2013 ACC/AHA Guideline on the
Treatment of Blood Cholesterol to
Reduce Athersclerotic Risk
Lynne T Braun, PhD, CNP, FAHA, FAAN
Professor of Nursing, Nurse Practitioner
Rush University Medical Center
2
3
4
Whats New in the Guideline?
Focus on ASCVD risk reduction: 4 statin benefit
groups
Goal is to reduce ASCVD events in secondary and primary
prevention
High-intensity and moderate-intensity statin use
A new perspective on LDL-C and/or non-HDL-C
treatment goals
No evidence to support LDL-C and/or non-HDL-C
treatment targets
Appropriate intensity of statin therapy should be used to
reduce ASCVD risk in those most likely to benefit
5
Stone NJ et al., Circulation 2013.
Whats New in the Guideline?
Global risk assessment for primary prevention
Use of the new Pooled Cohort Equations to estimate 10-
year ASCVD risk in both black and white men and women
http://tools.cardiosource.org/ASCVD-Risk-Estimator/
Safety recommendations
Used RCTs to identify important safety considerations of
statins and provides expert guidance on management of
adverse effects
Role of biomarkers and noninvasive tests
Treatment decisions in selected individuals who are not in
the 4 statin benefit groups may be informed by other
factors
6
Lifestyle as the Foundation for Risk Reduction
Guideline on Lifestyle Management
A critical component of health promotion and
ASCVD risk reduction
Heart-healthy diet
Regular exercise
Avoidance of tobacco products
Maintenance of a healthy weight
7
Eckel RH et al., Circulation 2013.
4 Statin Benefit Groups
1. Individuals with clinical ASCVD, defined as the
inclusion criteria for secondary prevention
statin RCTs
Acute coronary syndromes
History of MI
Stable or unstable angina
Coronary or other arterial revascularization
Stroke or TIA
PAD
8
4 Statin Benefit Groups
2. Individuals with primary elevations of LDL-C
190 mg/dL
3. Individuals with diabetes aged 40-75 years
with LDL-C 70-189 mg/dL and without clinical
ASCVD
4. Individuals without ASCVD or diabetes with
LDL-C 70-189 mg/dL and estimated 10-year
ASCVD risk 7.5% (estimated using the
Pooled Cohort Equations)
9
Use of Statins
Statins have an acceptable margin of safety
when used in properly selected individuals
and appropriately monitored.
Statin therapy recommended for secondary
and primary prevention of ASCVD
Based on RCTs, statins reduce morbidity and
mortality associated with ASCVD
Cost-effective: many statins are now generic
11
Stone NJ et al., Circulation 2013.
Treat to Target was Abandoned
Current trial data does not indicate what the
target should be.
No data from clinical trials on the magnitude of
additional ASCVD risk reduction achieved with one
target lower than another
Potential for adverse effects of multidrug therapy
that might be needed to achieve a specific goal
12
More on LDL-C and Non-HDL-C Goals
RCT evidence shows that ASCVD events are reduced
by using the maximum tolerated statin intensity in
those groups shown to benefit.
In secondary prevention, evidence supports high-
intensity statin therapy to maximally lower LDL-C.
No RCTs titrated drug therapy to specific LDL-C and
non-HDL-C goals to improve ASCVD outcomes.
In AIM-HIGH, the additional reduction in non-HDL-C
with niacin DID NOT further reduce ASCVD risk in
individuals treated to LDL-C levels of 40-80 mg/dL.
13
Primary Prevention
Use the new Pooled Cohort Equations to estimate
10-year ASCVD risk.
Guideline is patient centered
Potential for risk reduction benefit, adverse effects, and
drug-drug interactions, along with patient preferences,
must be considered before statins are prescribed for the
primary prevention of ASCVD.
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Shared Decision Making (SDM)
When Appropriate
Engage in a clinicianpatient discussion before
initiating statin therapy, especially for primary
prevention in patients with lower ASCVD risk.
The cholesterol guidelines recommend not only the
risk calculation, but also the clinicianpatient review
of the risk and the decision to take a statin.
Shared Decision Making (SDM) When
Appropriate
Age is a major contributor to the ASCVD risk calculation.
A 65-year-old man and a 71-year-old woman with optimal risk
factors have a >7.5% 10-year risk.
Clinical judgment, statin safety issues, and consideration of
patient preferences inform the treatment plan.
Prescription of a statin is not automatic.
Treatment plan is a comprehensive approach to risk reduction
that begins with the use of the ASCVD risk calculator and
incorporates addressing of the modifiable risk factors.
10-year ASCVD risk of 7.5% or higher
These individuals can be identified by using the new
Pooled Cohort Equations for ASCVD risk prediction,
developed by the Risk Assessment Work Group.
Stroke now included in ASCVD risk assessment, in
addition to myocardial infarction (MI)
Separate equations for nonwhite populations
Role of Biomarkers and Noninvasive Tests
In select individuals who are not in 1 of 4 statin benefit
groups, and for whom the decision to initiate statin therapy is
unclear, additional factors may be used to inform treatment
decisions.
