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2013 ACC/AHA guidelines for blood cholesterol management


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2013 ACC/AHA guidelines for blood cholesterol management

  1. 1. 2013 ACC/AHA Blood Cholesterol Treatment Guidelines “Intensity Of Statin Therapy” Aim to Reduce RISK … not at Target levels
  3. 3. Scope of guideline • to reduce atherosclerotic cardiovascular disease(ASCVD)risk {RCTs,systematic analysis and metaanalysis of RCTs}. • ASCVD – coronary heart disease(CHD),stroke,and peripheral arterial disease,all of presumed atherosclerotic origin. • to provide strong evidence-based foundation. • only evidence from statin RCTs were used to develop guidelines.**** • Comprehensive approach to lipid management for purposes with relation to ASCVD reduction only,not for complex lipid disorders.
  4. 4. What do present guidelines say.....
  5. 5. Patient centered approach rather than one treatment fits all
  6. 6. What’s new in the guideline…?
  7. 7. Benefits of Statins • High intensity therapy – lowering LDL cholesterol by >50%. • Moderate intensity therapy - lowering LDL cholesterol by 30-50%. • Reduces ASCVD events across the spectrum of baseline LDL-C levels > 70 mg/dl. • Relative reduction in ASCVD risk is consistent for primary and secondary prevention.  Absolute reduction in ASCVD events is proportional to baseline absolute ASCVD risk.  Statin therapy only for individuals at increased ASCVD risk .
  8. 8. Who are to be benefited by Statins ?????
  9. 9. Primary prevention of ASCVD • Based on the estimated absolute 10 yr risk of ASCVD (non fatal MI,CHD death,nonfatal and fatal stroke)… • The omnibus CV risk calculator for  Pts without clinical ASCVD and LDL 70-189mg/dl Estimates 10 yr risk of ASCVD  In diabetics ,for primary prevention Not in pts with clinical ASCVD
  10. 10. Statin treatment:Recommendations
  11. 11. Primary prevention in patients with LDL>190mg/dl LDL-C >190mg/dl Age>21 years Evaluate for cause Management primary secondary High dose statin Maximum tolerated dose LDL-C reduction of atleast 50% IB IB IIaB Evaluate and treat accordingly
  12. 12. Primary prevention in patients with diabetes LDLcholesterol 70-189 mg/dl Diabetes Age Statins 40-75 yrs <40 yrs, >75yrs Moderate intensity statins High intensity statins with risk >7.5% Balance between ASCVDbenefits and adverse effects IA IIa B IIa C
  13. 13. Patients without diabetes,primary prevention LDLcholesterol 70-189 mg/dl >7.5 % 10 yr ASCVD risk estimate Age of the patient 40-75 yrs Moderate to high intensity therapy IA 5-7.5% >75 yrs Assess risk, benefits 40-75 yrs Moderate intensity therapy IIa B >75 yrs Assess risks benefits
  14. 14. Statins in Heart Failure, Hemodialysis patients
  15. 15. LDL cholesterol >190 mg/dl Pt had CAD, HTN,smoker, not on statins Age 45 yrs Age 75 yrs Start Statins to the maximum tolerated dose Pt diabetic,no CAD, ASCVDrisk >7.5% Assess risk,benefits High intensity statins 70-189 mg/dl Pt not diabetic, noCAD Pt CAD Evaluate secondary causes Statins High dose statin therapy Pt diabetic Moderat dose statins Pt no h/o CAD, DM2, risk <7.5% Assess risk, benefits Pt having CKD No EBT for statins
  16. 16. High- Moderate – and Low – Intensity Statin Therapy Clinical application by Statin dose
  17. 17. STATINS HIGH INTENSITY THERAPY MODERATE INTENSITY THERAPY Daily dose lowers LDL-C on average,by approximately ≥50% Daily dose lowers LDL –C Daily dose lowers LDL –C on average,by <30% approximately 30-50% Atorvastatin (40) 80 mg Atorvastatin 10 (20) mg Simvastatin 10 mg Rosuvastatin 20 (40) mg Rosuvastatin (5) 10 mg Pravastatin 10-20 mg Simvastatin 20-40 mg Lovastatin 20 mg Pravastatin 40 (80) mg Fluvastatin 20-40 mg Lovastatin 40 mg Pitavastatin 1 mg Fluvastatin XL 80 mg Fluvastatin 40 mg bid Pitavastatin 2-4 mg LOW INTENSITY THERAPY
  18. 18. Safety recommendations of statins NHLBI ACC/AHA COR 1.Creatine Kinase,routinely not needed A III no benefiit 2.Baseline CK in pts at risk of events E 3.Baseline ALT before initiating statins LOE A B IIa I C B 4.Decreasing the statin dose,if 2 consecutive values of LDL-C <40 mg/dl. C IIb C 5.Simvastatin at 80 mg daily harmful B 6.New onset diabetes on statin therapy,continue statins B III harm I A B 7.If muscle symtpoms develop,discontinue,use again E II a C 8.Confusional state,see secondary causes E II b C
  19. 19. Monitoring statin treatment What do guidelines say..
