ACP Evidence Based Lipid Practice Case Rubric Case Study

2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/ NLA/PCNA Guideline on the Management of Blood Cholesterol: Executive Summary Citation This slide set is adapted from the 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/AP hA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol: Executive Summary. Published on [Date], available at: Journal of the American College of Cardiology [(insert full link)] and Circulation [(insert full link)] The full-text guidelines are also available on the following Web sites: ACC (www.acc.org) and AHA (professional.heart.org) 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, FNLA§ Chiadi E. Ndumele, MD, PhD, FAHA* Lynne T. Braun, PhD, CNP, FAHA, FPCNA, FNLA║ Carl E. Orringer, MD, FACC, FNLA║║ Sarah de Ferranti, MD, MPH* Carmen A. Peralta, MD, MAS* Joseph Faiella‐Tommasino, PhD, PA‐C¶ Joseph J. Saseen, PharmD, FNLA, FAHA¶¶ Daniel E. Forman, MD, FAHA** Sidney C. Smith, Jr, MD, MACC, FAHA* Ronald Goldberg, MD†† Laurence Sperling, MD, FACC, FAHA, FASPC*** Paul A. Heidenreich, MD, MS, FACC, FAHA‡‡ Salim S. Virani, MD, PhD, FACC, FAHA* Mark A. Hlatky, MD, FACC, FAHA* Joseph Yeboah, MD, MS, FACC, FAHA††† *ACC/AHA Representa ve. †AACVPR Representa ve. ‡ACC/AHA Task Force on Clinical Prac ce Guidelines Liaison. §Prevention Subcommittee Liaison. ║PCNA Representa ve. ¶AAPA Representa ve. **AGS Representa ve. ††ADA Representa ve. ‡‡PM Representa ve. §§ACPM Representative. ║║NLA Representa ve. ¶¶APhA Representa ve. ***ASPC Representa ve. †††ABC Representa ve Table 1. Applying Class of Recommendation and evel of Evidence to Clinical Strategies, Interventions, Treatments, or Diagnostic Testing in Patient Care* (Updated August 2015) Top 10 Take‐Home Messages 2018 Cholesterol Guidelines Top 10 Take Home Messages 1. In all individuals, emphasize a heart‐ healthy lifestyle across the life course. A healthy lifestyle reduces atherosclerotic cardiovascular disease (ASCVD) risk at all ages. In younger individuals, healthy lifestyle can reduce development of risk factors and is the foundation of ASCVD risk reduction. In young adults 20 to 39 years of age, an assessment of lifetime risk facilitates the clinician–patient risk discussion (see No. 6) and emphasizes intensive lifestyle efforts. In all age groups, lifestyle therapy is the primary intervention for metabolic syndrome. Top 10 Take Home Messages 2. In patients with clinical ASCVD, reduce low‐ density lipoprotein cholesterol (LDL‐C) with high‐intensity statin therapy or maximally tolerated statin therapy. The more LDL‐C is reduced on statin therapy, the greater will be subsequent risk reduction. Use a maximally tolerated statin to lower LDL‐C levels by ≥50%. Top 10 Take Home Messages 3. In very high‐risk ASCVD, use a LDL‐C threshold of 70 mg/dL (1.8 mmol/L) to consider addition of nonstatins to statin therapy. • • • Very high‐risk includes a history of multiple major ASCVD events or 1 major ASCVD event and multiple high‐risk conditions. In very high‐risk ASCVD patients, it is reasonable to add ezetimibe to maximally tolerated statin therapy when the LDL‐C level remains ≥70 mg/dL (≥1.8 mmol/L). In patients at very high risk whose LDL‐C level remains ≥70 mg/dL (≥1.8 mmol/L) on maximally tolerated statin and ezetimibe therapy, adding a PCSK9 inhibitor is reasonable, although the long‐term safety (>3 years) is uncertain and cost‐ effectiveness is low at mid‐2018 list prices. Top 10 Take Home Messages 4. In patients with severe primary hypercholesterolemia (LDL‐C level ≥ 190 mg/dL[≥4.9 mmol/L]) without calculating 10‐year ASCVD risk, begin high‐intensity statin therapy without calculating 10‐year ASCVD risk. •If the LDL‐C level remains ≥100 mg/dL (≥2.6 mmol/L), adding ezetimibe is reasonable • If the LDL‐C