Hot off the Press: New ACC-AHA Cholesterol Guidelines - Alaska Pharmacists ...

 
Hot off the Press: New ACC-AHA Cholesterol Guidelines - Alaska Pharmacists ...
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

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Hot off the Press: New ACC-AHA Cholesterol Guidelines - Alaska Pharmacists ...
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
                            Clinical ASCVD                  Moderate-intensity statin if aged >75 yrs or not
                                                            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
                          Aged 40-75 yrs

Stone NJ et al. Circulation. 2014;129(25 suppl 2):S1-S45.

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Hot off the Press: New ACC-AHA Cholesterol Guidelines - Alaska Pharmacists ...
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.

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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

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                      Evidence-Based Recommendations
           Class (Strength) of Recommendation                                                           Level (Quality) of Evidence

   Class I (Strong)                                       Benefit >>> Risk                  Level A
   •    Is recommended, is indicated, should be performed                                   •   High-quality evidence from > one randomized clinical trial (RCT)
                                                                                            •   Meta-analyses of high-quality RCTs
   Class IIa (Moderate)                                      Benefit >> Risk
   •    Is reasonable, can be useful                                                        Level B-R                                        (Randomized)
                                                                                            •   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
   •    Potentially harmful, causes harm                                                    Level C-EO                                   (Expert Opinion)

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
            the life course                                                                     and LDL-C ≥70 mg/dL, at a 10-year
         2. In clinical ASCVD, reduce LDL-C with                                                ASCVD risk of ≥7.5%, start a moderate-
            high-intensity statin therapy or maximally                                          intensity statin if a discussion of treatment
            tolerated statin therapy                                                            options favors statin therapy
         3. In very high-risk ASCVD, use a LDL-C                                            8. 40 to 75 years of age without diabetes
            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
         5. 40 to 75 years of age with diabetes                                                 about statin therapy is uncertain, consider
            mellitus and LDL-C ≥70 mg/dL, start                                                 measuring coronary artery calcium
            moderate-intensity statin therapy without                                       10. Assess adherence and % LDL-C–
            calculating 10-year ASCVD risk                                                      lowering response with repeat lipid
         6. 40 to 75 years of age primary ASCVD                                                 measurement 4 to 12 weeks after statin
            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.

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1/12/2019

               The DEVIL
                   is in the
                     DETAILS…

                                                 Clarifying Terminology

                                      Goals…                                                   Threshold…

                    for LDL-C lowering                                                       a specific value for
                                                                                            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
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            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)

     History of multiple ASCVD events                                         LDL-C                                      LDL-C 70-189 mg/dL                               LDL-C
                      or                                                    ≥190 mg/dL
1/12/2019

                            Secondary Prevention of ASCVD
                                                                                                Clinical ASCVD

                                                                                              Healthy Lifestyle
                                                                                      No        Very High-Risk         Yes

                 Age ≤75 yr                                           Age >75 yr                                  High-intensity/maximal statin [Class I]

         High-intensity statin
                                                                                                           If on maximal          If PCSK9i is        Randomized
      (Goal ↓LDL-C 50%) [Class I]
                                                                                                         statin and LDL-C         considered,          controlled
                                                                                                         ≥70 mg/dL adding        add ezetimibe            study
                                                                                                            ezetimibe is           to maximal           support,
                                                                                                             reasonable             statin first      but less cost
                               If on maximal                                                                  [Class IIa]            [Class I]          effective
        If high-                                           Moderate              Continuing
                              statin and LDL-
     intensity not                                           or high-                high-
                               C ≥70 mg/dL
    tolerated use                                           intensity              intensity
                                    adding
      moderate-                                              statin is              stain is               If on clinically judged-maximal LDL-C lowering
                              ezetimibe may
   intensity statin                                       reasonable             reasonable             medication and LDL-C ≥70 mg/dL (or non-HDL-C ≥100
                              be reasonable
       [Class I]                                           [Class IIa]            [Class IIa]             mg/dL adding a PCSK9i is reasonable [Class IIa]
                                  [Class Ilb]

Grundy SM, et al. J Am Col Cardiol 2018. doi: https://doi.org/10.1016/j.jacc.2018.11.003.

