el CIC WHF Cholesterol Roadmap, México ... - Academia El CIC 19 WHF CH… · Lp(a) ≥50 mg/dL....

WHF Cholesterol Roadmap, México, September 19th 2018el CICPara Vivir Más y Mejor

Enrique Morales MDWHF/SMC México Ambassador

Mexico City, September 19th 2018

WHF Cholesterol Roadmap

Global Real World EvidenceCholesterol and ASCVD

WHF Cholesterol Roadmap, México, September 19th 2018

ASCVD: Atherosclerotic Cardiovascular Disease

el CICPara Vivir Más y Mejor

Murphy A et al. Global Heart 2017el CICPara Vivir Más y Mejor

Objective 1:

. Analyse the strong evidence that support

the relationship between LDL-cholesterol

-LDL-C- and Atherosclerotic Cardiovascular Disease -ASCVD-.

Objective 2:

. Analyse the strong evidence that support

the relationship between LDL-C reduction and ASCVD prevention.

Objective 3:

. Stablish the rational and key steps

for the World Heart Federation Cholesterol Roadmap implementation in México.

Agenda:

1. What is cholesterol

2. What is the relationship LDL-C/ASCVD

3. What is the benefit of LDL-C reduction

4. What the US/EU Guidelines tell us5. What the WHF Cholesterol Roadmap tell us

Goldstein JL and Brown MS. Cell. 2015; 161:161-172el CICPara Vivir Más y Mejor

1. What is Cholesterol…

What is cholesterol 1/3

Cholesterol is a lipid essential for cell

integrity as steroid and bile acids

production. This lipid is synthetized for the

cells or acquired from lipoproteins though specific receptors vg., LDL and LDL-R.

Brown MS and Goldstein JL. Nobel Lecture 1985

Goldstein JL and Brown MS. Cell. 2015; 161:161-172el CIC

Para Vivir Más y Mejor

AcetylCoA

HMGCoA

Mevalonate Cholesterol

HMGCoARNucleous

SREBP2Chromosome 5

Cellular cholesterol synthesis

Membranes

ER-Golghi

What is Cholesterol

Hepatocyte

Nucleous

SREBP2Chromosome 19

LDL-C delivering and elimination

Membranes

ER-Golghi

Since the 70 s it is known that the LDL plasma

level required for delivering cholesterol to

cells is 25 mg/dl equivalent to 2.5mg/dl in the

interstitial space; the excess of LDL is accumulated in the subendothelial space.

D Reichl, N Myant, MS Brown and JL Goldstein

The Journal f Clinical Investigation. 1978;61:64-71

D Reichl, N Myant, MS Brown and JL Goldstein

The Journal f Clinical Investigation. 1978;61:64-71

LDL concentración mg/dL

5 10 15 20 25

Physiologic and Pathologic LDL level

What is Cholesterol

Response to LDL-Retention Model

What is Cholesterol

Tabas I et al. Circulation. 2007; 116:1832-1844

Goldstein JL and Brown MS. Cell. 2015; 161:161-172

Subendothelial infiltration and retention by matrix proteoglicans

LDL lipid oxidation an apo-B100 lysine modification

Modified LDL is

recognized as DAMP

and endocyted by

macrophages

scavenger receptors

The main mechanism to explain the LDL-C

increase is a quantitative and/or qualitative

defect in the hepatic LDL receptors. In the

current western society the “normal” LDL plasma level is in average 125-150 mg/dl.