level on statin plus ezetimibe remains ≥100 mg/dL (≥2.6 mmol/L) & the patient has multiple factors that increase subsequent risk of ASCVD events, a PCSK9 inhibitor may be considered, although the long‐term safety (>3 years) is uncertain and economic value is low at mid‐2018 list prices. Top 10 Take Home Messages 5. In patients 40 to 75 years of age with diabetes mellitus and LDL‐C ≥70 mg/dL (≥1.8 mmol/L), start moderate‐intensity statin therapy without calculating 10‐year ASCVD risk. In patients with diabetes mellitus at higher risk, especially those with multiple risk factors or those 50 to 75 years of age, it is reasonable to use a high‐intensity statin to reduce the LDL‐C level by ≥50%. Top 10 Take Home Messages 6. In adults 40 to 75 years of age evaluated for primary ASCVD prevention, have a clinician–patient risk discussion before starting statin therapy. Risk discussion should include a review of major risk factors (e.g., cigarette smoking, elevated blood pressure, (LDL‐C), hemoglobin A1C [if indicated], and calculated 10‐year risk of ASCVD); • • • • • the presence of risk‐enhancing factors (see No. 8); the potential benefits of lifestyle and statin therapies; the potential for adverse effects and drug–drug interactions; the consideration of costs of statin therapy; and the patient preferences & values in shared decision‐making. Top 10 Take Home Messages 7. In adults 40 to 75 years of age without diabetes mellitus and with LDL‐C levels ≥70 mg/dL (≥1.8 mmol/L), at a 10‐year ASCVD risk of ≥7.5%, start a moderate‐intensity statin if a discussion of treatment options favors statin therapy. Risk‐enhancing factors favor statin therapy (see No. 8). If risk status is uncertain, consider using coronary artery calcium (CAC) to improve specificity (see No. 9). If statins are indicated, reduce LDL‐C levels by ≥30%, and if 10‐year risk is ≥20%, reduce LDL‐C levels by ≥50%. Top 10 Take Home Messages 8. In adults 40 to 75 years of age without diabetes mellitus and 10‐year risk of 7.5% to 19.9% (intermediate risk), risk‐ enhancing factors favor initiation of statin therapy (see No. 7). Risk‐enhancing factors include • family history of premature ASCVD; • persistently elevated LDL‐C levels ≥160 mg/dL (≥4.1 mmol/L); • metabolic syndrome; • chronic kidney disease; • history of preeclampsia or premature menopause (age <40 yrs) • chronic inflammatory disorders (e.g., rheumatoid arthritis, psoriasis, or chronic HIV); • high‐risk ethnic groups (e.g., South Asian); • persistent elevations of triglycerides ≥ 175 mg/dL (≥1.97 mmol/L); Top 10 Take Home Messages 8. In adults 40 to 75 years of age without diabetes mellitus and 10‐year risk of 7.5% to 19.9% (intermediate risk), risk‐ enhancing factors favor initiation of statin therapy (see No. 7). Risk‐enhancing factors include and, if measured in selected individuals • apolipoprotein B ≥130 mg/dL • high‐sensitivity C‐reactive protein ≥2.0 mg/L • ankle‐brachial index <0.9 and l • lipoprotein (a) ≥50 mg/dL or 125 nmol/L, especially at higher values of lipoprotein (a). Risk‐enhancing factors may favor statin therapy in patients at 10‐year risk of 5‐7.5% (borderline risk) Top 10 Take Home Messages 9. In adults 40 to 75 years of age without diabetes mellitus and with LDL‐C levels ≥70 mg/dL‐ 189 mg/dL (≥1.8‐4.9 mmol/L), at a 10‐year ASCVD risk of ≥7.5% to 19.9%, if a decision about statin therapy is uncertain, consider measuring CAC. • If CAC is zero, treatment with statin therapy may be withheld or delayed, except in cigarette smokers, those with diabetes mellitus, and those with a strong family history of premature ASCVD. • A CAC score of 1 to 99 favors statin therapy, especially in those ≥55 years of age. • For any patient, if the CAC score is ≥100 Agatston units or ≥75th percentile, statin therapy is indicated