2013 ACC/AHA Cholesterol Guidelines JULIE HAMMOND, D.O. PGY-2 MATTHEW PAOLI, D.O. PGY-2

Transcription

1 2013 ACC/AHA Cholesterol Guidelines JULIE HAMMOND, D.O. PGY-2 MATTHEW PAOLI, D.O. PGY-2

2 GOALS ACC/AHA as publisher of guidelines Determining which patients are appropriate for statin therapy The treatment guidelines Monitoring outcomes of therapy

3 UPDATE ON GUIDELINES Initiated by the National Heart, Lung, and Blood Institute (NHLBI) Coordinated hand off for ACC, AHA, and collaborating societies to complete guidelines and continue future recommendations Recommendations derived from randomized trials, meta-analyses, and observational studies to reduce risk of ASCVD events.

4

5 4 MAJOR STATIN BENEFIT GROUPS 1. Secondary Prevention: Individuals with clinical ASCVD 2. Primary prevention: Individuals without clinical ASCVD and A. Primary LDL-C level 190 mg/dl B. Persons with diabetes aged 40 75yr with an LDL-C level of mg/dl C. Persons aged 40 75yr without diabetes with an LDL-C level of mg/dl AND an estimated 10-year ASCVD risk 7.5%

6

7 PRIMARY LDL-C LEVEL 190 MG/DL Each 39mg/dL reduction in LDL-C by statin therapy reduces ASCVD risk by 20% Primary, severe elevations of LDL-C Require more substantial reductions and intensive risk factor management Reasonable to use a high-intensity statin to achieve at least 50% reduction in LDL. Consider use of non-statin cholesterol lowering medications if inadequate lowering of LDL-C with statin alone Family screening is especially important in this group Secondary, severe elevations of LDL-C Consider EtOH-ism, uncontrolled DM, and overt albuminuria

8 DM 40-75YRS WITH LDL-C MG/DL High level of evidence for moderate-intensity statin therapy No studies evaluated high-intensity statin therapy in primary prevention in a population with DM Recommendation for use of 10yr ASCVD risk calculator to guide level of statin intensity is based on strong evidence supporting high-intensity statin therapy with 10yr ASCVD risk 7.5% in persons without DM

9 LDL-C mg/dl & 10y ASCVD Risk 7.5% Initiation of statin therapy should be based on 10yr ASCVD risk calculator regardless of sex, race, or ethnicity

10 POOLED COHORT EQUATIONS my.americanheart.org/cvriskcalculator

11 COMPONENTS OF RISK CALCULATOR Gender Age Race (White, Black, other) Total Cholesterol (mg/dl) HDL (mg/dl) Systolic Blood Pressure Treatment for Hypertension Diabetes Smoker

12 LDL-C AND NON HDL-C GOALS No recommendations are made for or against specific LDL-C or non-hdl-c goals for primary or secondary prevention of ASCVD RCT evidence shows that ASCVD events are reduced by using the maximum tolerated statin intensity in groups shown to benefit No RCT s that showed improved outcomes when drug therapy was titrated to specific LDL-C and non-hdl-c goals LDL-C targets may result in under-treatment with statin therapy or over-treatment with non-statin drugs not proven to effectively reduce ASCVD risk

13 SPECIAL POPULATIONS Clinical ASCVD, >75y evaluate potential for ASCVD risk reduction benefits, adverse effects, drug-drug interactions 21y, ASCVD risk 7.5% or 40-75y, ASCVD risk < 5% Consider additional factors to inform tx decision making 1 o LDL-C 160mg/dL or other evidence of genetic HLD, FHx of premature ASCVD, sensitivity CRP 2mg/dL NYHA class II-IV heart failure or maintenance HD Insufficient information from RCT on which to base recommendations for or against treatment consider risks vs. benefits

14 INTENSITY OF STATIN THERAPY Classified on basis of average expected LDL-C response to a specific statin and dose High Intensity Statins: LDL-C 50% Moderate Intensity Statins: LDL-C ~30-50% Low Intensity Statins: LDL-C <30% Classification by dose and percent reduction is based on evidence that the relative reduction in ASCVD risk from statin therapy is related to the degree which LDL-C is lowered.

