dyslipdemia guidelines head to head
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DYSLIPIDEMIA
CLINICAL GUIDELINES UPDATE
DR. MOHAMMAD DAOUDCONSULTANT ENDOCRINOLOGIST
KAMC-NGHA JEDDAH
THE AGENDA…
INTRODUCTION
RISK ASSESSMENT TOOLS
GUIDELINES : HEAD TO HEAD
MANAGEMENT : STATINS +/-
CONCLUSION
CARDIOVASCULAR DISEASE (CVD)
(CVD) = Disease of the heart and blood vessels caused by the process of atherosclerosis; Includes CHD; ACS/Angina, TIA/Stroke and PAD
The leading cause of death in many countries with significant cost implications
Though mortality from CVD is falling but morbidity appears to be rising
CARDIOVASCULAR DISEASE (CVD)
(CVD) predominantly affects people older than 50 years
Risk factors
Non-modifiable
AgeSex
Family history of CVDEthnic background
ModifiableSmoking
HTNDyslipidemia
DMSocial : Low income
and social deprivation
WHERE WE ARE WE NOW?FROM ….TO
Risk stratification based on Five major steps.
- Obtain Fasting Lipid profile- Identify CHD risk equivalents- Identify CHD risk factors- Calculate 10 year risk of CHD using Framingham risk score- Determine the risk category and goals of therapy.
NCEP ATP III GUIDELINES FOR RISK ASSESSMENT
1.Diabetes Mellitus
2.Symptomatic Carotid Artery Disease
3.Peripheral Arterial Disease
4.Abdominal Aortic Aneurysm
5.CRF with Cr > 1.5 or GFR< 60
6.Multiple risk factors with a 10 year risk of CHD> 20%
CHD RISK EQUIVALENTS
ATP III MAJOR CHD RISK FACTORS OTHER THAN LDL-C
• Cigarette smoking• Hypertension: BP 140/90 mm Hg or on antihypertensive
medication• Low HDL-C: 40 mg/dL (1.03mmol/L)*• Family history of premature CHD (1st-degree relative):
• Male relative age 55 years• Female relative age 65 years
• Age -Male 45 years
-Female 55 years
HDL-C 60 mg/dL (1.55mmol/L) = negative risk factor; Delete one risk factor.
ATP III: Updated LDL-C Goals, Treatment Cut-Points
Grundy SM et al. Circulation. 2004;110:227-239.
<130 mg/dL(optional:<100 mg/dL)
<100 mg/dL(optional:<70 mg/dL)†
LDL-C Goal
130 mg/dL(100–129 mg/dL: consider drug options)
130 mg/dL‡Moderatelyhigh risk:2 risk factors(10-year risk 10%–20%)
100 mg/dL(<100 mg/dL: consider drug options)
100 mg/dL‡High risk:CHD or CHD risk equivalents*
(10-year risk >20%)
ConsiderDrug TherapyInitiate TLCRisk Category
*CHD risk equivalents: clinical manifestations of noncoronary forms of atherosclerotic disease (transient ischemic attacks or stroke of carotid origin >50% obstruction of a carotid artery), diabetes, and 2 risk factors with 10-year risk >20% for hard CHD.
†The optional LDL-C goal of <70 mg/dL is favored in those at very high risk (e.g., people with diabetes, smokers) as well as those with metabolic syndrome, acute coronary syndrome, high TG, and/or non–HDL-C <100 mg/dL.
‡Any person at high or moderately high risk with lifestyle-related risk factors is a candidate for TLC to modify these risk factors regardless of LDL-C level.
ATP III: Updated LDL-C Goals, Treatment Cutpoints (cont’d)
Grundy SM et al. Circulation. 2004;110:227-239.
Risk Category LDL-C Goal Initiate TLCConsiderDrug Therapy
Moderate risk: 2 risk factors(10-year risk <10%)
<130 mg/dL 130 mg/dL 160 mg/dL
Lower risk:0–1 risk factor
<160 mg/dL 160 mg/dL 190 mg/dL(160–189 mg/dL:LDL-C–lowering drug optional)
Not modified in update
WHAT’S NEW ?
LIPIDS ADA 2014… WAS
To get specified LDL target Statin therapy should be added, regardless of baseline
lipid levels, for DM patients:- With overt CVD
-Without CVD who is > 40 years old and have ≥ 1 other CVD risk factors. (A)
An alternative therapeutic goal : Reduction in LDL cholesterol by 30–40% from baseline
(A)
Statins use is based on desired LDL-C Intensity lowering rather than LDL target number
Adjustment of intensity of statin therapy may be needed based on individual patient response to medication
(e.g., side effects, tolerability, LDL cholesterol levels). E
LIPIDS ADA 2015
LIPIDS ADA 2014… WAS
If targets are not reached; Use combination therapy
No outcome studies; CVD outcomes or safety.
