2. AIMS OF PRESENTATION
• 2013 ACC/AHA Guidelines
• 2016 ACC Expert Consensus decision pathway
• Lipid Association of India Expert Consensus Statement on
management of dyslipidemia in Indians 2016
3. INTRODUCTION
• CVD : single largest cause of death developed countries
• Leading cause of death and disability in developing countries
• Younger age in India
• Dyslipidaemia : common modifiable and easily controllable
risk factor
4.
5. ACC/AHA 2013 GUIDELINES
• Focused on RCT related evidence
• Proven therapy rather than arbitrary lipid targets
• “Net ASCVD risk-reduction benefit of statins”
6. LIFESTYLE
• Heart – healthy lifestyle should be encouraged for all
• Dietery approaches to Stop Hypertension (DASH) or
Mediterranean style diet ( rich in vegetables, fruits, whole
grains, poultry etc)
• Regular exercise habits
• Avoidance of tobacco products
• Maintenance of a healthy weight
7. FOUR MAJOR STATIN BENEFIT GROUPS
• Individuals with clinical ASCVD
• Individuals with LDL >190mg/dl
• Individuals with DM, 40-75 y with LDL level 70-189mg/dl
and without clinical ASCVD
• Individuals without clinical ASCVD or DM with LDL
70-189mg/dl and estimated 10-year ASCVD risk >7.5%
10. HIGH- MODERATE- AND LOW-INTENSITY STATIN THERAPY
High-Intensity Statin
Therapy
Moderate-Intensity Statin
Therapy
Low-Intensity Statin
Therapy
Daily dose lowers LDL–C on
average, by approximately
≥50%
Daily dose lowers LDL–C on
average, by approximately
30% to <50%
Daily dose lowers LDL–C on
average, by <30%
Atorvastatin 40–80 mg
Rosuvastatin 20 - 40 mg
Atorvastatin 10 – 20 mg
Rosuvastatin 5 – 10 mg
Simvastatin 20–40 mg
Pravastatin 40 – 80 mg
Lovastatin 40 mg
Fluvastatin XL 80 mg
Fluvastatin 40 mg bid
Pitavastatin 2–4 mg
Simvastatin 10 mg
Pravastatin 10–20 mg
Lovastatin 20 mg
Fluvastatin 20–40 mg
Pitavastatin 1 mg
11. FOLLOWUP
• Assess adherence, response to therapy, adverse effects with in 4 –
12 weeks following statin initiation or change in therapy
• Anticipated response : apprx. > 50% reduction in LDL from baseline
with high intensity and 30 – 50 % reduction with moderate
intensity statin
• Less response : ↑ dose, add non statin therapy in selected high risk
individuals
• Intolerant to statin : Use maximally tolerated dose
• Baseline LFT
• CK if muscle symptoms
• Two LDL values < 40 mg/dl, can consider dose reduction
• New onset type 2 diabetes mellitus
12. LIMITATIONS
• No targets may reduce compliance
• Over treatment for primary primary prevention
• Clinician judgement for whom RCT evidence is insufficient
• No guidelines on addition of other lipid lowering drugs
13.
14. OBJECTIVES
• Patient populations for consideration of non-statin therapy
• Situations for consideration of non-statin therapy
• Treatment options for patients who are truly statin intolerant
• If non-statin therapies are to be added, which agents or
therapies should be considered and in what order
15.