                                                            Very High ASCVD
                                                                                            Major ASCVD Events
                                             •     Recent acute coronary syndrome (past 12 mo)
                                             •     Prior myocardial infarction (other than recent ACS event listed above)
                                             •     Prior ischemic stroke
     History of                              •     Symptomatic peripheral arterial disease
   multiple major
   ASCVD events                                                                             High-Risk Conditions
                                             •     Age ≥65 yr
         or                                  •     Heterozygous familial hypercholesterolemia
   1 major ASCVD                             •     Prior coronary revascularization outside of the major ASCVD event(s)
     event and                               •     Diabetes mellitus
      multiple                               •     Hypertension
      high-risk                              •     Chronic kidney disease (eGFR 15-59 mL/min/1.73 m2)
                                             •     Current smoking
     conditions                              •     LDL-C ≥100 mg/dL despite maximally tolerated statin and ezetimibe
                                             •     History of congestive heart failure

Grundy SM, et al. J Am Col Cardiol 2018. doi: https://doi.org/10.1016/j.jacc.2018.11.003.

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                                                                 Statin Intensity
                                           High Intensity                                   Moderate Intensity                                    Low Intensity
         LDL-C*
                                                     ≥50%                                                                         30 to 49%
1/12/2019

                                                 Other Recommendations:
                                                  Secondary Prevention
            COR                  LOE                                                        Recommendations
                Value
                        At mid-2018 list prices, PCSK9i have a low cost value
             Statement:
                        (>$150,000 per QALY) compared to good cost value
             Low Value
                        (
1/12/2019

                                                            Clinical ASCVD
                                            Yes                                                 No

 Secondary Prevention (age ≥18 yr)                                                                                  Primary Prevention (age 40-75 yr)

     History of multiple ASCVD events                                         LDL-C                                             LDL-C 70-189 mg/dL                                   LDL-C
                      or                                                    ≥190 mg/dL
1/12/2019

          Other Recommendations: Primary Prevention
                  Severe Hypercholesterolemia (LDL-C ≥190 mg/dL)
           COR                   LOE                                                         Recommendations
                                                    20 to 75 yr,
1/12/2019

             When to use High-Intensity Statin therapy in
             Primary Prevention Patients with Diabetes?

           “In patients with diabetes mellitus at higher risk, especially those
                with multiple risk factors or those 50 to 75 years of age”

                “Adults with diabetes mellitus who have multiple ASCVD risk
                                            factors”

               “among men >50 years of age and women >60 years of age”

               “in patients with diabetes mellitus as they age or develop risk
                                          modifiers”
Grundy SM, et al. J Am Col Cardiol 2018. doi: https://doi.org/10.1016/j.jacc.2018.11.003.

                                     Other Recommendations:
                                  Primary Prevention and Diabetes
           COR                 LOE                                  Recommendations
                                               40-75 yr with diabetes and multiple ASCVD risk factors,
              IIa              B-R             high-intensity statin therapy is reasonable with the aim to
                                               reduce LDL-C ≥50%

                                               >75 yr with diabetes and already on statin therapy,
              IIa            B-NR
                                               reasonable to continue

                                   40-75 yr with diabetes and 10-year ASCVD risk ≥20%,
              IIb             C-LD reasonable to add ezetimibe to maximally tolerated statin
                                   therapy to reduce LDL-C ≥50%

Grundy SM, et al. J Am Col Cardiol 2018. doi: https://doi.org/10.1016/j.jacc.2018.11.003.