(E)
Combination therapy(statin/ fibrate and statin/niacin)
has not been shown to provide additional cardiovascular benefit above statin therapy alone
and is Not generally recommended
A
LIPIDS ADA 2015
2013 ACC/AHA GUIDELINES ON TREATMENT OF
BLOOD CHOLESTEROL TO REDUCE ATHEROSCLEROTIC CARDIOVASCULAR RISK IN
ADULTS
NICE CLINICAL GUIDELINE 181GUIDANCE.NICE.ORG.UK/CG181
NICE 2014
An update of existing National Institute for Health and Care Excellence (NICE) guidance (published in 2008)
STATINS INTENSITY CATEGORIES NICE VS ACC/AHA
NICE
low intensity 20% to 30%
medium intensity 31% to 40%
high intensity > 40%
ACC/AHA
low intensity <30%
medium intensity 30% to <50%
high intensity ≥ 50%
Targeting LDL Targeting non-HDL
LIPIDS ADA 2014… WAS
An alternative therapeutic goal : Reduction in LDL cholesterol by
30–40% from baseline (A)
STATINS INTENSITY CATEGORIES OF LOWERING LDL –C NICE VS ACC/AHA
NICE - DYSLIPIDEMIA AND (CVD) STATINS INTENSITY
Modest potency statins
Rosuvastatin 5-10 mgAtorvastatin :10-20 mg Simvastatin : 20-40 mgFluvastatin -XL : 80 mg
High potency statins
Rosuvastatin 20-40 mg
Atorvastatin :40-80 mg
2013 ACC/AHA GUIDELINES ON TREATMENT OF
BLOOD CHOLESTEROL TO REDUCE ATHEROSCLEROTIC CARDIOVASCULAR RISK IN
ADULTS
≥ 7.5% ASCVD 10-years Risk
Download from : Google Play Store Search for : ASCVD Risk
Link: Calculatorhttps://play.google.com/store/apps/details?id=org.acc.cvrisk
NICE CLINICAL GUIDELINE 181GUIDANCE.NICE.ORG.UK/CG181
NICELIPID MODIFICATION
CARDIOVASCULAR RISK ASSESSMENT AND THE MODIFICATION OF BLOOD LIPIDS FOR THE PRIMARY AND SECONDARY PREVENTION OF CARDIOVASCULAR DISEASE
ISSUED: JULY 2014 LAST MODIFIED: SEPTEMBER 2014
NICE GUIDELINES-2014 DYSLIPIDEMIA AND (CVD)
Do not use a risk assessment tool for people
1-With pre-existing CVD
2-Familial hyper-cholesterolemia
3- With type 1 DM
4-With CKD ; e GFR < 60 ml/min/1.73 m2 and/or albuminuria
NICE GUIDELINES -DYSLIPIDEMIA AND (CVD)
IDENTIFYING AND ASSESSING (CVD) RISK
Use the QRISK2 risk assessment tool to assess CVD risk for the primary prevention of CVD in people (including type 2 DM)
older than 40 up to and including age 84 years (review on regular basis)
QRISK2 cannot be used in people over 84 years of age.
NICE GUIDELINES -DYSLIPIDEMIA AND (CVD)
IDENTIFYING PEOPLE FOR FULL FORMAL RISK ASSESSMENTDIABETIC PATIENTS
The QRISK2 risk assessment tool
Calculator is available at
http://www.qrisk.org
Exclude common secondary causes of dyslipidemia before referral
(Ex:excess alcohol, uncontrolled DM, hypothyroidism, liver disease and nephrotic syndrome)
DYSLIPIDEMIA AND (CVD)
Include all of the following in the assessment:-Smoking status -Alcohol consumption-Blood pressure-Body mass index or other measure of obesity
-Total-C, HDL-C, non-HDL-C and triglycerides-HbA1c-Renal function and e-GFR-Transaminase level (ALT , AST )-TSH
NICE : LIPID MODIFICATION THERAPY FOR THE PRIMARY AND SECONDARY PREVENTION OF CVD
Lipid measurement and referral
A fasting sample is not needed
Measure a full lipid profile (Total-C , HDL – C , TAG ) and (non-HDL-C ) to achieve the best estimate of CVD risk
Clinical findingsLipid profile
Family history =The likelihood of a familial lipid disorder
NICE : LIPID MODIFICATION THERAPY FOR THE PRIMARY AND SECONDARY PREVENTION OF CVD
Lipid measurement and referral
Consider Familial hyper- cholesterolemia and investigate if they have:
1-Total-C > 7.5 mmol/L and2- Family history of premature CHD
Definite MI or sudden death affecting a first degree relative before age of 55 yrs (males) or 65 yrs (females)
NICE : LIPID MODIFICATION THERAPY FOR THE PRIMARY AND SECONDARY PREVENTION OF CVD
Lipid measurement and referral
Arrange for specialist assessment if Total –C > 9.0 mmol/L or a non-HDL C > 7.5 mmol/L
even in the absence of a first-degree F.Hx of premature CHD disease
Refer for urgent specialist review if a person has a triglyceride concentration of > 20 mmol/L (Exclude excess alcohol or poor glycemic control)
DYSLIPIDEMIA AND (CVD) PHARMACOLOGIC THERAPY FOR THE
PRIMARY AND SECONDARY PREVENTION OF CVD
Use drugs with evidence in clinical trials of a beneficial effect on CVD morbidity and
mortality
When a decision is made to prescribe a statin use a statin of high intensity and low acquisition cost
NICE GUIDELINES -DYSLIPIDEMIA AND (CVD)STARTING A STATIN
Decide after an informed discussion and assure patient’s knowledge about Pros/ Cons
=Individualized care
Stress the importance of TLC and consider the patient preferences, Co-morbidities,
poly-pharmacy, general frailty, and life Expectancy
LIPIDSRX RECOMMENDATIONS AND GOALS
Lifestyle modification (TLC) has been shown to Improve the lipid profile in patients with diabetes.