Billheimer DW, Stone NJ, Grundy SM

J Clin Invest. 1979;64:524-533

Kovanen PT, Billheimer DW, Goldstein JL et al

Proc Natl Acad Sci USA. 1981;78:1194-1198

LDL production per day in mg/kg -VLDL-IDL-LDL-

15 15 15

LDL-C elimination FCR

1.6 0.8 0.4

LDL plasma

mg/dLLDL plasma

LDL plasma

Dog Chimpance Human

25 50 100

What is Cholesterol

Total-C

NoHDL-C

≥200 mg/dL

≥130 mg/dL

≥160 mg/dL

Carlos Aguilar-Salinas y cols. ENSANUT 2006

Hypercholesterolemia Prevalence in México

What is Cholesterol

2. What is the relationshipLDL-C/ASCVD…

What is the relationship LDL-C/ASCVD

There is an amazing basic, epidemiologic,

clinical and therapeutic evidence that

confirms the direct relation between the

cumulative LDL-C exposure and the burden of atherosclerotic plaque and ASCVD.

Anitshkow N and Chalatow S. Allg. Pathol. Anat. 1913; 24:1-9

Ference B et al. Eur Heart J. 2017; 38:2459-2472

What is the relationship LDL-C-ASCVD

Ference B et al. J Am Coll Cardiol. 2018; 70:1141-1157

10,000

20 y 40 y 60 y 80 y

LDL-C 125mg16%

Impact of LDL-C on ASCVD

5,000 1%Cumulative LDL-C Exposure ThresholdT

What is the relationship LDL-C-ASCVD

10,000

20 y 40 y 60 y 80 y

Impact of LDL-C on ASCVD

5,000 1%Cumulative LDL-C Exposure Threshold

LDL-C 200 vs 125 vs 80 mg/dL

3. What is the benefit of LDL-C reduction…

What is the benefit of LDL-C reduction

In the same way there is an amazing basic,

epidemiologic, genetic, clinical and

therapeutic evidence that confirms the

direct relation between LDL-C reduction and

burden of atherosclerotic plaque and ASCVD reduction.

Endo A et al. FEBS Lett. 1976; 72:323-326

What is benefit of LDL-C reduction

Moments for Cardiovascular Prevention

Enrique Morales-Villegas. Cardio Prevención Primaria

1ª Edición 2015. Editorial Atheros-CIC

Primordial Primary Secondary and Terciary

Kwiterovich PO et al. Lancet. 1973;i:118-122

Descamps OS et al. Atherosclerosis. 2004; 172:287-298

O Keefe JH Jr et al. J Am Coll Cardiol. 2004; 43:2142-2146

What is benefit of LDL-C reduction

Level of LDL-C in Humans

Physiologic level

Optimal level

“Normal” level

Genetic

Epigenetic

Ambiental

Others

10,000

20 y 40 y 60 y 80 y

Timing for LDL-C reduction in Humans

5,000 1%Cumulative LDL-C Exposure Threshold

LDL-C 125 mg/dL

For life vs for risk LDL-C reduction in Humans

1.00.90.80.70.60.50.4

0.78 -0.76 to 0.80-

RRR: 22% -20 to 24-

0.46 -0.41 to 0.52-

RRR: 54% -48 to 56-Genetic LDL-C Score

46 SNP, N = 376,443

Meta-Analysis of Statin RCTs

27 RCTs, N = 169,138

Ference BA , Majeed F, Panumetcha R et al.

J Am Coll Cardiol. 2015; 65:1552-1561

- 40mg

- 55% risk

- 40mg

- 20% risk

Timing for LDL-C reduction in Humans

4. What the

American/European Guidelines tell us…

1. Framingham 1998, 2001 and 20082. PROCAM 20023. Euro-SCORE 2003 4. QRISK 2007-20145. Reynolds women/men 2007/20086. WHO-ISH Charts 20077. INTERHEART 20118. ACC-AHA Pooled Cohort Equation 20139. Globorisk 2015

Morales-Villegas E.

In Preventive Cardiology. 1st Edition. Ruiz-Mori E Editor

What the Guidelines tell us

ASCVD Risk Estimation Algorithms

What American Guideline tell us

In primary prevention, up to now, ACC/AHA

Guideline recommends to reduce LDL-C

according with the estimated ASCVD risk*.

Healthy lifestyle and statins are the cornerstone to accomplish that goal.

Lloyd Jones DM et al. Lipid Pathway 2017. J Am Coll Cardiol.