Factors include:
LDL-C 160 mg/dL
Family history of premature ASCVD
Hs-CRP 2 mg/L
CAC score 300 Agatston units or 75
th
percentile for age,
sex, and ethnicity
ABI < 0.9
Elevated lifetime risk of ASCVD
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Intensity of Statin Therapy
High-intensity statin therapy is defined as a daily
dose that lowers LDL-C by 50%
Moderate-intensity statin therapy lowers LDL-C by
30% to <50%.
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Heading
Stone NJ et al., Circulation 2013.
21
Stone NJ et al., Circulation 2013.
22
Stone NJ et al., Circulation 2013.
Statin Safety Recommendations
Use moderate-intensity statin therapy in patients who are
predisposed to statin-associated adverse effects.
Multiple or serious comorbidities, including impaired renal or
hepatic function
History of previous statin intolerance or muscle disorders
Unexplained ALT elevations > 3 times ULN
Concomitant use of drugs affecting statin metabolism
> 75 years of age
History of hemorrhagic stroke
Asian ancestry
CK should not be routinely measured, although it is reasonable to
measure baseline CK in persons at increased risk for adverse muscle
events
Statin Safety Recommendations
During statin therapy, it is reasonable to measure CK for
muscle symptoms (pain, stiffness, cramping, weakness)
Baseline ALT should be performed before initiating statin
therapy
During statin therapy, it is reasonable to measure ALT if
symptoms suggest hepatotoxicity (unusual fatigue,
weakness, loss of appetite, abdominal pain, dark urine,
jaundice)
Decreasing the statin dose may be considered with 2
consecutive LDL-C levels < 40 mg/dL
It may be harmful to initiate simvastatin at 80 mg daily or
increase the dose to 80 mg daily
Statin Safety Recommendations
Individuals on statin therapy should be evaluated for new
onset DM .
Those who develop DM should be counseled on a heart-healthy
diet, physical activity, healthy body weight, stopping tobacco use.
Statin therapy should be continued to reduce their risk of ASCVD
events.
Use caution in individuals > 75 years of age, persons taking
concomitant meds that alter drug metabolism, taking
multiple drugs, taking drugs for conditions that required
complex medication regimens (transplant patients or
patients with HIV). Review prescribing information before
initiating any cholesterol-lowering drug.
Monitoring Statin Therapy
A baseline lipid panel should be obtained
followed by a second lipid panel 4 to 12
weeks after initiation of statin therapy to
determine patients adherence.
Thereafter, assessments should be every 3
to 12 months as clinically indicated.
LDL-C levels and per cent reduction are to
be used only to assess response to therapy
and adherence.
Insufficient Response to Statin Therapy
In persons with a less-than-anticipated response to statin therapy or are
intolerant to the recommended intensity of statin therapy:
Reinforce adherence to medication and lifestyle changes
Exclude secondary causes of hyperlipidemia
Investigate statin intolerance
In persons at high ASCVD risk receiving the maximum tolerated statin who
have a less-than-anticipated therapeutic response, addition of a nonstatin
LDL lowering agent may be considered if the benefits outweigh the
potential for adverse effects
Individuals with clinical ASCVD < 75 years of age
Individuals with baseline LDL-C 190 mg/dL
Individuals 40 to 75 years of age with diabetes
Synopsis of the Guideline
1. Adherence to a healthy lifestyle
2. Statins therapy for four groups
3. Safe use of statins
4. Shared Decision Making (SDM) when appropriate
5. Estimation of 10-year ASCVD risk
6. Intensity of statin therapy
7. No specific target LDL-C or nonHDL-C goals
8. Regularly monitor patients for adherence
Adapted from Stone NJ Ann Intern Med. Published online 28 Jan 28
2014
Blood Pressure Guidelines
By
JNC 8 Panel
Background
JNC I 1976
JNC 7 2003
JNC 8 Organized in 2008
Review submitted 06/2013
Background
Submitted for review to 16 federal agencies and
20 individual reviewers
NHLBI subsequently decided AHA/ACC should
make future guidelines
Panel members submitted guidelines to JAMA for
review
No official organization sponsorship
Methodology
JNC 7
Followed methods of prior JNC committees
Literature review by expert committee
Evidence from all study designs evaluated
RCT and observational
Comprehensive overview of HTN management
(measurement techniques, resistant hypertension, etc)
Methodology
JNC 8
Based on 2011 Institute of Medicine guidelines
recommendations
1
Systematic review of RCTs only
No meta-analyses of RCTs or observational data
Focused on 3 highest ranked questions for BP
management
Nine recommendations
1
Graham R et al. National Academies 2011
Guideline Questions
1) Does initiating antihypertensive treatment at specific
BP thresholds improve health outcomes?
2) Does treatment with antihypertensive therapy to a
specific BP goal improved health outcomes?
3) Are there differences in benefit/harm between
antihypertensive drugs or drug classes on specific
health outcomes?