unless otherwise deferred by the outcome of clinician–patient risk discussion. Top 10 Take Home Messages 10. Assess adherence and percentage response to LDL‐ C–lowering medications and lifestyle changes with repeat lipid measurement 4 to 12 weeks after statin initiation or dose adjustment, repeated every 3 to 12 months as needed. • Define responses to lifestyle and statin therapy by percentage reductions in LDL‐C levels compared with baseline. • In ASCVD patients at very high‐risk, triggers for adding nonstatin drug therapy are defined by threshold LDL‐C levels ≥70 mg/dL (≥1.8 mmol/L) on maximal statin therapy (see No. 3). 2018 Cholesterol Guideline High Blood Cholesterol and ASCVD Measurements of LDL-C and Non-HDL-C Recommendations for Measurements of LDL‐C and Non‐HDL‐C COR LOE I B‐NR I B‐NR Recommendations In adults who are 20 years of age or older and not on lipid‐lowering therapy, measurement of either a fasting or a nonfasting plasma lipid profile is effective in estimating ASCVD risk and documenting baseline LDL‐C. In adults who are 20 years of age or older and in whom an initial nonfasting lipid profile reveals a triglycerides level of 400 mg/dL (≥4.5 mmol/L) or higher, a repeat lipid profile in the fasting state should be performed for assessment of fasting triglyceride levels and baseline LDL‐C. Measurements of LDL-C and Non-HDL-C Recommendations for Measurements of LDL‐C and Non‐HDL‐C COR LOE IIa C‐LD IIa C‐LD Recommendations For patients with an LDL‐C level less than 70 mg/dL (<1.8 mmol/L), measurement of direct LDL‐C or modified LDL‐C estimate is reasonable to improve accuracy over the Friedewald formula. In adults who are 20 years of age or older and without a personal history of ASCVD but with a family history of premature ASCVD or genetic hyperlipidemia, measurement of a fasting plasma lipid profile is reasonable as part of an initial evaluation to aid in the understanding and identification of familial lipid disorders. 2018 Cholesterol Guideline Patient Management Groups Secondary ASCVD Prevention Recommendations for Statin Therapy Use in Patients With ASCVD COR LOE Recommendations In patients who are 75 years of age or younger with clinical ASCVD,* high‐intensity statin therapy should be initiated or I A continued with the aim of achieving a 50% or greater reduction in LDL‐C levels. In patients with clinical ASCVD in whom high‐intensity statin therapy is contraindicated or who experience statin‐ I A associated side effects, moderate‐intensity statin therapy should be initiated or continued with the aim of achieving a 30% to 49% reduction in LDL‐C levels. Secondary ASCVD Prevention Recommendations for Statin Therapy Use in Patients With ASCVD COR LOE Recommendations In patients with clinical ASCVD who are judged to be very high risk and considered for PCSK9 inhibitor therapy, I B‐NR maximally tolerated LDL‐C lowering therapy should include maximally tolerated statin therapy and ezetimibe. In patients with clinical ASCVD who are judged to be very high risk and who are on maximally tolerated LDL‐C lowering therapy with LDL‐C 70 mg/dL (≥1.8 mmol/L) or higher or a SR IIa A non‐HDL‐C level of 100 mg/dL (≥2.6 mmol/L) or higher, it is reasonable to add a PCSK9 inhibitor following a clinician– patient discussion about the net benefit, safety, and cost. Secondary ASCVD Prevention Recommendations for Statin Therapy Use in Patients With ASCVD COR LOE Recommendations In patients with clinical ASCVD who are on maximally tolerated statin therapy and are judged to be at very high risk IIa B‐R and have an LDL‐C level of 70 mg/dL (≥1.8 mmol/L) or higher, it is reasonable to add ezetimibe therapy. At mid‐2018 list prices, PCSK9 inhibitors have a low cost Value value (>$150,000 per QALY) compared to good cost value Statement: (<$50,000 per