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2013 ACC/AHA Guideline - Cholesterol Treatment Protocols 1, 2

Pooled Cohort Equations (calculator) Cholesterol Treatment Decision Tool - LATEST guidelines Cholesterol treatment regimens - LATEST guidelines (Select)led

Select Indication for statin therapy

Background Info

In many cases direct quotes are used from the primary reference: 
Stone NJ, Robinson J, Lichtenstein AH, Bairey Merz CN, Lloyd-Jones DM, Blum CB, McBride P, Eckel RH, Schwartz JS, Goldberg AC, Shero ST, Gordon D, Smith SC Jr, Levy D, Watson K, Wilson PW. 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 Nov 7. pii: S0735-1097(13)06028-2. doi: 10.1016/j.jacc.2013.11.002.


Four 'Statin Benefit Groups' have been identified that have the potential to reduce the risk of atherosclerotic cardiovascular disease.  The benefit of therapy has been found to clearly exceed the potential for adverse effects in adults.   The four groups are as follows:

  1. Individuals with clinical ASCVD (Secondary prevention):   Clinical ASCVD Atherosclerotic Cardiovascular Disease is defined by the inclusion criteria for the secondary prevention statin RCTs (acute coronary syndromes, or a history of MI, stable or unstable angina, coronary or other arterial revascularization, stroke, TIA, or peripheral arterial disease presumed to be of atherosclerotic origin). 

  2. Individuals with primary elevations of LDL-C geq190 mg/dL.

  3. Individuals 40 to 75 years of age with diabetes and LDL-C 70-189 mg/dL. For the primary prevention of ASCVD in individuals with diabetes (diabetes mellitus type-1 and type-2), estimated 10-year ASCVD risk can also be used to guide the intensity of statin therapy.

  4. Individuals without clinical ASCVD or diabetes who are 40 to 75 years of age with LDL-C 70- 189 mg/dL and an estimated 10-year ASCVD risk of 7.5% or higher.   Data has shown that statins used for primary prevention have substantial ASCVD risk reduction benefits across the range of LDL-C levels of 70-189 mg/dL.


Flowchart:1
Initial steps: Counseling on a heart healthy lifestyle forms the foundation of ASCVD prevention.  Pooled Cohort equations:   Individuals not receiving cholesterol-lowering drug therapy, should have their estimated 10-year ASCVD risk calculated initially, and then every 4 to 6 years in individuals aged 40 to 75 years without clinical Atherosclerotic Cardiovascular Disease or diabetes and with LDL-C 70-189 mg/dL.

Decision point:
1] Adults age >21 years old and a candidate for statin therapy [if Yes] AND Diagnosis: Clinical
       ASCVD  [if YES] --> 2 paths:
    (a) Age leq75 years  - [if YES]  Start High-intensity statin (Use Moderate-intensity statin if not a candidate for high-intensity
       statin).

Background:  (direct quotes)  1
Moderate-intensity statin therapy should be used in individuals in whom high-intensity statin therapy would otherwise be recommended when characteristics predisposing them to statin associated adverse effects are present. Characteristics predisposing individuals to statin adverse effects include, but are not limited to: 

  • Multiple or serious comorbidities, including impaired renal or hepatic function.  
  • History of previous statin intolerance or muscle disorders.  
  • Unexplained ALT elevations >3 times ULN. 
  • Patient characteristics or concomitant use of drugs affecting statin metabolism. 
  • >75 years of age.


     (b) Age >75y or if not candidate for high-intensity statin-->[if YES]  start moderate-intensity statin.

Decision point:
2] LDL-C geq 190?  -->[if YES]  -->  Start high-intensity statin  (Moderate-intensity statin if not a candidate for high-intensity statin).

Decision point:
3] Diabetes type 1 or 2 AND age 40-75y AND LDL-C 70-189 mg/dL.?  [ if YES] --> Start Moderate-intensity statin  [support for high-intensity: "Giving a maximally tolerated statin intensity should receive primary emphasis because it most accurately reflects the data that statins reduce the relative risk of ASCVD events similarly in individuals with and without diabetes, and in primary and secondary prevention in those with diabetes, along with evidence that high-intensity statins reduce ASCVD events more than moderate-intensity statins."]

Decision point:
4] No to all above?  -->[if YES] Estimate the 10-year ASCVD risk with the Pooled Cohort Equations --> 
Is the estimated 10-y risk geq7.5  AND age 40-75 [if YES] --> Start Moderate to high intensity statin.  

 IF NO e.g. estimated 10-y risk <7.5   -->  ASCVD prevention benefit of statin therapy may be less clear in other groups.  In selected individuals, consider the following:

  • Review additional factors influencing ASCVD risk
  • Review potential ASCVD treatment risks, benefits and adverse effects
  • Review potential drug-drug interactions
  • Determine patient preferences for statin treatment.


Statin therapy:  monitoring therapeutic response and adherence:



Flowchart:
  • Assess medication and lifestyle adherence - fasting lipid panel etc.  Was the anticipated response achieved ?   [E.g.  high-intensity statin regimen:   geq 50 percent reduction in LDL-C from untreated baseline or moderate-intensity statin therapy- LDL-C reduction of ~30 - <50% from untreated baseline]
    • [if YES] --> - reinforce continued adherence --> follow-up in 3 to 12 months.
    • [if NO]  --> (Less than anticipated result) --> [Was there intolerance to the recommended statin dose - [YES / NO] -->
      • [if YES] - Review the section on management of statin intolerance (Stone NJ et al.  2013 ACC/AHA Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults: ....)
      • [if NO] -  reinforce medication adherence and adherence to intensive lifestyle changes. Also exclude secondary causes of hypercholesterolemia.   Follow-up in 4 to 12 weeks.


References

  1. Stone NJ, Robinson J, Lichtenstein AH, Bairey Merz CN, Lloyd-Jones DM, Blum CB, McBride P, Eckel RH, Schwartz JS, Goldberg AC, Shero ST, Gordon D, Smith SC Jr, Levy D, Watson K, Wilson PW. 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 Nov 7. pii: S0735-1097(13)06028-2. doi: 10.1016/j.jacc.2013.11.002.
  2. Goff DC Jr, Lloyd-Jones DM, Bennett G, O'Donnell CJ, Coady S, Robinson J, D'Agostino RB Sr, Schwartz JS, Gibbons R, Shero ST, Greenland P, Smith SC Jr, Lackland DT, Sorlie P, Levy D, Stone NJ, Wilson PW. 2013 ACC/AHA Guideline on the Assessment of Cardiovascular Risk: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2013 Nov 12. pii: S0735-1097(13)06031-2. doi: 10.1016/j.jacc.2013.11.005.
  3. Lloyd-Jones DM, Leip EP, Larson MG, D'Agostino RB, Beiser A, Wilson PW, Wolf PA, Levy D. Prediction of lifetime risk for  cardiovascular disease by risk factor burden at 50 years of age. Circulation. 2006 Feb 14;113(6):791-8. Epub 2006 Feb 6.
ACC/AHA Guideline -Cholesterol Treatment Protocols