  20. 20. Lifestyle is the foundation for ASCVD risk reduction  Adhering to a healthy heart diet,  Regular exercise habits  Avoidance of tobacco products  Maintenance of healthy weight • Remains critical component both prior to and in concert with the use of cholesterol lowering drug therapies
  21. 21. What is the fate of nonstatins in guidelines are they Ignored??
  22. 22. Niacin Niacin Baseline hepatic transaminases,FBS,HBA1c Start at low dose Hepatic transaminases elevations are higher >2-3ULN Take niacin with food or aspirin Persistent severe cutaneous symptoms,hyperglycemia, acute gout 500 mg ER to 2000mgER New onset AF, weight loss
  23. 23. Bile acid sequestrants Baseline TG >300 mg/dl 250-299 mg/dl Cholesterol absorption inhibitors Baseline hepatic transaminases Discontinue if ALT>3 times occur Fibrates IA IIa/IIbB III Omega 3 fatty acids Gemfibrozil in patients on statin therapy Severe hypertriglyceridemia If TG>500mg/dl and benefit>risks Evaluate GI disturbances GFR<30 ml/min
  24. 24. Secondary causes of hyperlipidemia Secondary cause Elevated LDL - C ELEVATED TRIGLYCERIDES DIET Saturated or trans fats, wt gain,anorexia Wt gain, very low fat diets, high intake of refined carbohydrates, excessive alcohol intake DISEASES Biliary obstruction , nephrotic syndrome Nephrotic syndrome, CKD, lipodystrophies DRUGS Duiretics,cyclosporine, glucocorticoids,amiodarone Oral estrogens,glucocorticoids, bile acid sequestrants protease inhibitors, retinoic acid,sirolimus, beta blockers,thiazides ALTERED METABOLISM Hypothyroidism, Obesity,pregnancy Diabetes, hypothyroidism, obesity, pregnancy Statins,niacin,ezetimbe C/I in pregnancy,lactation
  25. 25. Evolution of guidelines NCEP ATP I 1988 NCEP ATPIII 2001 NCEP ATP II 1993 NCEP ATP IV 2013?? NCEP ATP III REVISED 2004 ACC/AHA 2013
  26. 26. Basis for the New Guidelines
  27. 27.  RCTs reviewed showed a consistent reduction in ASCVD events from Statins therapy in secondary and primary prevention, no ASCVD event reduction in those with NYHA class II-IV HF or receiving maintenance hemodialysis.  Only fixed doses of statins with placebo or untreated controls,comparison of high dose with moderate intensity statins.  No evaluation of the effect of titrated (dose adjusted) statin treatment to achieve prespecified LDL- C or non HDL-C goals.  Use of niacin to additionally lower non HDL –C,once an LDL target was achieved,did not further reduce ASCVD outcomes.(AIM HIGH trial)  The intensity of statin therapy is appropriate on those most likely to benefit.
  28. 28. 3 CQs – CQ1 secondary,(19RCT) CQ2 – primary prevention (6RCT) CQ3 – comprehensive management,safety of each drug • • • Rosuvastatin to prevent vascular events in men and women with elevated C-reactive protein. N Engl J Med 2008;359:2195-207 AFCAPS-TEXCAPS, JAMA 1998;279:1615–1622 MEGA trial, Lancet 2006;368:1155–1163.
