Ten Things Every Clinician Should Know About the 2013 ACC/AHA Lipid Guidelines

“The pessimist complains about the wind; the optimist expects it to change; the realist adjusts the sails.”  – William Arthur Ward.
 

After a decade of waiting, new treatment guidelines on the management of cholesterol in adults were published on November 12, 2013.^1,2,3 These guidelines depart quite significantly from previous recommendations and have already generated some controversy. Here are the top ten things every clinician should know and do.
 

1. Evidence, evidence, evidence! The authors took a hard line approach regarding what evidence to review and only evaluated randomized controlled trials (RCT’s) to determine which patients would benefit from treatment.¹ Notably, non-statin therapies – used alone or in combination with statins – are not generally recommended because they lack sufficient evidence to support their routine use.
 

2. Forget Those Fixed LDL Goals!  Despite decades of treating individuals to a low-density lipoprotein cholesterol (LDL-C) goal, the new guidelines favor a percentage change in LDL-C from baseline.¹ The rationale for this change is based on the fact that no RCT has treated individuals to a specific LDL-C target.  In clinical trials patients receiving a fixed-dose statin capable of lowering LDL-C by at least 30% from baseline had a significant reduction in cardiovascular events.   The guideline authors do point out that most patients in the RCT’s achieved an LDL-C <100 mg/dL. Therefore, an LDL-C <100 mg/dL may be a reasonable target for those patients already taking statins, particularly if their baseline LDL-C is not known.
 

3. Identify Patients at Risk. The authors identified four groups where the benefit of statin therapy clearly outweighs the potential risks.^1,2  These include people with: 1) clinically evident atherosclerotic cardiovascular disease (ASCVD); 2) a LDL-C > 190 mg/dL; 3) diabetes who are 40-75 years of age; and, 4) a 10-year risk > 7.5% who are 40-75 years of age. The aim of this approach was to simplify the decision regarding which patients to initiate treatment based on evidence from RCT’s.
 

4. Use the New (and Improved?) Risk Calculator. The new Pooled Cohort Risk Assessment has replaced the Framingham Risk Calculator.²  This calculator includes ethnicity and gender. In addition to coronary heart disease, fatal and nonfatal stroke are included in the calculator outcome. Despite these improvements, the new risk calculator has not been vetted and omits some important patient populations (e.g., Hispanic and Asian Americans). Compared to observed event rates in primary prevention patients, the new risk calculator may overestimate risk by as much as 75%-150%. Future guideline revisions will likely increase the precision of the calculator to more accurately guide treatment decisions.
 

5. Focus on Statin “Intensity” and Dose. The new treatment paradigm recommends fixed-dose statins based on patient risk.¹  Patients at moderate ASCVD risk should receive a moderate-intensity statin capable of lowering LDL-C by 30-50%.  Patients with established ASCVD or diabetes and a 10-year risk >7.5% should receive a high-intensity statin capable of lowering LDL-C by > 50%. Although many statins are capable of achieving a 30-50% reduction in LDL-C, only atorvastatin 80mg and rosuvastatin 20mg daily can consistently deliver a > 50% reduction in LDL-C. Tolerability can be a problem for some patients who try to take high-dose statins, so combination lipid therapy can be considered in order to achieve the desired > 50% reduction.
 

6. Non-traditional risk factors aren’t ready for prime time. Family history, high sensitivity-C reactive protein (hs-CRP), coronary artery calcium score, and ankle brachial index are only recommended in patients whose risk is uncertain after using the Pooled Cohort Risk Assessment.²  Furthermore, no recommendations were made regarding apolipoprotein B, chronic kidney diseases, albuminuria, and cardiorespiratory fitness.  Routine carotid intimal media thickness was not recommended for routine use. The biggest surprise was the omission of hs-CRP, which has been strongly advocated by some experts as a valid marker of cardiovascular risk and used in the Reynolds Risk Score.
 

7. Non-statin therapies take a back seat.  The authors conclude that non-statin therapies offer no benefit and should only be considered in patients who: 1) do not respond as expected to statins; 2) are unable to tolerate the recommended statin dose intensity; or, 3) experience statin intolerance.¹  Findings from AIM-HIGH, HPS2, and ACCORD-LIPID suggest that adding non-statin therapies to patients already at their LDL-C goal offers no benefit beyond the statin effect; however, these trials did not evaluate the benefit of combination therapies in statin-treated patients with persistently elevated LDL-C levels.  Older RCT’s indicate that combination therapy, especially statins with niacin, improves mortality in patients with high cardiometabolic risk.
 

8. Use Lab Data To Evaluate and Monitor Patients.  A lipid profile, liver function tests, A1C, and thyroid function tests should be obtained at baseline to evaluate secondary causes of dyslipidemia.¹  Follow-up lipid profiles should be obtained at 4-12 weeks after starting a statin then every 3-12 months thereafter to assess response and adherence.  Patients with an LDL-C < 40 mg/dL on two consecutive occasions should have their statin dose reduced.
 

9. Increase Your Emphasis on Lifestyle Modification. The benefits of lifestyle modification are well established. In the new guidelines, providers are encouraged to stress lifestyle modification more vigorously for those patients who do not achieve the expected percentage reduction in LDL-C before adding a non-statin to the regimen.³  Specific lifestyle recommendations can be found in a separate companion guideline.
 

10. Many Questions Remain. The guidelines identify five major evidence gaps: 1) evidence to support the use of statins for primary CVD prevention in adults >75 years of age; 2) the comparative efficacy of titrating to specific treatment goals versus fixed-dose statin therapy; 3) the benefits of various lipid therapy combinations on CVD risk reduction (not changes in lipid parameter); 4) the risk of new-onset diabetes associated with each statin; and 5) the “hard” outcomes of new, emerging lipid therapies on ASCVD event rates.  It is expected the guidelines will be periodically updated as these questions are addressed in RCT’s.  Let’s hope it won’t take another 10 years!
 

The 2013 ACC/AHA Cholesterol Management Guidelines will significantly alter the way we manage dyslipidemia.^1,2  Despite the criticism already mounted against these guidelines⁴, their implementation is inevitable.  Without population-wide LDL-C treatment goals, how will we assess quality of care and the effectiveness of lipid clinics? Will this simplified approach lead to wider utilization of statins and improve outcomes? What do you think the impact of the new guidelines will be?