16. ≥ 21 yrs
Stable ASCVD
No comorbidities
• Optional Non Statin :
Ezetemibe first/ BAS if
intolerance to
Ezetemibe
• Consider adding/
replacing with PCSK9
inhibitor second
• LDL target < 100 mg/dl
17. Clinical ASCVD with comorbidity
• Diabetes
• Recent (<3 months) ASCVD event
• ASCVD event while already taking a statin
• Poorly controlled other major ASCVD risk factors
• CKD not on hemodialysis
18. ≥ 21 yrs
Stable ASCVD
Comorbidities present
• Optional Non
Statin :
Ezetemibe first/
BAS if intolerance
to Ezetemibe
• Consider adding/
replacing with
PCSK9 inhibitor
second
• LDL target
< 70 mg/dl,
• Non HDL
< 100 mg/dl
19. ≥ 21 yrs
Clinical ASCVD
Base line LDL ≥ 190
mg/dl
No Secondary cause
• Optional Non Statin
: Ezetemibe / BAS
second line
• Consider PCSK9
inhibitor
• LDL target < 70
mg/dl
• Consider referral to
lipid specialist and
Nutritionist
20. ≥ 21 yrs
No Clinical ASCVD
Base line LDL ≥ 190
mg/dl
No Secondry cause
• Optional Non
Statin :
Ezetemibe /
BAS second line
• Consider PCSK9
inhibitor
• LDL target <
100 mg/dl
• Consider
referral to lipid
specialist and
Nutritionist
21. Age 40 – 75y
No Clinical ASCVD
Base line LDL
< 70 - 189 mg/dl
Diabetes
• Optional Non Statin :
Ezetemibe
• BAS second line
• No PCSK9 inhibitor
• LDL target < 100
mg/dl, Non HDL <
130 mg/dl
22. Age 40 – 75y
No Clinical ASCVD
Base line LDL
< 70 - 189 mg/dl
No Diabetes
• Optional Non
Statin :
Ezetemibe / BAS
second line
• No PCSK9
inhibitor
• LDL target < 100
mg/dl
23. Lipid Association of India:
Expert Consensus Statement on Management
of Dyslipidemia in Indians 2016
24. INDIAN VS WESTERN
• Indians at high risk of developing ASCVD
• Get the disease at an early age
• Have a more severe form of the disease
• Poorer outcome as compared to the western populations
• Access to health care is also not optimal in India
• Treatment of ASCVD expensive
25. DYSLIPIDAEMIA IN INDIA
• The prevalence is constantly increasing in Indians
• 10-15% in rural to 25-30% in urban populations
• Younger age
• Higher TG and lower HDL
• Lower total and LDL Cholesterol
• Atherogenic dyslipidemia
• Low BMI – moderate dose may suffice to decrease LDL by 50%
• Statin induced risk of DM
27. Pre-existing ASCVD
• H/o MI or documented CAD
• History of Stroke/ TIA/
hemodynamically significant
carotid plaque
• PAD (includes ankle-brachial
index <0.9)
• Atherosclerotic aortic
aneurysms
• Atherosclerotic Renal Artery
Stenosis
28. Major ASCVD Risk
• Age : ≥45y males
≥55 y in females
• Family history of early ASCVD
(<55 y in a male first degree
relative or <65 y of age in a
female first-degree relative)
• Current cigarette smoking or
tobacco use
• High blood pressure (≥140/90
mm Hg or on blood pressure
medication)
• Low HDL-C (males <40 mg/dL
and females <50 mg/dL)
30. VERY HIGH RISK
• Pre-existing ASCVD
• Diabetes with
- evidence of end organ damage
- >2 other major ASCVD risk factors
• Familial homozygous hypercholesterolemia
31. HIGH RISK
• No Diabetes, ≥3 major ASCVD risk factors
• Diabetes with 0-1 other major ASCVD risk factors
and no evidence of end organ damage
• CKD stage 3B or 4
• Familial hypercholesterolemia (other than familial
homozygous hypercholesterolemia)
• Extreme of a single risk factor
e.g. LDL-C >190 mg/dL, strong family history of premature ASCVD, heavy smoker
32. Non conventional risk markers : High Risk
• CAC score >300 Agatston units
• Non-stenotic carotid plaque
• Lp(a) >50 mg/dL
35. LOW RISK
• 0-1 major ASCVD risk factors
• Assess lifetime ASCVD in these patients
• www.jbs3risk.com
• If ≥ 30% consider as moderate risk group
36.