                                                                                                                   13
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                                     Other Recommendations:
                                  Primary Prevention and Diabetes
           COR                  LOE                                                         Recommendations
                                                >75 years with diabetes, reasonable to initiate statin
              IIb               C-LD
                                                therapy after benefit/risk discussion
                                                20 to 39 yr with diabetes reasonable to initiate statin
                                                therapy if diabetes-specific risk enhancer present:
                                                   •     long duration (≥10 yr for type 2, ≥20 yr for type 1)
              IIb               C-LD               •     albuminuria (≥30 mcg of albumin/mg creatinine),
                                                   •     eGFR < 60 mL/min/1.73 m2
                                                   •     retinopathy
                                                   •     neuropathy
                                                   •     ankle-brachial index
1/12/2019

                                               Risk Enhancing Factors
         • Family history of premature                                                      • Chronic inflammatory conditions
           ASCVD                                                                              (e.g., rheumatoid arthritis, HIV)

         • LDL-C 160–189 mg/dL or non–                                                      • Premature menopause (before
           HDL-C 190–219 mg/dL                                                                age 40 y) and pregnancy-
                                                                                              associated conditions that
         • Metabolic syndrome                                                                 increase later ASCVD risk (e.g.,
                                                                                              preeclampsia)
         • CKD
                  • eGFR 15–59 mL/min/1.73 m2                                               • High-risk race/ethnicities (e.g.,
                    with or without albuminuria)                                              South Asian ancestry)
                  • not dialysis or kidney
                    transplantation
Grundy SM, et al. J Am Col Cardiol 2018. doi: https://doi.org/10.1016/j.jacc.2018.11.003.

                                  Risk Enhancing Factors, cont.
         • Lipid/biomarkers:
                   – Persistently elevated, primary hypertriglyceridemia (≥175 mg/dL)

         • In select individuals, If measured:
                   –      High-sensitivity C-reactive protein ≥2.0 mg/L
                   –      Lp(a) ≥50 mg/dL
                   –      apoB ≥130 mg/dL
                   –      Ankle brachial index
1/12/2019

                                                Other Recommendations:
                    Primary Prevention, without Diabetes, LDL-C 70-189 mg/dL

           COR                 LOE                                                          Recommendations
                                                Intermediate-risk or selected borderline-risk in whom
                                                a coronary artery calcium (CAC) score is measured:
                                                  • Zero:                       reasonable to withhold statin therapy and
                                                                                reassess in 5 to 10 years, as long as higher risk
               IIa             B-NR                                             conditions are absent (diabetes, family history of
                                                                                premature CHD, cigarette smoking)
                                                  • 1 to 99:                    reasonable to initiate statin therapy for patients
                                                                                ≥55 years of age
                                                  • ≥100*:                      reasonable to initiate statin therapy

                                                                                                               *or ≥ 75th percentile

Grundy SM, et al. J Am Col Cardiol 2018. doi: https://doi.org/10.1016/j.jacc.2018.11.003.

               Coronary Artery Calcium Measurement
         Patients Who Might Benefit from Knowing Their CAC
         Score Is Zero
          Reluctant to initiate statin therapy and wish to
           understand their risk/benefit more precisely
          Concerned about need to reinstitute statin after stopping
           for SAMS
          Older patients (men, 55-80 yr; women, 60-80 yr) with low
           burden of risk factors who are uncertain
          Middle-aged patients (40-55 yr) with 10-yr ASCVD risk 5
           to 7.4% with other factors that increase ASCVD risk
Grundy SM, et al. J Am Col Cardiol 2018. doi: https://doi.org/10.1016/j.jacc.2018.11.003.

                                                                                                                                             16
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                                                Other Recommendations:
                    Primary Prevention, without Diabetes, LDL-C 70-189 mg/dL

           COR                 LOE                                                          Recommendations

              IIb               B-R             >75 yr, moderate-intensity statin may be reasonable

                                                >75 yr, reasonable to stop statin therapy when functional
                                                decline (physical or cognitive), multimorbidity, frailty, or
              IIb               B-R
                                                reduced life-expectancy limits the potential benefits of
                                                statin therapy
                                                76 to 80 yr, reasonable to measure CAC to reclassify
              IIb               B-R
                                                those with a CAC score of zero to avoid statin therapy

Grundy SM, et al. J Am Col Cardiol 2018. doi: https://doi.org/10.1016/j.jacc.2018.11.003.

