Disclosure Dr. Saseen has no financial disclosures or conflicts of - PDF document

1/12/2019 Hot off the Press: New ACC-AHA Cholesterol Guidelines Joseph Saseen, PharmD Professor and Vice Chair, Department of Clinical Pharmacy Professor, Department of Family Medicine University of Colorado Anschutz Medical Campus Disclosure • Dr. Saseen has no financial disclosures or conflicts of interest 1

1/12/2019 Learning Objectives Pharmacist Technician • Explain the 2018 ACC-AHA • Identify moderate-intensity and Cholesterol Guideline high-intensity statin doses • recommendations for statin therapy List patient populations that • Differentiate when a nonstatin benefit from statin therapy • medication should be added to statin Compare different way to in a patient with hypercholesterolemia identify whether a patient is • Discuss recommendations for adherent with statin therapy implementation of therapy in patients with hypercholesterolemia • Apply new cholesterol guideline recommendations to create a treatment plan for a patient presenting with hypercholesterolemia ACC-AHA 2013 Blood Cholesterol Guideline High-intensity statin if aged ≤75 yrs Moderate-intensity statin if aged >75 yrs or not Clinical ASCVD candidate for high-intensity LDL- C ≥ 190 mg/dL High-intensity statin Moderate-intensity statin Diabetes Aged 40-75 yrs High-intensity statin if 10-year ASCVD risk ≥7.5% ≥7.5 % 10-yr ASCVD risk Moderate-to-high intensity statin A ged 40-75 yrs Stone NJ et al. Circulation . 2014;129(25 suppl 2):S1-S45. 2

1/12/2019 Evolution of Guidelines and Landmark Trials NCEP NCEP NCEP NCEP ACC/AHA, ACC/AHA ATP I ATP II ATP III ATP III 1988 1993 2001 2004 2013 2018 Expanded/Modified Treatment Recommendations Framingham FATS, 4S HPS TNT HOPE-3 MRFIT POSCH, WOSCOPS PROVE-IT IDEAL IMPROVE-IT LRC-CPPT SCORE, CARE ASCOT-LLA ACCORD FOURIER Helsinki STARTS, LIPID PROSPER JUPITER ODYSSEY Heart Ornish, MARS, AFCAPS/ ALLHAT-LLT CTT Meta- Coronary Meta-analyses TexCAPS analyses Drug Project (Holmes ENHANCE CLAS Rossouw) SHARP VA-HIT AURORA CORONA AIM HIGH NCEP ATP = National Cholesterol Education Panel Adult Treatment Panel HPS2-Thrive AHA = American Heart Association ACC = American College of Cardiology AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ ASPC/ NLA/PCNA Guideline on the Management of Blood Cholesterol 2018 Cholesterol Guideline Writing Committee Scott M. Grundy, MD, PhD, FAHA, Chair, Neil J. Stone, MD, FACC, FAHA, Vice Chair Alison L. Bailey, MD, FACC, FAACVPR† Daniel W. Jones, MD, FAHA § Craig Beam, CRE* Donald Lloyd-Jones, MD, SCM, FACC, FAHA* Kim K. Birtcher, MS, PharmD, AACC, FNLA‡ Nuria Lopez-Pajares, MD, MPH §§ Roger S. Blumenthal, MD, FACC, FAHA, Chiadi E. Ndumele, MD, PhD, FAHA* FNLA § Carl E. Orringer, MD, FACC, FNLA║║ Lynne T. Braun, PhD, CNP, FAHA, FPCNA, Carmen A. Peralta, MD, MAS* FNLA║ Joseph J. Saseen, PharmD, FNLA, FAHA¶¶ Sarah de Ferranti, MD, MPH* Sidney C. Smith, Jr, MD, MACC, FAHA* Joseph Faiella-Tommasino, PhD, PA-C¶ Laurence Sperling, MD, FACC, FAHA, Daniel E. Forman, MD, FAHA** FASPC*** Ronald Goldberg, MD †† Salim S. Virani, MD, PhD, FACC, FAHA* Paul A. Heidenreich, MD, MS, FACC, FAHA ‡‡ Joseph Yeboah, MD, MS, FACC, FAHA ††† Mark A. Hlatky, MD, FACC, FAHA* *ACC/AHA Representative. †AACVPR Representative. ‡ACC/AHA Task Force on Clinical Practice Guidelines Liaison. § Prevention Subcommittee Liaison. ║PCNA Representative. ¶AAPA Representative. **AGS Representative. ††ADA Representative. ‡‡PM Representative. §§ ACPM Representative. ║║NLA Representative. ¶¶ APhA Representative. ***ASPC Representative. †††ABC Representative Grundy SM, et al. J Am Col Cardiol 2018. doi: https://doi.org/10.1016/j.jacc.2018.11.003. 3