(A)
This include:- Reduction of saturated fat, trans fat, and cholesterol intake -Increase of n-3 fatty acids, viscous fiber and plant stanols / sterols
-Weight loss (if indicated); and increased physical activity
NICE GUIDELINES -DYSLIPIDEMIA AND (CVD)
SECONDARY PREVENTION OF CVD
-Start statin Rx in people with CVD with Atorvastatin 80 mg (or equivalent)
Use a lower dose of atorvastatin if any of the following apply: Potential drug interactions High risk of adverse effects Patient preference
Do not delay statin in secondary prevention to manage modifiable risk factors Ex : Person has ACS
NICE GUIDELINES -DYSLIPIDEMIA AND (CVD)
PRIMARY PREVENTION OF CVD-Estimate the level of risk using the QRISK2 (when indicated)
-Exclude secondary causes
Offer Atorvastatin 20 mg for the primary prevention of CVD to people who have a ≥ 10% (10-year) risk of developing CVD (estimated with QRISK2 ).
NICE GUIDELINES -DYSLIPIDEMIA AND (CVD)
PRIMARY PREVENTION FOR PEOPLE WITH TYPE 2 DM
Offer Atorvastatin 20 mg for the primary prevention of CVD to people with type 2 DM who have a ≥ 10% (10-year) risk of developing CVD
Estimate the level of risk using the QRISK2 assessment tool
NICE GUIDELINES -DYSLIPIDEMIA AND (CVD)
PRIMARY PREVENTION FOR PEOPLE WITH TYPE 1 DM
Offer statin treatment for the primary prevention of CVD to adults with type 1 DM who:
1- Are older than 40 years or have had DM for > 10 years or2- Have established nephropathy or have other CVD risk factors.
>>>>>>
Treat adults with type 1 DM with Atorvastatin 20 mg
NICE GUIDELINES -DYSLIPIDEMIA AND (CVD)
PREVENTION OF CVD TO PEOPLE WITH CKD
Offer Atorvastatin 20 mg for the primary or secondary prevention of CVD to people with CKD
Increase the dose if a > 40% reduction in non-HDL cholesterol is not achieved and (e GFR ) is ≥ 30 ml/min/1.73 m2
Agree the use of higher doses with a renal specialist if e GFR is < 30 ml/min/ 1.73 m2.
DYSLIPIDEMIA AND (CVD)
STATINS EFFICACY , SAFETY , TOLERABILITY
DYSLIPIDEMIA AND (CVD)FOLLOW-UP OF PEOPLE STARTED ON STATIN TREATMENT
Measure Total-C, HDL-C and non-HDL-C in all people who have been started on high-intensity Statin treatment at 3 months of treatment and aim for > 40% reduction in non-HDL-C
If the non-HDL cholesterol is not reduced by > 40 % : Discuss adherence and timing of dose Optimize adherence to diet and lifestyle measures Consider increasing the dose (if started on less than atorvastatin 80 mg and the person is judged to be at higher risk because of comorbidities, risk score or using clinical judgment)
NICE ADVICE AND MONITORING FOR STATINS AE
.
Statins and pregnancy/lacttion
Potential teratogenicity
Stop Statins if pregnancy is a possibility
Stop Statins 3 months before any attempt to conceive and to not restart them until breastfeeding is finished
NICE ADVICE AND MONITORING FOR STATINS AE
Advise people who are being treated with a Statin:
Do not stop statins because of an increase in blood glucose level or HbA1c.
