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Argentine Society of LipidsArgentine Lipids Society Guidelines 2016
CV Risk guidelines for Argentina: What and how to follow?
Gerardo Damian Elikir
CV Risk Management 2017 Applying the latest insights to clinical care
Buenos Aires - Argentina April 8, 2017
Argentine Lipids Society Guidelines 2016
• Background
• Methodology
2
Clinical Practice Guidelines on Diagnosis and Treatment of Dyslipidemias in Adults 2016
Argentine Lipids Society Guidelines 2016
Authorship On behalf of Committee on Standards and Consensus
3
Argentine Lipids Society Guidelines 2016
1.Introduction 1.1.Methodology 1.2.Dyslipidemia and atherosclerosis
1.2.1.Atherosclerosis 1.2.2.Atherogenic lipoproteins: estimation through non-HDL-cholesterol 1.2.3.Low HDL-cholesterol 1.2.4.Triglycerides
2.Studies and diagnosis 2.1.The clinical laboratory in the diagnosis of dyslipidemia
2.1.1.Pre analytic variables 2.1.2.Analytic variables 2.1.3.Indices
2.2.Genetic studies 2.3.Risk stratification
3.Clinical Scenarios 3.1.Menopause 3.2.Secondary dyslipidemias
3.2.1.Hypothyroidism 3.2.2.Cholestasis 3.2.3.Drugs induced dyslipidemias
3.3.Renal disease 3.4.Metabolic syndrome and diabetes mellitus
3.4.1.Metabolic syndrome 3.4.2.Diabetes mellitus
3.5.Dyslipidemia in HIV patients 4.Treatment
4.1.General considerations 4.1.1.How long should lipid-lowering treatment be sustained? 4.1.2.Life-style modifications
4.2.Lipid-lowering drugs intolerance 4.2.1.Relevance of myopathies
4.3.Treatment of hypercholesterolemia 4.3.1.Statins 4.3.2.Ezetimibe 4.3.3.Combined treatment
4.4.Treatment of mixed hyperlipidemia and low HDL-c (“Residual risk”) 4.5.Treatment of severe hypertriglyceridemia
4.5.1.Omega-3 fatty acids 4.5.2.Fibrates 4.5.3.Niacin 4.5.4.Other therapeutic modalities
4.6.Treatment of altered HDL 4.7.Algoritms
5.Conclusions 6.Bibliography
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Contents
Argentine Lipids Society Guidelines 2016
• Lipoprotein metabolism
• Atherosclerosis
• Atherogenic lipoproteins: estimation through non-HDL-cholesterol
• Low HDL-cholesterol
• Pathogenic role for triglycerides
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1.2.Dyslipidemia and Atherosclerosis
Argentine Lipids Society Guidelines 2016
1. The clinical laboratory in the diagnosis of dyslipidemia
2. Genetic studies
3. Clinical assessment of cardiovascular risk
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2.Studios and diagnosis
Argentine Lipids Society Guidelines 2016
• Pre analytic variables
• Analytic variables
• Indices
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2.1. The clinical laboratory in the diagnosis of dyslipidemia
Argentine Lipids Society Guidelines 2016
• There are available several genetic scores for diagnosis and for prognostic
• Genetic studies are not recommended for estimating cardiovascular risk
• Genetic study would be reserved to confirm the clinical diagnosis of familial hypercholesterolemia (HF) in the index case and to facilitate the diagnosis of the relatives (cascade diagnosis)
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2.2. Genetic studies
Argentine Lipids Society Guidelines 2016
2.3. Clinical assessment of cardiovascular risk
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Intensity of interventions should be proportional to the total cardiovascular risk
WHO / ISH cardiovascular risk prediction chart Recommended by National Ministry of Health
Subregion WHO Member States
Region of the Americas
A Canada, Cuba, United States of America
B