  29. 29. Why other approaches ignored???
  30. 30.  1.Treat to Target – widely used for past 15 yrs What is the target ? What is the additional risk reduction beyond one target lower than other? adverse effects from multidrug therapy that occur in achieving goal undertreatment with statins, overtreatment with nonstatins  2.lowest is best adverse effects?  3.lifetime risk long term follow up >15 yrs? statins>10yrs?
  31. 31. Why Target level therapy came the picture of statin benefit groups? Hypothesis or Evidence based.. Myth or reality
  32. 32. A.Secondary Prevention  Evidence – high intenisty therapy to maximally lower LDL –C than using a target.  Ex – LDL –C 78mg/dl on a dose of atorvas 80 mg/dl –receiving EBT.  No data to show that adding a nonstatin drug to high intenisty statin therapy will provide incremental ASCVD risk reduction benefit with acceptable margin of safety.(AIM HIGH,ACCORD).  This patient may be exposed to adverse effects if started of a drug with no evidence of benefit,just because his LDLis more than arbitrarily level.  This is treated as a case of failure..for a lag of 8 mg/dl..Is it justifiable ??? AIM HIGH trial NewEngl J Med 2011;365:2255-67 ACCORD, N Engl J Med 2010;362:1563–74 .
  33. 33. B.FH with LDL –C >190 mg/dl  many does not achieve <100mg/dl.  maximum may be 120 mg/dl on 3 drugs.  These pts may have fallen short of target ,but their LDL –C >50% ,more ASCVD risk reduction.  Not treatment failures. C.Type2Diabetes :  have lower LDL-C than with without diabetes.  goal directed therapy encourages low statin doses,use of drugs for addressing HDL-C/high TG.  maximally tolerated therapy to be given primary importance. D.Estimated ASCVD >7.5% Cholesterol Treatment Trialists Collaboration, Lancet 2012;380:581–90. Taylor F, Ward K, Moore TH et al. 2011:CD004816
  34. 34. Limitations • Clinical judgement required in pts,for whom RCT evidence is insufficient • Younger adults< 40 yrs with <7.5% ASCVD risk for 10 yrs,high lifetime risk. • HIV pts,rheumatological pts,IBD pts. • RCTS,Systematic reviews,meta analysis of RCTs were taken into consideration.
  35. 35. New Drugs • Cholesterol ester transfer protein (CETP) inhibitors - Anacetrapib(DEFINE,REVEAL), dalcetrapib • Ab to pro-protein convertase subtilisin/kexin 9 (PCSK9). • Apolipoprotein B synthesis inhibitors - Mipomersen • Microsomal triglyceride transfer protein (MTP) inhibitors, • Thyroid hormone analogue Eprotirome
  36. 36. Future..  Primary prevention in >75 yrs age  Alternate treatment strategies.  Effectiveness of submaximal doses of statins vs nonstatins in intolerant pts  Evaluation of the incidence of new onset diabetes associated with statin therapy.  Outcomes of RCTs of new lipid modifying agents to determine the incremental ASCVD reduction when added to statin therapy.
  37. 37. Future updates required for..  1.The treatment of Hypertriglyceridemia.  2.Use of NonHDL-C in decision making.  3.Whether on-treatment markers such as apoB,Lp(a),LDLparticles are useful in guiding decisions.  4.Best approaches to use noninvasive imaging for refining risk estimates to guide treatment.  5.Optimal age for starting treatment for reducing lifetime risk of ASCVD.  6.What to do in pts with HF,hemodialysis.  7.Long term effects of statin associated new onset diabetes and management.
  38. 38. Conclusions  Patient centered approach is to be given importance rather than one treatment fits all concept.  Statins to be given at high intenisty,moderate intensity doses but not with target levels of attainment.  Nonstatins give no ASCVD benefit in pts with high intensity statin therapy.  Use of lipoprotein a ,non HDLcholesterol levels assessment is not recommended.  Pts without ASCVD should be started of the statins after assessing 10 yr risk by omnibus calculators.  New onset diabetes due to statins needs further assessment in future.  New drugs in pipeline,RCT s required for their incremental benefit in ASCVD risk reduction when added to statins  Lifestyle modification remains the key concept of the management of blood cholesterol.