                 Statin-Associated Side Effects:
          Statin-Associatied Muscle Symptoms (SAMS)
                            Type                               Frequency                     Predisposing Factors                      Evidence
                                                              • Infrequent (1%              Age, female sex, low body mass          RCTs,
                                                                to 5%) in RCT               index, high-risk medications            cohorts/observational
                                                              • Frequent (5% to             (CYP3A4 inhibitors, OATP1B1
         Myalgias
                                                                10%) in                     inhibitors), comorbidities (HIV, renal,
         (CK Normal)                                            observational               liver, thyroid, preexisting myopathy),
                                                                studies and                 Asian ancestry, excess alcohol, high
                                                                clinical setting            levels of physical activity, and trauma
         Myositis/myopathy                                    Rare                                                                 RCTs,
         (CK > ULN) with concerning                                                                                                cohorts/observational
         symptoms or objective
         weakness
         Rhabdomyolysis               Rare                                                                                         RCTs,
         (CK >10× ULN + renal injury)                                                                                              cohorts/observational

         Statin-associated                                    Rare                                                                 Case Reports
         autoimmune myopathy

Grundy SM, et al. J Am Col Cardiol 2018. doi: https://doi.org/10.1016/j.jacc.2018.11.003.

                                                                                                                                                                  17
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                   Statin-Associated Side Effects: Other
                   Type                                       Frequency                     Predisposing                                 Evidence
                                                                                               Factors
                                           Depends on population;                           Diabetes                         RCTs/meta-analyses
                                           more frequent if diabetes mellitus               mellitus risk
         New-Onset                         risk factors are present, such as                factors/
         Diabetes                          body mass index ≥30, fasting                     metabolic
         Mellitus                          blood sugar ≥100 mg/dL;                          syndrome, High-
                                           metabolic syndrome, or A1c ≥6%                   dose statin
                                                                                            therapy
         Transaminase                      Infrequent                                                                        RCTs,
         Elevation                                                                                                           cohorts/observational,
         (3× ULN)                                                                                                            case reports
         Hepatic Failure Rare

Grundy SM, et al. J Am Col Cardiol 2018. doi: https://doi.org/10.1016/j.jacc.2018.11.003.        Grundy SM, et al. J Am Col Cardiol 2018. doi: https://doi.org/10.1016/j.jacc.2018.11.003.

                  Statin-Associated Side Effects: Myths

                                 Type                                     Frequency                      Evidence
                                                                      Rare/unclear              Case reports;
         Memory/cognition
                                                                                                no increase in 3 large RCTs
                                                                      No definite               RCTs/meta-analyses
         Cancer
                                                                      association
         Renal Dysfunction,                                           Unclear/Unfounded
         Tendon Rupture,
         Interstitial lung disease,
         Low testosterone
         Cataracts,                 Unclear
         Hemorrhagic stroke
Grundy SM, et al. J Am Col Cardiol 2018. doi: https://doi.org/10.1016/j.jacc.2018.11.003.

                                                                                                                                                                                             18
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                         2018 ACC-AHA Cholesterol Guideline:
                           Statin Safety Recommendations

           COR                   LOE                                        Recommendations
                                                   A clinician–patient risk discussion is recommended before
                                                   initiation of statin therapy to review net clinical benefit,
                                                   weighing the potential for ASCVD risk reduction against the
                I                   A
                                                   potential for statin-associated side effects, statin–drug
                                                   interactions, and safety, while emphasizing that side
                                                   effects can be addressed successfully
                                                   In patients with statin-associated muscle symptoms (SAMS), a
                I                                  thorough assessment of symptoms is recommended, in
                                    A
                                                   addition to an evaluation for nonstatin causes and
                                                   predisposing factors

Grundy SM, et al. J Am Col Cardiol 2018. doi: https://doi.org/10.1016/j.jacc.2018.11.003.