Antigua and Barbuda, Argentina, Bahamas, Barbados, Belize, Brazil, Chile, Colombia, Costa Rica, Dominica, Dominican Republic,
El Salvador, Grenada, Guyana, Honduras, Jamaica, Mexico, Panama, Paraguay Saint Kitts and Nevis, Saint Lucia, Saint Vincent and the Grenadines, Suriname, Trinidad and Tobago, Uruguay, Venezuela
C Bolivia, Ecuador, Guatemala, Haiti, Nicaragua, Peru
WHO Member States by subregion, classified according to mortality stratum (based on World Health Report 2002 )
Prevention of Cardiovascular Disease: guidelines for assessment and management of total cardiovascular risk
WHO / ISH risk prediction chart for AMR B. 10-year risk of fatal or non-fatal cardiovascular event by gender, age, systolic blood pressure,
smoking status and presence or absence of diabetes mellitus
This chart can only be used for countries of the WHO Region of the Americas, sub-region B, in settings where blood cholesterol can be measured
CVD risk may be higher than indicated in the chart in people who are already on antihypertensive therapy, in women who have undergone premature menopause, in people approaching the next age category, and in individuals with any of the following: • obesity (including central obesity); • a sedentary lifestyle; • a family history of premature CHD or stroke in a first degree relative (male < 55 years, female < 65 years); • a raised triglyceride level (> 2.0 mmol/l or 180 mg/dl); • a low HDL cholesterol level (< 1 mmol/l or 40mg/dl in males, < 1.3 mmol/l or 50 mg/dl in females); • raised levels of C-reactive protein, fibrinogen, homocysteine, apolipoprotein B or Lp(a), or fasting glycaemia, or impaired glucose tolerance; • microalbuminuria (increases the 5-year risk of diabetics by about 5%) (38, 83, 85); • those who are not yet diabetic, but have impaired fasting glycemia or impaired glucose tolerance; • a raised pulse rate.
Other risk factors not included in these risk prediction charts such as socioeconomic deprivation and ethnicity should also be taken unto account in addressing and managing a person’s overall CVD risk.
Prevention of Cardiovascular Disease: guidelines for assessment and management of total cardiovascular risk
WHO / ISH risk prediction chart for AMR B. 10-year risk of fatal or non-fatal cardiovascular event by gender, age, systolic blood pressure,
smoking status and presence or absence of diabetes mellitus
This chart can only be used for countries of the WHO Region of the Americas, sub-region B, in settings where blood cholesterol CANNOT be measured
Prevention of Cardiovascular Disease: guidelines for assessment and management of total cardiovascular risk
Argentine Lipids Society Guidelines 2016
2.3. Clinical assessment of cardiovascular risk
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High risk conditions Disease specific Subclinical atherosclerosis ASCVD
• LDL ≥190 mg/dL (4.9 mmol/L) • Chronic renal disease • Inflammatory diseases (RA,
SLE, PSO) • Cancer survivors • Transplant recipients • Metabolic syndrome
Hypoalfalipoproteinemia • Lp(a) >50 mg/dL (>75 nmol/L)
• Familial Hypercholesterolemia • Diabetes Mellitus
Evidence of atherosclerosis by: • Coronary angiography • Non-invasive imaging • Coronary calcium score • Altered myocardial perfusion • Ankle brachial index
• Angina pectoris • Coronary heart disease • Myocardial infarction • Transient ischaemic attacks • Stroke (from AS origin) • Peripheral vascular disease • Coronary revascularization • Carotid endarterectomy
When can treatment decisions be made without the use of risk prediction
charts?