37. LDL CHOLESTROL
• Lower the Better
• More aggressive lowering of LDL-C level to 50 mg/dL or less -
significant reduction in atheroma volume and CV events
• No ↑ risk of cancer, hemorrhagic stroke, non-CV death or
neurocognitive dysfunction with very low LDL-C levels
38. NON HDL CHOLESTROL
• Non HDL Cholestrol = Total Cholestrol – LDL Cholestrol
• Non-HDL-C as a co-primary target, as important as LDL-C, for
lipid lowering therapy in Indians
39. GOALS IN INDIAN CONTEXT
Risk Category Treatment Goal Consider Drug Therapy
LDL Cholestrol
(mg/dl)
Non HDL Cholestrol
(mg/dl)
LDL Cholestrol
(mg/dl)
Non HDL Cholestrol
(mg/dl)
Very High Risk < 50 <80 ≥ 50 ≥ 80
High Risk <70 <100 ≥ 70 ≥ 100
Moderate
Risk
<100 <130 ≥ 100 ≥ 130
Low Risk <100 <130 ≥ 130* ≥ 160*
* After an adequate initial non pharmacological intervention of 3 months
Non HDL within 30 mg/dl of LDL Cholestrol
Journal of The Association of Physicians of India March
2016 supplement
40. HYPERTRIGLYCERIDEMIA
• Reversible causes : Treat
• Lifestyle Modification for all :
Regular exercise
Maintenance of proper body weight
Avoidance of alcohol
Diet with reduced saturated fat and refined carbohydrates
• TG < 500 mg/dL : Statins
• First achieve LDL-C target
• If TG is still > 200mg/dL calculate non-HDL-C level, if above
goal, add a non-statin drug to achieve the non-HDL-C goal
41. HYPERTRIGLYCERIDEMIA
• Keep TG <150 mg/dL, preferably <100mg/dL.
• If TG > 500mg/dL:
Objective - reduce the risk of pancreatitis
Start with a non-statin drug
Add statin to achieve LDL-C and Non HDL-C goals
• Fibrates
• High dose omega-3 fatty acids
42. LOW HDL CHOLESTROL
• Independent risk factor for ASCVD
• Statins raise HDL-C levels by 5% to 15%
• Recommended to increase HDL even if LDL is normal/ low
• Niacin not recommended
• If TG also high, fibrates can be added
43. PRIMARY PREVENTION
• Screen for ASCVD all adults at 20 years of age/college entry
• Assess ASCVD risk and discuss the health program
• Follow the “ magnificent seven”
45. THERAPEUTIC LIFESTYLE
Physical Activity :
• Avoid inactivity
• For substantial benefit 150 m/week moderate intensity , or 75
m/week of vigorous-intensity aerobic physical activity
• Performed in episodes of at least 10 minutes, and preferably,
it should be spread throughout the week
• For additional and more extensive health benefits, increase
aerobic physical activity to 300 m/week of moderate-intensity,
or 150 m/week of vigorous-intensity aerobic physical activity
• Muscle strengthening activities
46. THERAPEUTIC LIFESTYLE
Diet :
• Dietary pattern that emphasizes intake of vegetables, fruits,
whole grains, low-fat dairy products, poultry, fish, legumes,
non tropical vegetable oils, nuts, etc
• Limit intake of sweets, sugar sweetened beverages, and red
meat
47.
48. Alcohol :
• Alcohol intake should preferably be avoided
• For patients who drink, alcohol should not exceed 1 drink
per day for women or up to 2 drinks per day for men
Tobacco :
• Complete Abstinence
Stress Management :
• Yoga
• Meditation
THERAPEUTIC LIFESTYLE
This is the new equation, the pooled cohort risk assessment equation
As you can see, there are different parameters that you need to plug in to the equation to calculate the risk: gender, age, race, total cholesterol, HDL, systolic BP, whether or not you are on any anti-HTN meds, any history of DM or being a smoker