Level of Evidence
Strength of Recommendation
James, PA et al. JAMA 2014
Quality of Evidence
James, PA et al. JAMA 2014
James, PA et al. JAMA 2014
James, PA et al. JAMA 2014
JNC 8 Algorithm
James, PA et al. JAMA 2014
James, PA et al. JAMA 2014
JNC 8 Algorithm
James, PA et al. JAMA 2014
JNC 8 Algorithm
Recommendations at a Glance
Jin, J. JAMA 2014
The Minority View
5/17 panel members strongly disagreed with
the age specific recommendation
1) Increased target -> reduction in antihypertensive intensity
on a population level
2) Higher SBP goal may reverse current decline in CVD
mortality, especially stroke
3) Insufficient evidence to support change
Wright et al. Annals of Internal Medicine 2014
The Minority View
Age 60 vs. 80 for different SBP treatment goals
Wright et al. Annals of Internal Medicine 2014
The Minority View
Age 60 vs. 80 for different SBP treatment goals
Wright et al. Annals of Internal Medicine 2014
The Minority View
we concluded that the evidence for
increasing a blood pressure target in high-risk
populations should be at least as strong as the
evidence required to decrease the
recommended blood pressure target
Wright et al. Annals of Internal Medicine 2014
A Caveat for the Old Old
A SBP goal of < 150 mmHg for frail persons
aged 80 years is reasonable since they are at
higher risk for treatment-related adverse
effects
Go AS et al.,
Hypertension 2013
Population Level Effect of Small Changes in Blood Pressure
>50% of those with HTN are older than 60 in the US
51% treated to goal (JNC 7)
Median SBP: treated 136mmHg, untreated 152mmHg
Cook NR, et al. Arch. Int. Med. 1995
Prospective Studies Collaboration
61 observational studies
56,000 vascular deaths
12.7 million person year follow-up
Blood Pressure and CVD Outcomes
Blood Pressure and CVD Outcomes
Lewington et al, Lancet
2002
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Stroke IHD
High Risk in Persons with the Higher Goal
Age substantially increases risk for CV events.
No justification for different targets for patients older and
younger than 60 years
Risk range for white and AA men aged 60 years is 9% to 30%.
Men aged 70 years with controlled SBP at 140 mmHg, even
without CVD or DM, have a 10-year risk > 20%.
Based on absolute risk, using an age threshold of 60 years
to define eligibility for less aggressive treatment lacks
consistency.
53
Wright et al. Annals of Internal Medicine 2014
Insufficient Evidence for Differential HTN Treatment Benefit for
Persons Older and Younger Than 60 Years
HYVET and SHEP trials show that reducing SBP to 140 mmHg
has substantial benefit without harm in older persons.
Lack of benefit was shown in 2 Japanese trials that were
underpowered (125 strokes and 67 CHD events combined).
Uncertain generalizability to other populations, e.g.,
African Americans
Need stronger justification to recommend less aggressive
target in high-risk populations
54
Wright et al. Annals of Internal Medicine 2014
ACCORD BP
4,733 participants with diabetes type 2
Mean age 62, mean follow-up 5 years
Clinical or subclinical CVD or 2 RF
Primary outcome: nonfatal myocardial infarction,
nonfatal stroke, or death from CVD
ACCORD BP
Cushman, WC et al.
NEJM 2010
134mmHg
119mmHg
ACCORD BP
Cushman, WC
et al. NEJM
2010
134mmHg
119mmHg
ACCORD BP
Cushman, WC et al. NEJM
2010
Go AS et al., Hypertension 2013.
Decreasing your sodium intake: where
is salt found in our diets?
Treatment Recommendations: JNC 8
In the general nonblack population, including
those with DM, initial treatment should include a
thiazide-type diuretic, CCB, ACEI, or ARB.
In the general black population, including those
with DM, initial treatment should include a
thiazide-type diuretic or CCB.
In pts 18 years with CKD and HTN, initial or
add-on treatment should include ACEI or ARB to
improve kidney outcomes.
Treatment Recommendations: JNC 8
If goal BP is not reached within a month of
treatment, increase the dose of the initial drug or
add a second drug. The clinician should continue
to assess BP and adjust the treatment regimen until
goal BP is reached. If goal BP cannot be reached
with 2 drugs, add a third drug.
Do not use an ACEI and ARB in the same patient.
Consider referral to a hypertension specialist for
patients with difficult to control blood pressure.
Case Example
52-year-old Caucasian male
History of hypertension; nonsmoker
No known history of CAD; no symptoms of CAD
Father had MI at age 55; mother has HTN
BMI 29.5 kg/m
2
BP 160/88 mmHg (treated with lisinopril 10 mg)
TC 210, HDL 33, TG 180, LDL 141, glucose 80
Pooled Cohort Risk Calculator
Determines estimated 10-year risk for ASCVD
events
http://tools.cardiosource.org/ASCVD-Risk-
Estimator/
10-year ASCVD risk: 11.5% vs 2.6% for male
patient, same age, with optimal risk factors
Lifetime ASCVD risk: 69% vs 5% for male
with optimal risk factors
How would you manage this patient?
Primary Prevention with a 10-year ASCVD
risk 7.5%
Goals
Moderate-to-high intensity statin
Weight reduction; heart-healthy diet
Blood pressure control (< 140/90 mmHg)
-drug choices?
-monitor in the office and at home
Regular physical activity program
What if this patients 10-year
ASCVD risk was 7%?