STATINS IMPACT ON RISK OF DM / DM CONTROL
Up to 9-14 % risk of new onset DM is reported from different meta-analysis esp. with high doses; Such effect of statins remains modest
Both T1D and T2D:HbA1c was slightly higher in the group treated with statins
(7.53% v.s. 7.41% . Mean difference was 0.12%, (P=0.003).
CV events were reduced by 16% in the group treated with intensive statin ;The efficacy of statins in reducing CV outcomes in T2D is well-established and of major importance to offset such HbA1c changes
Use of statins in primary prevention in T2D should not be changed.
NICE ADVICE AND MONITORING FOR STATINS AE
Statins and creatine kinase (CK)
1- Do not measure CK levels in asymptomatic people who are beingtreated with a statin
2- If patient has suggestive myopathy symptoms ( persistent generalized unexplained muscle pain, associated or not with previous lipid-lowering therapy) before or after start of a statinIf they have, measure creatine kinase (CK) levels
NICE ADVICE AND MONITORING FOR STATINS AE
Statins and creatine kinase (CK)
3- If patient has suggestive myopathy symptoms measure (CK):If CK levels are > 5 times the ULN, re-measure it after 7 days. If CK levels are still 5 times ULN, do not start statin treatment
If CK levels are raised but < 5 times ULN, start statin treatment at a lower dose
4- If statin therapy was tolerated for > 3 months ; R/O other causes of muscle pain or weakness and raised CK
NICE ADVICE AND MONITORING FOR STATINS AE
Statins and Liver Transaminases
1- Measure baseline liver transaminase enzymes (ALT or AST ) ,at baseline , 3 and 12 months of starting a statin -No more testing unless clinically indicated
2- Do not routinely exclude from statin therapy people who have liver transaminase levels that are raised but are < 3 times ULN
NICE INTOLERANCE OF STATINS
If a patient is un-able to tolerate a high-intensity statin; Treat with the maximum tolerated dose
NICE INTOLERANCE OF STATINS
Seek specialist advice (by telephone, virtual clinic or referral)
about options for treating people at high risk of CVD:
CKDType 1 diabetesType 2 diabetes
Genetic DyslipidemiaCVD, who are intolerant to 3 different statins
NICE ADVICE ON
OTHER LIPID LOWERING AGENTS /COMBINATIONS
NICE COMBINATION RX
Do not routinely offer Fibrates and Do not offer Nicotinic acid (niacin) or Bile acid sequestrants (anion
exchange resins) or omega-3 fatty acid compounds for the prevention of CVD to any of the following group of patients :
-Treated for primary prevention-Treated for secondary prevention
-With CKD-With type 1 DM-With type 2 DM
[new 2014]
NICE COMBINATION THERAPY FOR PREVENTING CVD
Ezetimibe treatment in addition to Statins should be considered
For people with primary hyper- cholesterolemia (heterozygous familial and non-familial hyper- cholesterolemia )
TAKE HOME MESSAGES
DYSLIPIDEMIA AND (CVD) TAKE HOME MESSAGES
Guidelines are GuidelinesShould not eliminate our clinical judgment
Patient centered personalized care Safest practice and
best shared-decision
DYSLIPIDEMIA AND (CVD) TAKE HOME MESSAGES
Risk assessment tools High risk groups = No need to calculate Risk
All others : Risk calculator ;Not “eyeballing” them !!
Use (non-HDL-C) (=Total-C – HDL-C) rather than LDL-C ;No need to fast
Or Fasting lipid profile : LDL-C
1.ASCVD / CHD equivalent
2-Diabetes Mellitus
3-Severe Dyslipidemia –Familial
4-CKD
5- Risk calculator : over next 10yrs
HIGH CVD RISK GROUPS - SUMMARY
NICE VS ACC/AHA VS ATP-III
NICE
low intensity 20% to 30%
medium intensity 31% to 40%
high intensity > 40%
ACC/AHA
low intensity <30%
medium intensity 30% to <50%
high intensity ≥ 50%
Targeting LDL Targeting non-HDL
ATP-III
LDL target
Reduction in LDL-C
30–40%
from base line
DYSLIPIDEMIA AND (CVD) TAKE HOME MESSAGES
Lipid-lowering drugs-Statins for primary and secondary prevention
-Use the highest tolerated dose -Combination Rx ?
Use simultaneously guidelines on other modifiable risk factors for CVD (like HTN , DM)
NICE GUIDELINES DYSLIPIDEMIA AND (CVD)
GUIDELINE DEVELOPMENT GROUP (GDG)
1-Use medium intensity statins for Primary preventionAtorvastatin 20 mg
2- Use high intensity statin for Secondary preventionAtorvastatin 80 mg
3- Do it safely Assess on regular basis for
tolerance and adverse effects
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