Disclosures No relationships (not even to an employer) No off-label uses. Cholesterol Lowering Guidelines: What now?

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1 Disclosures No relationships (not even to an employer) No off-label uses Cholesterol Lowering Guidelines: What now?, FACP year-old white woman Total cholesterol 175mg/dL HDL 54 mg/dl LDL 96 mg/dl BP 134 mmhg while taking lisinopril, 5 mg/d 47-year-old African American man Total cholesterol 170 mg/dl HDL 45 mg/dl LDL 95mg/dL BP 129 mmhg while taking HCTZ 25 mg/d 3 4 1

2 Statins save lives Learning Points Review latest treatment guidelines for lowering elevated cholesterol o Risk, not LDL, is now the threshold for treatment Discuss how to implement them in your practice Lancet 2010, PMID: For whom is treatment recommended? Clinical ASCVD (Atherosclerotic Cardiovascular Disease), regardless of age Acute Coronary Syndrome Myocardial Infarction Stable or Unstable Angina Revascularization Procedures (coronary or otherwise) Stroke or Transient Ischemic Attack Atherosclerotic Peripheral Arterial Disease LDL 190 mg/dl, regardless of age Type 1 or 2 Diabetes AND age years 10-year ASCVD Risk 7.5% AND age years High Intensity Moderate Intensity Low Intensity Atorvastatin (40 ) 80 mg Atorvastatin 10 (20) mg Simvastatin 10 mg Rosuvastatin 20 (40) mg Rosuvastatin (5) 10 mg Pravastatin mg Simvastatin mg Lovastatin 20 mg Pravastatin 40 (80) mg Fluvastatin mg Lovastatin 40 mg Pitavastatin 1 mg Fluvastatin XL 80 mg Fluvastatin 40 mg BID Pitavastatin 2 4 mg Bold: Doses evaluated in RCTs and included in Lancet 2010, PMID: ; all demonstrated a reduction in major cardiovascular events Italic: Doses approved by the FDA but which were not tested in the RCTs reviewed 7 8 2

3 ASCVD 75 years Age? High intensity statin > 75 years Moderate intensity statin Age? DM years without ASCVD and with LDL mg/dl Moderate intensity statin 7.5% 10 year ASCVD risk? High intensity statin 9 10 Age? years without DM or ASCVD with 7.5% 10 year ASCVD risk Moderate or high intensity statin When do I re check lipid levels, then? 4-12 weeks Goal is adherence, not response Who needs more advanced lipid testing? No one

4 Non statin drugs Because few trials have been performed with nonstatin cholesterol-lowering drugs in the statin era, and those that have were unable to demonstrate significant additional ASCVD event reductions in the RCT populations studied, there was less evidence to support the use of non-statin drugs Warning (personal opinion): There may be a role for non-statin drugs, but mostly for statin-intolerant patients. IMPROVE IT In ~18,000 post-acs patients over 7 years: Addition of ezetimibe to simvastatin 40 mg reduced the end point (composite of CV death, MI, unstable angina requiring rehospitalization, revascularization, or stroke) by 6.4% compared to simvastatin alone (P = 0.016) ARR = 2.0% (32.7% in ezetemibe/simvastatin vs. 34.7% in simvastatin only) o NNT = 50 *All-cause mortality was not affected accessed 11/24/ Wait. How many people are going to be on statins? % of U.S. Adults Eligible for Statins for Primary Prevention, According to Guidelines and Age As compared with ATP-III: Increase the number of U.S. adults eligible for statin therapy from 43.2 million (37.5%) to 56.0 million (48.6%) Mostly (10.4 million/12.8 million) in adults without ASCVD Among adults years without ASCVD, the percentage eligible for statins would increase: From 30.4% to 87.4% in men From 21.2% to 53.6% in women NEJM 2014, PMID: NEJM 2014, PMID:

5 Warning: opinion I am uncomfortable with any guideline that uses death as the only meaningful outcome Adverse events in RCTs per 100 statin-treated individuals: cases excess DM cases myopathy excess cases hemorrhagic stroke kg weight gain 4 JAMA Int Med 2014, PMID: ; Lancet 2013, PMID: ; JAMA 2014, PMID: ; JAMA 2014, PMID: ; 2 Lancet 2010, PMID: ; 3 Lancet PMID: ; 4 Lancet 2014, PMID: Where is the Gray Zone? [Guidelines] should not reduce physicians to automatons and patients to passive recipients of guideline dictums. That is, where is the risk range in which individual patient preferences/circumstances change the equation? Should 7.5% be a starting point for discussion? o For every 33 patients treated for 10 years, roughly one heart attack will be prevented o Number needed to treat = 33 The guideline notes that shared decision making should be used JAMA 2014, PMID: Am Fam Physician 2014, PMID:

6 How do I follow this quality measure? CMS have removed all three quality measures addressing LDL levels 1 o They have not been replaced with others Some have promoted engagement in shared decision-making rather than absolute numbers on meds 2 On Line Risk Calculators /home/www/cardiovascularrisk.html initiatives patient assessment instruments/pqrs/downloads/2015_medicare_physician_fee_schedule _proposed_rule_cms 1612 P.pdf, accessed 11/24/ JAMA 2014, PMID: PMID: year-old white woman Total cholesterol 175mg/dL HDL 54 mg/dl LDL 96 mg/dl BP 134 mmhg while taking lisinopril, 5 mg/d 10 year predicted risk = 7.7% 47-year-old African American man Total cholesterol 170 mg/dl HDL 45 mg/dl LDL 95mg/dL BP 129 mmhg while taking HCTZ 25 mg/d 10 year predicted risk = 7.5%

7 Conclusions: the good New guideline focuses on stroke and heart disease Focus is on effective meds Recognition of high intensity treatment needs of high-risk patients Conclusions: the bad The risk calculator probably overestimates risk The guideline draws a hard line at 7.5% 10-year risk, when this cutoff may be more appropriate for initiation of shared decision-making The end icecoldchickenwing@gmail.com facebook.com/doublearrowmetabolism 27 7

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