QALY) (Section 7 provides a full discussion of Low Value the dynamic interaction of different prices and clinical (LOE: B‐NR) benefit). Secondary ASCVD Prevention Recommendations for Statin Therapy Use in Patients With ASCVD COR LOE Recommendations In patients older than 75 years of age with clinical ASCVD, it is reasonable to initiate moderate‐ or high‐intensity statin IIa B‐R therapy after evaluation of the potential for ASCVD risk reduction, adverse effects, and drug–drug interactions, as well as patient frailty and patient preferences. In patients older than 75 years of age who are tolerating high‐intensity statin therapy, it is reasonable to continue high‐intensity statin therapy after evaluation of the IIa C‐LD potential for ASCVD risk reduction, adverse effects, and drug‐drug interactions, as well as patient frailty and patient preferences. Secondary ASCVD Prevention Recommendations for Statin Therapy Use in Patients With ASCVD COR LOE Recommendations In patients with clinical ASCVD who are receiving maximally tolerated statin therapy and whose LDL‐C level remains 70 IIb B‐R mg/dL (≥1.8 mmol/L) or higher, it may be reasonable to add ezetimibe. In patients with heart failure (HF) with reduced ejection fraction attributable to ischemic heart disease who have a reasonable life expectancy (3 to 5 years) and are not already IIb B‐R on a statin because of ASCVD, clinicians may consider initiation of moderate‐intensity statin therapy to reduce the occurrence of ASCVD events. Secondary Prevention Table 4. Very High‐Risk* of Future ASCVD Events Major ASCVD Events Recent ACS (within the past 12 mo) History of MI (other than recent ACS event listed above) History of ischemic stroke Symptomatic peripheral arterial disease (history of claudication with ABI <0.85, or previous revascularization or amputation) Table 4 continued High‐Risk Conditions Age ≥65 y Heterozygous familial hypercholesterolemia History of prior coronary artery bypass surgery or percutaneous coronary intervention outside of the major ASCVD event(s) Diabetes mellitus Hypertension CKD (eGFR 15‐59 mL/min/1.73 m2) Current smoking Persistently elevated LDL‐C (LDL‐C ≥100 mg/dL [≥2.6 mmol/L]) despite maximally tolerated statin therapy and ezetimibe History of congestive HF Severe Hypercholesterolemia (LDL-C ≥190 mg/dL [≥4.9 mmol/L]) Recommendations for Primary Severe Hypercholesterolemia (LDL‐C ≥190 mg/dL [≥4.9 mmol/L]) COR LOE Recommendations In patients 20 to 75 years of age with an LDL‐C level of 190 I B‐R mg/dL (≥4.9 mmol/L) or higher, maximally tolerated statin therapy is recommended. In patients 20 to 75 years of age with an LDL‐C level of 190 mg/dL (≥4.9 mmol/L) or higher who achieve less than a IIa B‐R 50% reduction in LDL‐C while receiving maximally tolerated statin therapy and/or have an LDL‐C level of 100 mg/dL (≥2.6 mmol/L) or higher, ezetimibe therapy is reasonable. Severe Hypercholesterolemia (LDL-C ≥190 mg/dL [≥4.9 mmol/L]) Recommendations for Primary Severe Hypercholesterolemia (LDL‐C ≥190 mg/dL [≥4.9 mmol/L]) COR LOE Recommendations In patients 20 to 75 years of age with a baseline LDL‐C level ≥190 mg/dL (≥4.9 mmol/L), who achieve less than a 50% reduction in LDL‐C levels and have fasting triglycerides ≤300 IIb B‐R mg/dL (≤3.4 mmol/L). while taking maximally tolerated statin and ezetimibe therapy, the addition of a bile acid sequestrant may be considered. In patients 30 to 75 years of age with heterozygous FH and with an LDL‐C level of 100 mg/dL (≥2.6 mmol/L) or higher IIb B‐R while taking maximally tolerated statin and ezetimibe therapy, the addition of a PCSK9 inhibitor may be considered. Severe Hypercholesterolemia (LDL-C ≥190 mg/dL [≥4.9 mmol/L]) Recommendations for Primary Severe Hypercholesterolemia (LDL‐C ≥190 mg/dL [≥4.9 mmol/L]) COR LOE Recommendations In