1/12/2019 Clinical Scenario... You are required to provide a 20 minute presentation to the clinical pharmacy staff at your health-system on the 2018 ACC-AHA Guideline on the Management of Blood Cholesterol. You had 2 weeks to prepare, but you got behind and your slides are due tomorrow. Which is the most accurate source of information and resources about this new guideline? a) The chief cardiologist at your health-system b) Class notes from the PharmD student that is on rotation with you c) The Blog called Statin Nation (http://www.statinnation.net/blog/) d) Interview of Dr. Oz on YouTube e) ACC Cholesterol Guideline Hub ACC Cholesterol Guideline Hub • http://www.onlinejacc.org/guidelines/cholesterol 4

1/12/2019 Evidence-Based Recommendations Level (Quality) of Evidence Class (Strength) of Recommendation Level A Class I (Strong) Benefit >>> Risk High-quality evidence from > one randomized clinical trial (RCT) • Is recommended, is indicated, should be performed • • Meta-analyses of high-quality RCTs Class IIa (Moderate) Benefit >> Risk Level B-R (Randomized) • Is reasonable, can be useful • Moderate-quality evidence from > one RCT Class IIb (Weak) Benefit ≥ Risk • Meta-analyses of moderate-quality RCTs • May/might be reasonable/considered, effectiveness unknown Level B-NR (Nonrandomized) Class III: No Benefit (Moderate) Benefit = Risk • Moderate-quality from nonrandomized studies, observational, registry Is not recommended, is not useful • Level C-LD (Limited Data) Class III: Harm (Strong) Benefit < Risk Level C-EO (Expert Opinion) • Potentially harmful, causes harm Grundy SM, et al. J Am Col Cardiol 2018. doi: https://doi.org/10.1016/j.jacc.2018.11.003. Top 10 Messages 1. Emphasize a heart-healthy lifestyle across 7. 40 to 75 years of age without diabetes and LDL- C ≥70 mg/ dL, at a 10-year the life course ASCVD risk of ≥7.5%, start a moderate - 2. In clinical ASCVD, reduce LDL-C with high-intensity statin therapy or maximally intensity statin if a discussion of treatment tolerated statin therapy options favors statin therapy 8. 40 to 75 years of age without diabetes 3. In very high-risk ASCVD, use a LDL-C threshold of 70 mg/dL to consider addition and 10-year risk of 7.5-19.9% of nonstatins to statin therapy (intermediate risk), risk-enhancing factors 4. In severe primary hypercholesterolemia favor statin therapy (LDL- C ≥ 190 mg/ dL) without calculating 9. 40 to 75 years of age without diabetes 10-year ASCVD risk, begin high-intensity and LDL-C 70-189 mg/dL, at a 10-year statin therapy ASCVD risk of 7.5-19.9%, if a decision about statin therapy is uncertain, consider 5. 40 to 75 years of age with diabetes mellitus and LDL- C ≥70 mg/ dL, start measuring coronary artery calcium 10.Assess adherence and % LDL-C – moderate-intensity statin therapy without calculating 10-year ASCVD risk lowering response with repeat lipid measurement 4 to 12 weeks after statin 6. 40 to 75 years of age primary ASCVD prevention, have a clinician – patient risk initiation or dose adjustment, repeated discussion before starting statin therapy every 3 to 12 months as needed Grundy SM, et al. J Am Col Cardiol 2018. doi: https://doi.org/10.1016/j.jacc.2018.11.003. 5

1/12/2019 The DEVIL is in the DETAILS … Clarifying Terminology Goals… Threshold… a specific value for for LDL-C lowering LDL-C (or non-HDL- in response to C) at or above which therapy are defined clinicians should by percentage consider starting or responses intensifying therapy Grundy SM, et al. J Am Col Cardiol 2018. doi: https://doi.org/10.1016/j.jacc.2018.11.003. 6

1/12/2019 True of False… The new 2018 ACC-AHA guidelines are similar to the 2013 guidelines in regards to still recommending statin therapy in the previously defined four statin benefit groups? True False Clinical ASCVD Yes No Secondary Prevention (age ≥18 yr) Primary Prevention (age 40-75 yr) LDL-C LDL-C 70-189 mg/dL LDL-C History of multiple ASCVD events ≥190 mg/ dL <70 mg/dL or Diabetes Yes 1 major ASCVD event plus multiple high-risk conditions Assess No Lifetime 10-yr ASCVD risk Risk Yes No ≥20% ≥7.5 to 19.9% 5 to 7.4% <5% Very High Stable (High) (Intermediate) (Borderline) (Low) Risk ASCVD ASCVD Evaluate Risk Risk Discussion Enhancers and for statin benefit; CAC score if consider Risk uncertain Enhancers High- or Moderate- Lifestyle; High- High- High- Moderate- Lifestyle Intensity Moderate- Selective Intensity/ Intensity/ Intensity Intensity and risk Intensity Statin; Moderate- Maximal Maximal Statin Statin discussion Statin High-Intensity Intensity Statin Statin Statin if elevated ASCVD risk ASCVD = atherosclerotic cardiovascular disease; CAC = coronary artery calcium Grundy SM, et al. J Am Col Cardiol 2018. doi: https://doi.org/10.1016/j.jacc.2018.11.003. 7