                         2018 ACC-AHA Cholesterol Guideline:
                           Statin Safety Recommendations

           COR                   LOE                                                        Recommendations
                                                   In patients with indication for statin therapy, identification of potential
                I                 B-R              predisposing factors for statin-associated side effects, including newonset
                                                   diabetes mellitus and SAMS, is recommended before initiation of treatment
                                                   In patients with statin-associated side effects that are not severe, it is
                                                   recommended to reassess and to rechallenge to achieve a maximal LDL-
                I                 B-R              C lowering by modified dosing regimen, an alternate statin or in
                                                   combination with nonstatin therapy
                                                   In patients with increased diabetes mellitus risk or new-onset diabetes
                                                   mellitus, it is recommended to continue statin therapy, with added
                I                 B-R              emphasis on adherence, net clinical benefit, and the core principles of
                                                   regular moderate-intensity physical activity, maintaining a healthy dietary
                                                   pattern, and sustaining modest weight loss

Grundy SM, et al. J Am Col Cardiol 2018. doi: https://doi.org/10.1016/j.jacc.2018.11.003.

                                                                                                                                   19
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                         2018 ACC-AHA Cholesterol Guideline:
                           Statin Safety Recommendations

           COR                   LOE                                                        Recommendations
                                                   In patients treated with statins, it is recommended to measure creatine
                                                   kinase levels in individuals with severe statin-associated muscle
                I               C-LD               symptoms, objective muscle weakness, and to measure liver
                                                   transaminases (AST/ALT) as well as total bilirubin and alkaline
                                                   phosphatase (hepatic panel) if symptoms suggesting hepatotoxicity
                                                   In patients at increased ASCVD risk with chronic, stable liver disease
                                                   (including non-alcoholic fatty liver disease) when appropriately indicated, it
                I                 B-R              is reasonable to use statins after obtaining baseline measurements and
                                                   determining a schedule of monitoring and safety checks
                                                   In patients at increased ASCVD risk with severe statin-associated muscle
                                                   symptoms or recurrent statin-associated muscle symptoms despite
              IIa                 B-R              appropriate statin rechallenge, it is reasonable to use RCT proven
                                                   nonstatin therapy that is likely to provide net clinical benefit

Grundy SM, et al. J Am Col Cardiol 2018. doi: https://doi.org/10.1016/j.jacc.2018.11.003.

                         2018 ACC-AHA Cholesterol Guideline:
                           Statin Safety Recommendations

             COR                   LOE                                                      Recommendations
            III:                       Coenzyme Q10 is not recommended for routine use
            No                    B-R in patients treated with statins or for the treatment of
          Benefit                      SAMS
            III:                       In patients treated with statins, routine
            No                    C-LD measurements of creatine kinase and transaminase
          Benefit                      levels are not useful

Grundy SM, et al. J Am Col Cardiol 2018. doi: https://doi.org/10.1016/j.jacc.2018.11.003.

                                                                                                                                      20
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                             Noteworthy Additional Elements
         • In patients treated with dialysis, it reasonable to continue
           statin therapy, but do not initiate statin therapy
         • In patients with heart failure with reduced ejection
           fraction attributable to ischemic heart disease who have
           a reasonable life expectancy (3 to 5 years) and are not
           already on a statin because of ASCVD, clinicians may
           consider initiation of moderate-intensity statin therapy to
           reduce the occurrence of ASCVD events

Grundy SM, et al. J Am Col Cardiol 2018. doi: https://doi.org/10.1016/j.jacc.2018.11.003.

