezetimibe fixed-dose combination in patients with hypercholesterolemia

and high CVD risk treated with maximally tolerated statin therapy. Eur. J. Prev. Cardiol. 2020 Apr;27(6):593-603.

Effects of bempedoic acid + ezetimibe

REDUCE-IT – Beyond LDL loweringIcosapent Ethyl for Hypertriglyceridemia

Minority Data from Dyslipidemia Drug Trials

Trial % White* % AA* % Hispanic* % Asian*

FOURIER 85.1% 2.4% 7.9% 9.9%

ODYSSEY 79.4% 2.5% 16.6% 13.2%

REDUCE-IT 90.3% Under 10%

CLEAR Harmony 95.9% 2.6% 1.6% 1.0%

CLEAR Tranquility

82.2% 16.2% 30.6% 1.0%

AA = African Americans*Race/ethnicity categories are not independent Source: FDA Snapshot Data

Minority Data from Dyslipidemia Drug Trials

Brand Name Study Name Demographic Breakdown Notes

LipitorAnglo-Scandinavian Cardiac Outcomes Trial

Lowering Lipids Arm (ASCOT-LLA)

See NotesNo comprehensive breakdown of race, geographic region suggests primarily all

white

Crestor

1. Double-blind, placebo-controlled, dose-ranging study

2. Open-label study of 2,240 subjects with type IIa and IIb hypercholesterolemia

1. Not listed2. White (86%), Black (8%), Hispanic (4%), Other (2%)

No comprehensive breakdown of race for the double-blind, placebo-controlled

dose-ranging study

PravacholLong-Term Intervention with Pravastatin in

Ischaemic Disease Study(LIPID)

See Notes

No comprehensive breakdown of race, geographic region(Australia/NZ) suggests

primarily all white

ZocorScandinavian Simvastatin Survival Study

(4S)See Notes

No comprehensive breakdown of race, geographic region suggests primarily all

white

MevacorAir Force/Texas Coronary Atherosclerosis

Prevention Study (AFCAPS/TexCAPS)

White (89%), Black (3%), Hispanic (7%), Asian (3%) N/A

New therapy on the horizon - Inclisiran

Established Clinical Efficacy

Most common AE

Additional Data

Dose

inclisiran

300 mg SC: Day 1, Day 90, and Q26W

LDL-C Reduction: 300 mg Day 180: 53% 300

mg Day 240: 47%

Injection site reactions (5% combined incidence)

No difference vs PBO in hsCRP change

Section IIConsiderations for implementation of COACH

Implementation of COACH

COACH as a tool to:• Build relationship with patient

• How to harness technology now that visits are so mediated by computers

• Improve shared decision making• Connection to payment

• Articulate risk• Improve adherence

Frame as “thinking about convo with

patient”

Now that the clinician – patient relationship is often mediated by

technology, this framework is intended to support relationship

building and maintenance

Clinicians are balancing need to follow

guidelines, while also being culturally aware

and listening to the needs of patients

Source: COACH Manual, 2016

Implementation of COACH

• Shared responsibility among whole care team• Receptionist

• Medical Assistant

• Nursing Assistant

• Nurse

• Nurse practitioner

• Physician

• Any other clinician

• Clinicians need to follow guidelines, while also being culturally sensitive and listening to the needs of patients

Source: COACH Manual, 2016

CONNECT Tasks with Vision and Priorities- Patient’s health literacy - Patient’s goal for intervention - Patient’s long-term vision for self

OBSERVE the Normal Routine- Patient’s strengths, level of need, awareness of resources

ASSUME a Coaching Style- “I do” “We do” “You do”

CREATE a Backwards Plan- Begin with discussion of ideal outcomes, and work backwards on steps to achieve

HIGHLIGHT Progress and Process with Data- Appropriate language to use when praising patient on progress (focus on process, not person)

C - CONNECT Tasks with Vision and Priorities

Use reflective, empathic language and open-ended questions to understand what the patient’s goals are. Reflect on the patient’s short term and broader vision to motivate through the intervention.

Talk about patient’s overall vision/goals for health

Explain where/how dyslipidemia fits in

Ensure patient understands connection between dyslipidemia and CV risks

Source: COACH Manual, 2016

O - OBSERVE the Normal Routine

Meet the patient where

he/she is

Observe the patient without intervention

or judgement and ask open-ended

questions to understand how the

patient manages his/her health

condition, as well as social issues and

barriers.