Argentine Lipids Society Guidelines 2016
1. Menopause
2. Secondary dyslipidemias
1. Hypothyroidism
2. Cholestasis
3. Drugs induced dyslipidemias
3. Renal disease
4. Metabolic syndrome and diabetes mellitus
5. Dyslipidemia in HIV patients
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3. Clinical scenarios
Argentine Lipids Society Guidelines 2016
• Estrogens have beneficial effects on the lipid profile
• Menopause is associated with increased cardiovascular risk
• In post menopausal women: • Clinical assessment of CVD risk • Treat concomitant conditions (DYS, HBP, T2DM) • HRT: women 50-59 years-old w/menopause <10
years
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3.1. Menopause
Argentine Lipids Society Guidelines 2016
1. Hypothyroidism • Very frequent cause of dyslipidemia • Treatment is controversial
2. Cholestasis • Treat the cause (autoinmune hepatitis, primary biliar
cirrosis, vanishing bile duct syndrome) • Statins are not contraindicated
3. Drugs induced dyslipidemias • Interactions FK / FD
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3.2. Secondary dyslipidemias
Argentine Lipids Society Guidelines 2016
• High risk condition with specific alterations on lipids • “Conventional” risk factors are very common • “Specific” risk factors can worse the prognosis:
calcium-phosphorus metabolism, nutrition, anemia
• Statins should start before renal replacement therapy
• Adjust doses to renal function (e.g. fibrates)
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3.3. Chronic kidney disease
Argentine Lipids Society Guidelines 2016
• Metabolic syndrome identifies high risk subjects. Independent contribution of each component is controversial
• Abdominal obesity is defined using regional cut points (IDF):
• ♀80cm; ♂ 94cm
• Glycemic control contribute to improve lipoprotein alterations and lipid-lowering treatment is key to reduce high risk on T2DM patients
• Consider absolute risk: • <40 years and recent DM: no statins • > 40 years without risk factors: moderate efficacy statins • > 40 years with risk factors: high efficacy statins
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3.4. Diabetes, metabolic syndrome and obesity
Argentine Lipids Society Guidelines 2016
• Lipid profile varies according stage of HIV infection and treatment
• Similar approach to dyslipidemias than general population. Drug interactions is an issue
• Consider changing on antiretroviral therapy before starting lipid-lowering drugs (if suitable!)
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3.5. Human immunodeficiency virus infection
Argentine Lipids Society Guidelines 2016
• How long should treatment be sustained?
• Therapeutic life-style modifications
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4. Treatment: general considerations
Argentine Lipids Society Guidelines 2016
• Exercise regimented + daily walking
• Smoking cessation
• Healthy dietetic pattern • Increased fresh fruit and vegetables intake • Dietary fiber • Reduction of sugar and refined carbohydrates intake (“Nothing white”)
• Weight reduction
• Functional foods
• Psychosocial factors control (depression, stress, social isolation, rage)
• Controlling additional risk factors (other than DYS): HBP, T2DM
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STEP 1: therapeutic life-style modifications and risk factors control
<20%
Treatment
Specific treatment
STEP 1: Therapeutic life-style modifications and risk factors control
>20%
<40 years
Therapeutic life-style modifications
>40 years
Moderate efficacy statins
High efficacy statins
High risk conditions
Diabetes mellitus Familiar hypercholesterolemia
>75 years <75 years
Subclinical Ath
STEP 4: Clinical assessment of CVD risk (Risk chart)
STEP 2: Secondary dyslipidemia
STEP 3: Triglycerides >500 mg/dL
ASCVD
c-LDL >50c-LDL >70c-LDL >100
Statins intolerance ? —> See below
Add Ezetimibe / Cholestyramine
Novel drugs
Add Fenofibrate (if high TG / low HDL-c)
Argentine Lipids Society Guidelines 2016
Hypertriglyceridemia
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Severe and refractory: consider genetic forms of hypertriglyceridemia
Inpatient treatment: consider insulin, heparin y aphaeresis
Novel drugs
• Diabetes • Alcohol intake • Apo E phenotype (E2/E2) • Overweight • Drugs / oral contraceptives
Exercise Weight reduction 5-10%
Reduce refined carbohydrates intake Avoid alcohol intake
Hypotriglyceridemic agents
Mild - moderate: mostly secondary
• Primary monogenic LPL deficiency • Secondary monogenic LPL deficiency
(apoC2, apoA5, GPIHBP1, LMF1)
Argentine Lipids Society Guidelines 2016
HDL modifications
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Low HDL-c
Triglycerides >200 mg/dL
See figure 1
Statins
High HDL-c
ASCVD Asymptomatic
Disfunctional HDL
Normal triglyceride levels
?