                             Noteworthy Additional Elements
         • Recommendations for certain populations:
                   – Women, children and adolescents, racial/ethnic groups, CKD,
                     chronic inflammatory diseases
         • Interventions to improve adherence are recommended,
           including telephone reminders, calendar reminders,
           integrated multidisciplinary educational activities, and
           pharmacist-led interventions
         • Supplemental tables regarding medications

Grundy SM, et al. J Am Col Cardiol 2018. doi: https://doi.org/10.1016/j.jacc.2018.11.003.

                                                                                                  21
1/12/2019

                            Case 1
• HB is a 50-year-old African American woman who has a
  history of hypertension and hypercholesterolemia. Her only
  medications are olmesartan 40 mg po daily and amlodipine
  10 mg po daily. She weighs 188 lbs, and is 65" tall (BMI is
  31.3 kg/m2).
• While measuring her BP (136/82, 138/82 mm Hg), she tells
  you that her mother also had hypertension and suddenly died
  of a heart attack when she was 55-years-old.
• She smokes cigarettes (1-ppd x 40 years) and drinks alcohol
  rarely.
• Other than hypertension and hypercholesterolemia, she is
  relatively health and is post-menopausal (menopause at age
  35 yr).

                 Case 1 continued…
• Over the past year, she has lost 10 pounds by exercising
  three times a week (aerobic) and eating better after
  working with a dietitian. However, she feels like her
  efforts have plateaued.
• Recent laboratory values are:
   – Fasting Lipid Panel:
      • Total cholesterol 225 mg/dL
      • HDL-C             40 mg/dL
      • LDL-C             135 mg/dL
      • Triglycerides     200 mg/dL
   – A1C           6%
   – Serum chemistries and liver function tests are normal

                                                                      22
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       Case 1 continued…

       Case 1 continued…

    How would you treat this
patient’s hypercholesterolemia?

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                                                        Primary Prevention
                                     Primary Prevention:                                                         LDL-C ≥190 mg/dL, risk assessment not needed:
      Assess ASCVD risk and emphasize adherence to healthy lifestyle                                                      High-intensity statin [Class I]
                                                                                                                             Diabetes, age 40-75 yrs:
                                                                                                                          Moderate-intensity statin [Class I]
         Age 75 yr:
      hypercholesterolemia                                                                                               Clinical assessment, risk discussion
                                       and LDL-C 160-189 mg/dL                   begins discussion
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                                                                 Statin Intensity
                                           High Intensity                                   Moderate Intensity             Low Intensity
         LDL-C*
                                                     ≥50%                                       30 to 49%
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                         Checklist for Clinician-Patient Shared
                         Decision Making for Initiating Therapy
        ASCVD Risk Assessment
        Lifestyle Modifications
        Potential Net-Clinical Benefit from Pharmacotherapy
        Cost Considerations
        Shared Decision Making
               • Have patient verbalize what was heard, ask questions, express preferences
               • Refer patient to trustworthy materials to aid understanding
               • Collaborate with the patient to determine ultimate plan

Grundy SM, et al. J Am Col Cardiol 2018. doi: https://doi.org/10.1016/j.jacc.2018.11.003.

                                                                   Implementation
          COR                LOE                                                            Recommendations
                                              Interventions focused on improving adherence to prescribed therapy are
                                              recommended for management of adults with elevated cholesterol
               I                  A           levels, including telephone reminders, calendar reminders, integrated
                                              multidisciplinary educational activities, and pharmacist-led interventions,
                                              such as simplification of the drug regimen to once-daily dosing
                                              Clinicians, health systems, and health plans should identify patients who
                                              are not receiving guideline-directed medical therapy and should facilitate
               I               B-R
                                              the initiation of appropriate guideline-directed medical therapy, using
                                              multifaceted strategies to improve guideline implementation
                                              Before therapy is prescribed, a patient-clinician discussion should take
                                              place to promote shared decision-making and should include the
               I               B-R
                                              potential for ASCVD risk-reduction benefit, adverse effects, drug-drug
                                              interactions, and patient preferences

Grundy SM, et al. J Am Col Cardiol 2018. doi: https://doi.org/10.1016/j.jacc.2018.11.003.

