Hot off the Press: New ACC-AHA Cholesterol Guidelines - Alaska Pharmacists ...
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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
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.
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.
31/12/2019
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
41/12/2019
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.
51/12/2019
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.
61/12/2019
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)
History of multiple ASCVD events LDL-C LDL-C 70-189 mg/dL LDL-C
or ≥190 mg/dL1/12/2019
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.
81/12/2019
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/dL1/12/2019
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.
131/12/2019
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 index1/12/2019
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 index1/12/2019
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.
161/12/2019
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.
171/12/2019
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.
181/12/2019
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.
191/12/2019
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.
201/12/2019
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.
211/12/2019
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
221/12/2019
Case 1 continued…
Case 1 continued…
How would you treat this
patient’s hypercholesterolemia?
231/12/2019
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 discussion1/12/2019
Statin Intensity
High Intensity Moderate Intensity Low Intensity
LDL-C*
≥50% 30 to 49%1/12/2019
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.
261/12/2019
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
271/12/2019
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
281/12/2019
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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