Control
StatinsFibratesNiacin
Hypoalfalipoproteinemia
See figure 2
Novel drugs (iCETP?)
Argentine Lipids Society Guidelines 2016
Management of statin-associated myopathy
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Asimptomatic
• Not CPK monitoring is required, except in patients with high risk of myopathy* • CPK elevations
• CPK <3 ULN: continue • CPK 3-10 ULN: symptoms assessment and repeat CPK measurement • CPK >10 ULN: stop statin, search causes y predisposing factors (vitD deficiency, electrolyte disturbances, hypothyroidism). Consider risk / benefit ratio
to treatment continuation
Simptomatic
• Tolerable • Search causes y predisposing factors (vitD deficiency, electrolyte disturbances, hypothyroidism) • Dechallenge - re challenge test (to adjudicate causality) • Change statin • Coenzime Q10 supplementation
• Intolerable • Stop statin, down titration, alterne days regime, to máximum tolerable statin doses. Add second cholesterol-lowering drug to attain LDL goal • Confirm statin intolerance (two different statins), if risk is acceptable
Statin Intolerance
• Use of non-statin drugs (mono therapy or combination): • Ezetimibe • Cholestyramine • Niacin • Plant sterols • Red yeast rice (Oryza sativa)
Guideline Strenghts / advantages Weakness Scope
Polish 2016 Evidence-based recommendations Local adapted ESC Guidelines
Local data lackness Dyslipidemia
Argentine Lipids Society 2016
Practice guidelines case-based Integrative approach (goals / fixed dosis)
Spanish
Validation? Implementation issues Dyslipidemia
ESC / EAS 2016 “Traditional” approach (goals-based) Local data lackness CV prevention
Argentine Society of Cardiology 2015
Based on local data Spanish
Just a re-elaboration of foreign guidelines
CV prevention
AHA / ASA 2014Evidence-based recommendations
Simplicity Wide scope of risk factors
Does not adequately consider other dyslipemias other than CT Secondary prevention
AHA / ACC 2013
Evidence-based recommendations Simplicity
Novel (and rational) approach (benefit groups identified)
Hispanic population not included Does not adequately consider other
dyslipemias other than CT Some inusual recommendations
Hypercholesterolemia Secondary prevention
Joint Argentine Societies of
Cardiology 2012
Based on local data Spanish Update needed CV prevention
AHA / ASA 2011Evidence-based recommendations
Simplicity Wide scope of risk factors
Does not adequately consider other dyslipemias other than CT
Stroke prevention
Ministry of Health 2012
(WHO 2003/2007)
Affordability addressed Based on local data
Spanish
Does not adequately consider other dyslipemias other than CT
Update needed
CV prevention (Population approach)
ATPIII 2001Broad dissemination and acceptance
Wide scope of risk factors Introduce Metabolic syndrome
Evidence does not support most recommendations
Dyslipidemia (focus on LDL-c)
We looking forward on September…
14 y 15 de septiembre de 2017 Buenos Aires | Argentina
www.lipidos.org.ar
XIV Reunión Científica Anual I Encuentro internacional SAL - IAS
Argentine Lipids Society Guidelines 2016
Paso 2: descartar dislipemias secundarias y dar tratamiento específico
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Argentine Lipids Society Guidelines 2016
Fármacos hipotrigliceridemiantes
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Dosis y eficacia de los hipotrigliceridemiantes
Grupo Fármaco Dosis diaria Eficacia
Fibratos
Clofibrato (en desuso)GemfibrozilBezafibratoCiprofibratoFenofibrato
Ácido fenofíbrico
500 mg600 - 1200 mg
400 mg100 mg
100 - 350 mg45 - 135 mg
20 - 50%
Ácidos grasos omega-3EPA
DHA + EPA900 - 1800 mg
2 - 4 g25 - 45%
NiacinaLiberación inmediataLiberación extendida
750 - 3000 mg500 - 2000 mg 20 - 40%
EPA: ácido eicosapentaenoico; DHA: ácido docosahexaenoico
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