15 High Intensity Statin Therapy Atorvastatin (40*)-80mg Rosuvastatin 20 (40)mg - Clinical ASCVD and Age <75y - LDL-C 190mg/dL - DM, Age 40-75y and 10y ASCVD risk 7.5% Moderate Intensity Statin Therapy Atorvastatin 10 (20)mg Rosuvastatin (5) 10mg Simvastatin 20-40mg Pravastatin 40 (80)mg Lovastatin 40mg Fluvastatin XL 80mg Fluvastatin 40mg BID Pitavastatin 2-4mg - Clinical ASCVD and age >75y OR not candidate for high intensity statin - DM and age 40-75y - 10y ASCVD risk 7.5% and age 40-75y(moderate to high) Low Intensity Statin Therapy Simvastatin 10mg Pravastatin 10-20mg Lovastatin 20mg Fluvastatin 20-40mg Pitavastatin 1mg -Used when high or moderate intensity statins are not tolerated

16 PRIOR TO STATIN INITIATION Initial Evaluation FLP ALT HA1C (if DM status unknown) CK (if indicated) Consider evaluation for other secondary causes or conditions that may influence statin safety Evaluate & Treat Lab Abnormalities TG 500mg/dL 500 AHA recommends drug therapy in addition to TLC Fibrates>IR niacin>omega3 fatty acid>er niacin>statin>ezetimibe LDL-C 190mg/dL Secondary Causes If primary, screen family for FH Unexplained ALT >3x ULN

17 Secondary Cause Elevated LDL-C Elevated TG Diet Saturated or trans fats, wt gain, anorexia Wt gain, very low-fat diets, high intake of refined carbohydrates, excessive EtOH intake Drugs Diuretics, cyclosporine, glucocorticoids, amiodarone Oral estrogens, glucocorticoids, bile acid sequestrants, protease inhibitors, retinoic acid, anabolic steroids, sirolimus, raloxifene, tamoxifen, beta-blockers (NOT carvedilol), thiazides Diseases Disorders and altered states of metabolism Biliary obstruction, nephrotic syndrome Hypothyroidism, obesity, pregnancy* Nephrotic syndrome, chronic renal failure, lipodystrophies Diabetes (poorly controlled), hypothyroidism, obesity; pregnancy* *Cholesterol and triglycerides rise progressively throughout pregnancy; treatment with statins, niacin and ezetimibe are contraindicated during pregnancy and lactation.

18 STATIN SAFETY Characteristics predisposing individuals to statin adverse events include: Multiple or serious comorbidities including impaired hepatic or renal function Hx of previous statin intolerance or muscle disorder Unexplained ALT > 3x ULN Pt characteristics or concomitant use of drugs affecting statin metabolism > 75 years of age Hx of hemorrhagic stroke Asian ancestry

19 (LOE B) Clinical ASCVD: - h/o MI - stable or unstable angina - Coronary revascularization - Stroke - TIA w/ presumed atherosclerotic origin - PAD or revascularization

20

21 4-12wks after initiation (LOE A)

22 STATIN INTOLERANCE Evaluate and tx muscle sx including pain, tenderness, stiffness, cramping, weakness or fatigue in statin treated patients according to following recommendations (LOE B) Obtain hx of prior or current muscle sx to establish baseline prior to Rx initiation If unexplained severe muscle sx or fatigue develop during tx, d/c statin and evaluate for possible rhabdomyolysis CK, creatinine and U/A for myoglobinuria Mild to moderate muscle sx, d/c statin until sx can be evaluated Evaluate for other conditions a/w muscle sx Hypothyroid, altered renal/hepatic fxn, PMR, steroid myopathy, vit D def, primary muscle diseases May restart after resolution of sx at original or lower dose If causal relationship > d/c and use low dose of different statin

23 ADDITIONAL MONITORING No recommendation to monitor ALT levels Measure hepatic function if sx suggesting hepatotoxicity Unusual fatigue or weakness, loss of appetite, abdominal pain, dark colored urine, jaundice CK should NOT be routinely measured Measure CK in individuals with muscle sx pain, tenderness, stiffness, cramping, weakness, generalized fatigue Evaluate for new-onset DM according to current screening guidelines

24 REFERENCES Miller M, Stone NJ, Ballantyne C et al. Triglycerides and cardiovascular disease: a scientific statement from the American Heart Association. Circulation 2011; 123: Stone, Neil J., MD, and Jennifer Robinson, MD. "2013 ACC/AHA Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults: A Report of the American Colleg of Cardiology/American Heart Association Task Force on Practice Guidelines." Circulation (2013): n. pag. Web. 20 Mar < a.citation>. Stone, Neil J., MD, and Jennifer G. Robinson, MD, MPH. "Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Disease Risk in Adults: Synopsis of the 2013 American College of Cardiology/American Heart Association Cholesterol Guidline." Annals of InternalMedicine (2014): Web.