patients 40 to 75 years of age with a baseline LDL‐C level of 220 mg/dL (≥5.7 mmol/L) or higher and who achieve an on‐ IIb C‐LD treatment LDL‐C level of 130 mg/dL (≥3.4 mmol/L) or higher while receiving maximally tolerated statin and ezetimibe therapy, the addition of a PCSK9 inhibitor may be considered. Among patients with FH without evidence of clinical ASCVD Value taking maximally tolerated statin and ezetimibe therapy, Statement: PCSK9 inhibitors provide uncertain value at 2018 U.S. list Uncertain prices. Value (B‐NR) Diabetes Mellitus in Adults Recommendations for Patients With Diabetes Mellitus COR I IIa LOE Recommendations In adults 40 to 75 years of age with diabetes mellitus, A regardless of estimated 10‐year ASCVD risk, moderate‐ intensity statin therapy is indicated. In adults 40 to 75 years of age with diabetes mellitus and an LDL‐C level of 70 to 189 mg/dL (1.7 to 4.8 mmol/L), it is B‐NR reasonable to assess the 10‐year risk of a first ASCVD event by using the race and sex‐specific PCE to help stratify ASCVD risk. Diabetes Mellitus in Adults Recommendations for Patients With Diabetes Mellitus COR IIa IIa IIb LOE Recommendations In adults with diabetes mellitus who have multiple ASCVD B‐R risk factors, it is reasonable to prescribe high‐intensity statin therapy with the aim to reduce LDL‐C levels by 50% or more. In adults older than 75 years of age with diabetes mellitus B‐NR and who are already on statin therapy, it is reasonable to continue statin therapy. In adults with diabetes mellitus and 10‐year ASCVD risk of 20% or higher, it may be reasonable to add ezetimibe to C‐LD maximally tolerated statin therapy to reduce LDL‐C levels by 50% or more. Diabetes Mellitus in Adults Recommendations for Patients With Diabetes Mellitus COR IIb IIb LOE Recommendations In adults older than 75 years with diabetes mellitus, it may be C‐LD reasonable to initiate statin therapy after a clinician–patient discussion of potential benefits and risks. In adults 20 to 39 years of age with diabetes mellitus that is either of long duration (≥10 years of type 2 diabetes mellitus, ≥20 years of type 1 diabetes mellitus), albuminuria (≥30 mcg C‐LD of albumin/mg creatinine), estimated glomerular filtration rate (eGFR) less than 60 mL/min/1.73 m2, retinopathy, neuropathy, or ankle‐brachial index (ABI; <0.9), it may be reasonable to initiate statin therapy. Table 5. Diabetes‐Specific Risk Enhancers That Are Independent of Other Risk Factors in Diabetes Mellitus Risk Enhancers  Long duration (≥10 years for type 2 diabetes mellitus (S.4.3‐20) or ≥20 years for type 1 diabetes mellitus)  Albuminuria ≥30 mcg of albumin/mg creatinine  eGFR <60 mL/min/1.73 m2  Retinopathy  Neuropathy  ABI <0.9 Table 6. Risk‐Enhancing Factors for Clinician–Patient Risk Discussion Risk‐Enhancing Factors        Family history of premature ASCVD (males, age <55 y; females, age <65 y) Primary hypercholesterolemia (LDL‐C, 160–189 mg/dL [4.1–4.8 mmol/L); non–HDL‐ C 190–219 mg/dL [4.9–5.6 mmol/L])* Metabolic syndrome (increased waist circumference, elevated triglycerides [>175 mg/dL], elevated blood pressure, elevated glucose, and low HDL‐C [<40 mg/dL in men; <50 in women mg/dL] are factors; tally of 3 makes the diagnosis) Chronic kidney disease (eGFR 15–59 mL/min/1.73 m2 with or without albuminuria; not treated with dialysis or kidney transplantation) Chronic inflammatory conditions such as psoriasis, RA, or HIV/AIDS History of premature menopause (before age 40 y) and history of pregnancy‐ associated conditions that increase later ASCVD risk such as preeclampsia High‐risk race/ethnicities (e.g., South Asian ancestry) Table 6 continued Risk‐Enhancing Factors  Lipid/biomarkers: Associated with increased ASCVD risk o Persistently* e …
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