* Pooled Cohort Equation AHA/ACC 2013

With Extra-Risk:. ASCVD risk ≥20%

. LDL-C ≥160 mg/dL

. ASCVD RF uncontrolled

. Familial history of ASCVD

. CKD with GFR <60 ml/min/1.73m2

. Lp(a) ≥50 mg/dL

. CRP ≥2 mg/L

. CCI ≥300 UA

. RA, SLE, etc

Without Extra-Risk

ASCVD Risk -PCE- ≥7.5%40 to 75 years

70 to 189 mg/dl LDL-C level

Moderate Intensity Statin for:

. LDL-C lowering ≥30% or

. LDL-C level <100 mg/dl

Ezetimibe/Resins

High Intensity Statin for:

Ezetimibe/Resins

What the American Guideline tell us

Lipid Pathway 2017

for Primary

Prevention in non

Diabetic Population

Lloyd Jones DM et al. Lipid Pathway 2017. J Am Coll Cardiol.el CICPara Vivir Más y Mejor

ASCVD Risk

≥7.5%

ASCVD Risk

Diabetes Mellitus40 to 75 years

70 to 189 mg/dl LDL-C level

Moderate Intensity Statin for:

. LDL-C level <100 mg/dl or

. Non-HDL-C <130 mg/dl

Ezetimibe/Resins

. Non-HDL-C <130 mg/dl

Ezetimibe/Resins

Lipid Pathway 2017

for Primary

Prevention in

Diabetic Population

In FH and in secondary ASCVD prevention,

AHA/ACC Guideline recommends to reduce

LDL-C without risk estimation.

Healthy lifestyle, statins and new non-statins

drugs -ezetimibe and Mabs-PCSK9-are the cornerstone to accomplish that goal.

Without

Severe Hypercholesterolemia

LDL-C >190 mg/dL20 to 75 years

Ezetimibe/Resins

Evolocumab/Alirocumab

Lomitapide/Mipomersen

Ezetimibe/Resins

Evolocumab/Alirocumab

Lomitapide/Mipomersen

Lipid Pathway 2017

for Severe

Hypercholesterole

With or Without Extra-Risk

Clinical ASCVD20 to 75 years

High Intensity or MTD Statin for:. LDL-C lowering ≥50% or

. Non-HDL-C level <100 mg/dl

If goal is not reached:

Ezetimibe: if goal gap is <20%

Evolocumab or Alirocumab: if goal gap is ≥20%

Lipid Pathway 2017

for ASCVD

Secondary

Prevention

What the European Guideline tell us

In ASCVD prevention, up to now, European

Guideline recommends to reduce LDL-C

according with the estimated ASCVD risk*.

Healthy lifestyle, statins and new non-statins

drugs are the cornerstone to accomplish that goal.

The Sixth Joint Task Force of the ESC and 10 more Societes

Eur Heart J. 2016; on line May 23, 2016

* SCORE algorithm

Very High Risk:. Clinical ASCVD

. Documented subclinical ASCVD

. DM with organ damage and/or other ASCVD RF

. CKD with GFR <30 ml/min/1.73m2

. ASCVD risk -SCORE- ≥10%

What the European Guideline tell us

The Sixth Joint Task Force of the ESC and 10 more Societies

Eur Heart J. 2016; on line May 23, 2016

LDL-C goal:. <70 mg/dl or

. LDL-C lowering ≥50%

If basal LDL-C level is

70-135 mg/dl.

High Risk:. Total cholesterol >310 mg/dl

. Blood pressure >180/110 mmHg

. DM without organ damage or other ACVD RF

. CKD with GFR 30 to 59 ml/min/1.73m2

. ASCVD risk -SCORE- 5 to <10%

LDL-C goal:. <100 mg/dl or

. LDL-C lowering ≥50%

If basal LDL-C level is

100-200 mg/dl.

Moderate Risk:. ASCVD risk -SCORE- 1 to <5%

Low Risk:. ASCVD risk -SCORE- <1%

LDL-C goal:. <115 mg/dl.