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                                      Strategies to Improve Guideline
                                              Implementation
                                                                                                                          Retail                Office/
                Patient                              Clinician                              Health Plan                 Pharmacy             Health System
     • Simple medication                      • Initiate patient-                 • Embed decision support          • Reduce costs of        • Automated refill
       regimens                                 clinician discussions               tools into electronic health      guideline directed       programs
     • Clear instructions                     • Brief/simple                        records                           medical therapy/       • 90-day refills
     • Use of tools that promote                messages                          • Use technology to identify        medications              instead of 30-day
       adherence                              • Assess adherence                    high risk patients not          • Greater transparency     refills
     • Family/peer support                      often                               receiving appropriate therapy     regarding access to    • Packaging that
     • Lower medication barriers              • Maintain contact                  • Collaborative team-based          medications, costs       promotes
     • Appointment reminders                  • Shared decision                     approaches                        and formulary            adherence
     • Bring medications to visits              making, other                     • Standard treatment plans          preferences            • Medication
     • Education, support, case                 strategies                          and pathways                    • Increase access to       synchronization
       management, telehealth                 • Discuss lifestyle often           • Peer-to-peer feedback             care                     programs
     • Empowerment                            • Prescriptions for both            • Registries to improve care      • Promote and
     • Clinician-Patient shared                 diet and medications              • Academic detailing                reimburse team-
       accountability for                     • Teach other clinicians            • Use audit and feedback with       based collaborative
       performance                            • Use apps                            stakeholders                      care

http://jaccjacc.acc.org/Clinical_Document/Cholesterol_GL_Web_Supplement.pdf
Grundy SM, et al. J Am Col Cardiol 2018. doi: https://doi.org/10.1016/j.jacc.2018.11.003.

                                                            KEY TAKEAWAYS
         1) KEY TAKEAWAY #1
            Use statin therapy with intensity based on level of ASCVD
            risk

         2) KEY TAKEAWAY #2
            Evaluate LDL-C lowering response after implementing
            therapy to determine if goal % lowering is achieved and if at
            or above threshold value to intensify therapy or add a
            nonstatin

         3) KEY TAKEAWAY #3
            Statin therapy is overall very safe

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                    Polling Question
According to the 2018 ACC-AHA Cholesterol guideline,
moderate intensity statin therapy is highly recommended as
in which patient?

1. 30-year-old primary prevention patient with type 1 diabetes
2. 50-year-old primary prevention patient, no diabetes; 10-yr ASCVD
   risk 3.5%
3. 60-year-old primary prevention patient, no diabetes; 10-yr ASCVD
   risk 15%
4. 70-year-old secondary prevention patient

                    Polling Question
A 65-year-old patient with ASCVD is started on rosuvastatin
40 mg po daily. They are adherent with this medication and
4 weeks later LDL-C is 80 mg/dL. Which is recommended
for this patient according to the 2018 ACC-AHA Cholesterol
Guideline?

1.   Continue current therapy; re-check LDL-C in 12 months
2.   Increase rosuvastatin to 80 mg po daily
3.   Add ezetimibe
4.   Add alirocumab

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                   Polling Question
Which is a recommended implementation for patients with
hypercholesterolemia?

1.   Use shared decision making
2.   30-day prescription refills
3.   Assess adherence every other year
4.   Use of PCSK9 inhibitors ahead of statin therapy

                   Polling Question
Which regimen is most appropriate for a 40-year-old
primary prevention patient with a baseline LDL-C of 250
mg/dL who is not on lipid-lowering therapy?

1.   Atorvastatin 20 mg daily
2.   Pravastatin 20 mg daily
3.   Rosuvastatin 20 mg daily
4.   Simvastatin 20 mg daily

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