Understand patient’s level of health literacy,

need, awareness of resources

Build on systems the patient already has in

place, ensure new prescription/

adaptations fit in to current normal

routine

Source: COACH Manual, 2016

A - ASSUME a Coaching Style

Understand how to best

communicate with each

patient

Chose a coaching style, for ex –

“I do,” “We do,” “You do”

Model behavior based on patient’s health literacy and existing supports

This better equips patients with

relevant skills to achieve long-term

strategies

Source: COACH Manual, 2016

C - CREATE a Backwards Plan

• Use motivational interviewing to conduct an active conversation with the patient to develop a care plan based on the patient’s priorities and identify the steps necessary to achieving long- and short-term goals.

• Develop a care plan based on the patient’s priorities and work backwards to identify the steps necessary to achieving goals

TODAY GOALStep 1 Step 2 Step 3

Source: COACH Manual, 2016

H - HIGHLIGHT Progress and Process with Data

• Monitor the patient’s progress and process with repeat test results and communicate progress over time

• Focus on efforts, as well as outcomes

• Consider appropriate language to use when praising patient on progress (focus on process, not person)

Source: COACH Manual, 2016

CONNECT Tasks with Vision and PrioritiesReinforce the link between hypercholesteremia and cardiovascular risk. Use reflective, empathic language and open-ended questions to understand what the patient’s goals are. Reflect on the patient’s short term and broader vision to motivate through the intervention.- Patient’s health literacy - Patient’s goal for intervention - Patient’s long-term vision for self

OBSERVE the Normal RoutineMeet the patient where he/she is; Observe the patient without intervention or judgement and ask open-ended questions to understand how the patient manages his/her health condition, as well as social issues and barriers. Build on systems the patient already has in place.- Patient’s strengths, level of need, awareness of resources

ASSUME a Coaching StyleChoose a coaching style (“I do,” “We do, “You do”) and model behavior based on the patient’s health literacy and support to better equip him/her with the skills to promote long-term strategies- Patient’s strengths and abilities

CREATE a Backwards PlanUse motivational interviewing to conduct an active conversation with the patient to develop a care plan based on the patient’s priorities and identify the steps necessary to achieving long- and short-term goals.- Begin with discussion of ideal outcomes, and work backwards on steps to achieve

HIGHLIGHT Progress with Data

Monitor the patient’s progress with repeat test results and communicate progress over time.- Appropriate language to use when praising patient on progress (focus on process, not person)

References• Heart Disease and Stroke Statistics – 2018 Update: A Report From the American Heart Association. Published Jan 11, 2019:

https://www.ahajournals.org/doi/10.1161/CIR.0000000000000558

• Master Class on Dyslipidemia Focus Groups. National Minority Cardiovascular Alliance. Occurred Aug 27, 2019 (CT) and Sept 19, 2019 (MS)

• COACH Manual. Camden Coalition of Healthcare Providers. 2016. https://camdenhealth.org/the-coach-model/

• Clinical Practice Guideline. 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol. A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. https://www.onlinejacc.org/content/73/24/3168

• Clinical Practice Guideline. 2019 ACC/AHA Guideline on the Primary Prevention of Cardiovascular Disease. A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. https://www.ahajournals.org/doi/full/10.1161/CIR.0000000000000678

• Raymond C, et al. Clev Clin J Med. 2014;81:11-19. 2. Cholesterol Treatment Trialists’ (CTT) Collaboration. Lancet. 2010;376:1670-1681.

• Sabatine, M. et al. Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease. NEJM. 2017; 376:1713-1722. DOI: 10.1056/NEJMoa1615664

• Schwartz, GG. et al. Alirocumab and Cardiovascular Outcomes after Acute Coronary Syndrome. NEJM. 2018; 379:2097-2107. DOI: 10.1056/NEJMoa1801174

• Ray, KK. Et al. Safety and Efficacy of Bempedoic Acid to Reduce LDL Cholesterol. NEJM. 2019; 380-1022-32.

• Ballantyne CM, et al. Bempedoic acid plus ezetimibe fixed-dose combination in patients with hypercholesterolemia and high CVD risk treated with maximally tolerated statin therapy. Eur. J. Prev. Cardiol. 2020 Apr;27(6):593-603.

• Bhatt, DL. Cardiovascular Risk Reduction with Icosapent Ethyl for Hypertriglyceridemia. NEJM 2019; 380:11-22. DOI:10.1056/NEJMoa1812792

• Inclisirian in Patients at High Cardiovasculr Risk with Elevated LDL Cholesterol. NEJM. 2017; 376:1430-40. DOI:10.1056/NEJMoa1615758

• Food & Drug Administration. Drug Trial Snapshots. https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots

Q & A

Please submit your questions through the Q&A feature or use the ‘raise your hand’ function

Visit “Ongoing Projects” at www.makewellknown.org

for more information and to view the toolkit for this Master Class.

Thank you to our sponsors for their unrestricted support of the National Minority Cardiovascular Alliance and this Master Class