5. What the WHF Cholesterol

Roadmap tell us. The WHF Decalog.

Risk Based Approach to LDL-C

Cholesterol Roadmap

ASCVD Risk EstimationPrimary Health Care

Primary PreventionUse Risk Charts

Secondary PreventionRisk Charts not necessary

Familial Hypercholesterolemia

Source: WHF Cholesterol 2017el CICPara Vivir Más y Mejor

Murphy A et al. Global Heart 2017

Patient Pathway of

Cholesterol Treatment for Primary Prevention

Patient Pathway of

Cholesterol Treatment for Secondary Prevention

Patient Pathway of

Cholesterol Treatment

for Familial Hypercholesterolemia

The WHF Decalog

1.- Make Cholesterol a National Priority

Cholesterol Roadmap

• Make cholesterol a priority and listed

as a major condition within national

cardiovascular disease strategies.

2.- Increase public awareness

Cholesterol Roadmap

• Inform the public, health professionals,

journalists, policy makers, decision

makers… of the burden and ASCVD

risk of cholesterol.

3.- Training for Health Care Personnel

Cholesterol Roadmap

• All health care professionals who are in

contact with people at risk of ASCVD

should have access to training in risk

estimation, treatment and control of

hypercholesterolemia and ASCVD risk

according with Guidelines.

4.- Incentive for Performance

Cholesterol Roadmap

• Provide financial incentives to health

professionals responsible for risk

estimation, prevention, treatment and

control of hypercholesterolemia and

ASCVD risk.

5.- Deliver a patient-centered care

Cholesterol Roadmap

• Identify, support and promote a

nationally recognized pathway of care

for health care professionals.

6.- Monitoring and Follow up

Cholesterol Roadmap

• Identify and promote a clear management plan for

follow-up and adherence.

• Support patients to adhere to medications and

lifestyle changes.

• Identify the healthcare team responsible for

adherence including primary care and health

clinics professionals, pharmacists, community led

programs etc…

7.- Acces to Good Quality Medicine

Cholesterol Roadmap

• Governments should provide free or

subsidized good quality medication to

patients.

• Eliminate taxes on pharmaceuticals on

certain medications -efficient statins-.

8.- Invest in tools and resources

Cholesterol Roadmap

• Governments should invest in tools to

enable patients to self-manage their

cholesterol:

• Patient monitoring devices

• Phone applications (app)

• Reminders

9.- Investigate Gaps

Cholesterol Roadmap

• Health systems should identify existing

professional capacity to identify the gap

in practice, and provide targeted

training to health care professionals.

10.- Fight Poor Quality Medicines

Cholesterol Roadmap

• Health systems should identify and

erradicate poor quality medicines,

including “miracle” products and

alternative remedies.

Make Your Action Plan

Cholesterol Roadmap

• Step 1: Conduct your situational analysis to guide

your priority agenda.

• Step 2: Identify your 1-3 priorities:• What can be your greatest impact with minimum resources?

• What is your rational for change?

• Step 3: Follow a pathway to implementation:• Develop your action plan and project outline for

implementation.

• Make a commitment

Source: WHO. A Roadmap to Implementation Health 2020 – the Experience of San Marino

A situation analysis will inform you of current gaps and identify your priorities...

What is your specific focus? Your defined objectives? What do you hope to achieve?

Where will you begin? Will you pilot the programme in advance? What are the key stages of development? What resources do you

need to begin and to continue? human, financial, equipment & facilities? Who are your leadership

team? Do you have administrative support? How will you define and plan your goals? Who are your

stakeholders? What role will they have? How will you engage and maintain your relationships?How can you consolidate

and strengthen political will and buy in from stakeholders? How important is advocacy in your objectives?

How will you monitor and

evaluate your success?

el CIC WHF Cholesterol Roadmap, México ... - Academia El CIC 19 WHF CH… · Lp(a) ≥50 mg/dL....

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