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2013 ACA/AHA Blood Cholesterol Guidelines
University of Southern California – Los Angeles County Hospital
Journal Club
Thursday, January 23rd, 2014
José L. González, MD
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Outline
• Methodology
• Results
• Adverse effects and monitoring
• Discussion & Controversies
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What’s New?
• No specific lipid treatment goals
• Limited scope; focus mainly on CQs
• New Pooled Cohorts Equation
• Focus on statins and statins only
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Methodology
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Organization of the Panel
• Appointed by the NHLBI
• 13 members, 3-ex members: primary care, cardiology, endocrinology, experts in clinical lipidology, clinical trials cardiovascular epidemiology and guideline development
• 16 members from NHLBI ATP IV panel
• 23 expert reviewers and representatives of federal agencies
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Methodology
• Data from RCTs and meta-analyses of RCTs (1995-2009 + RCTs published later)
• Rated fair to good quality by independent contractor
• Excluded poor quality RCTs, post-hoc analysis, observational studies
• Most studies excluded patients w/
• 2° causes of hyperlipidemia
• Triglycerides > 500
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3 Critical Questions
• What is the evidence for LDL-C and non-HDL C goals for the SECONDARY prevention of ASCVD?
• What is the evidence for LDL-C and non-HDL-C goals for the PRIMARY prevention of ASCVD?
• What is the impact on lipid levels, effectiveness, and safety of specific drugs used for lipid management in general and in selected subgroups?
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Evidence Rating
• A: strong
• B: moderate
• C: weak
• D: recommend against
• E: expert recommendation
• N: no recommendation
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Lifestyle modification
• Heart healthy diet
• Regular exercise
• Avoidance of tobacco products
• Maintenance of healthy weight
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Secondary Causes of Hyperlipidemia
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Results
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Findings
• Statins prevent both non-fatal and fatal ASCVD events
• High level of evidence for secondary prevention
• Moderate level of evidence for primary prevention
• Statins and statins only
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What was NOT found?
• Support for treatment to specific LDL and non-HDL goals
• Support for use of non-statin therapy (alone or in addition to statins)
• Support for the idea that lower cholesterol is better
• Reduced risk in patients on HD or w/ CHF
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Use of non-statin therapy
• No evidence that it provides benefit, but…
• May consider it’s use in patients on max dose therapy or w/ contraindications to statin use
• Do not lower the dose of a statin to safely add a non-statin
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4 groups that benefit
• Clinical ASCVD (includes TIA and stroke)
• LDL ≥ 190
• LDL between 70-190, but 40-75 yoa and DM
• LDL between 70-190, but 40-75 yoa and no DM
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Statin Intensity
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Pooled Cohorts Equation
• Used to estimate 10 yr risk of ASCVD
• Why not lifetime ASCVD risk?
• Lack of data on long-term f/u of RCTs 15 years
• Limited safety data for > 10 years
• Limited data on treatment of individuals < 40 yoa
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Pooled Cohort Equation
• Why a cutoff of 7.5%?
• The higher your absolute risk, the greater your benefit
• Adverse events are independent of benefit, however
• Net benefit if ASCVD risk 5-7.5% w/ mod dose statin, but discuss w/ pt
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Adverse Events
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Adverse Effects of Statins
• New onset diabetes:
• 0.1/100 for moderate intensity statins
• 0.3/100 for high intensity statins
• Myopathy: ~0.01/100
• Hemorrhagic stroke: 0.01/100
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Recommendations before starting a statin
• Check baseline ALT, but no need to monitor
• No need to check baseline CK levels
• Don’t use in females of childbearing age unless using contraceptives
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Monitoring Statin Theray
• Check initial fasting lipid panel
• Check follow-up 4-12 weeks after to determine adherence
• Perform assessments q 3-12 months as clinically indicated (?)
• Caveat: percent reduction of LDL not to be used as a treatment goal, but as an indicator of response and adherence
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Individuals w/ Predisposition to Adverse Effects:
• Multiple comorbidities, (impaired hepatic or renal function)
• Hx of previous statin intolerance or muscle disorders
• Unexplained ALT elevations 3x ULN
• Concomitant use of drugs affecting statin metabolism
• >75 yoa
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What to do in case of adverse events
• If muscle symptoms develop, stop statin, check CK, UA and Cr
• Eval for other causes
• If a causal relationship exists, switch statins
• Pregnancy category X
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Discussion& Controversies
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Why not use specific goals?
• RCTs use fixed dose statins
• Data = ASCVD events reduced by using max-tolerated intensity
• LDL goals may result in under-tx, or over-tx w/ non-statin
• AIM-HIGH – futility of adding niacin to pts w/ high triglycerides
• ACCORD subgroup: fenofibrates in DM, needs further study + compare to statins
• Familial hyperlipidemia may be unable to achieve goal, not necessarily tx failures
• Type 2 DM = often have lower LDLs at baseline, under-tx
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What about non-statins?
• Data do not show improved outcomes.
• Recommendations do include safety precautions when used.
• May be of use when patients cannot tolerate an indicated statin.
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What about patients on HD or with CHF?
• No recommendation. Not even an E.
• 4 RCTs reviewed in these subgroups: no reduction in 2
• Insufficient evidence on which to base recommendations for or against
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Individuals Already on a Statin
• if baseline LDL is unknown, an LDL < 100 was observed in most individuals receiving high intensity statin (i.e. put them on high dose)
• RCT does support continuation of statins beyond 75-yoa in those already tolerating them
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What about other tests and biomarkers?
• CAC score
• Non-HDL-C
• Apo-B
• LP(a) or LDL particles
• Non-invasive testing
• Lifetime ASCVD risk
• ASCVD risk 5-7.5%
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Strengths & Limitations
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Strengths
• Most of the controversies arise from lack of data
• Strength of recs: doesn’t include specious recommendations, few grade E
• Limited to very high level of evidence
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Limitations
• Patients <40 yoa have a low estimated 10-yr ASCVD risk score, thus don’t qualify for treatment, yet they may have a high lifetime risk score
• No data on special subpopulations who are likely at high risk of ASCVD (individuals w/ HIV, rheumatologic or inflammatory dz, s/p x-plant)
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Future Directions
• Adults > 75 yoa
• Titration of meds to specific LDL goals
• Combination of submaximal statins w/ non-statins
• Management of hypertigylceridemias
• Use of other markers (apo-B, non-HDL, LP(a) or LDL particles,
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Sources
• Keaney JF, Curfman GD, Jarcho J. “A Pragmatic View of the New Cholesterol Treatment Guidelines.” N Engl J Med 2014; 370:275-278. January 16, 2014.
• Stone NJ, Robinson J, Lichtenstein AH et al “2013 ACC/AHA Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines.” J Am coll Cardiol. 2013; 90:’ doi:10.1016/j,jacc.2013.11.002.