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Statin treatment for lipids is generally recommended for those with known
ASCVD or diabetes mellitus type 2 as secondary prevention. Similarly, statin therapy is generally recommended for primary prevention in patients with no known
ASCVD but a calculated high risk. Guidelines developed by the ACC/AHA in
2013 and updated in 2018, the USPSTF in 2016, and NICE in 2014 vary in their
recommendations for primary prevention initiation and intensity of treatment with
statins. Like many areas of medicine, the current guidelines for treatment of cholesterol are actively changing, and providers, in collaboration with their patients, have
the opportunity to decide which recommendations to use.
The recommended intensity of the statin medication should be proportionate
to the risk of CHD: the higher one’s risk, the higher intensity the statin therapy
should be. It also is important to note that for patients who do not tolerate highintensity statins, using a lower intensity statin would still provide some cardiovascular benefit if the lower intensity statin can be tolerated. Assessment scores
can overestimate or underestimate risk in certain groups, so use of the appropriate
assessment tool for the patient is important. There are insufficient data to support
one assessment tool over another for predicting cardiovascular risk. Comparison of
ACC/AHA, USPSTF, and NICE guidelines is provided in Table 35–1.
ACC/AHA Guidelines. The ACC/AHA guidelines recommend statin therapy
for all persons age 20 and up in the following four additional groups:
Patients ≤ 75 years old with clinical CVD
Patients with LDL-C ≥ 190 mg/dL
Patients age 40 to 75 years with diabetes and LDL-C ≥ 70 mg/dL
Patients age 40 to 75 years with 10-year CVD risk ≥ 7.5% and LDL-C ≥ 70 mg/dL
The risk assessment is based on the pooled cohort equations, which can be
accessed online (http://static.heart.org/riskcalc/app/index.html#!/baseline-risk).
The USPSTF also recommends using the pooled cohort equations for risk
calculation.
NICE Guidelines. The NICE recommendations for the primary prevention of
CVD use the QRISK®2 risk assessment tool, which includes renal disease in its
calculation (https://www.qrisk.org). Statin therapy for adults should begin with a
≥ 10% ten-year risk. Statin therapy should begin with a focus on high intensity and
low cost. NICE recommends offering atorvastatin 20 mg for primary prevention if
10-year risk ≥ 10% and to people age 85 years or older. If a statin is contraindicated
or not tolerated, ezetimibe can be offered. For patients with known CHD, treatment should be started with atorvastatin 80 mg. NICE recommends against use of
fibrates, nicotinic acid, anion exchange resins, or omega-3 fatty acids for primary or
secondary prevention.
American Academy of Family Physicians Guidelines. The American Academy of
Family Physicians (AAFP) released its clinical practice guideline with endorsement
of the AHA/ACC recommendations, with qualifications, in June 2014. The key
recommendations are listed in Table 35–2. The qualifications listed by the AAFP
were that the CVD risk assessment tool has not been validated and may overestimate risk, and a cutoff of 7.5%, rather than 10%, will significantly increase the
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Table 35–1 • ACC/AHA, NICE, AND USPSTF GUIDELINES FOR
TREATING CHOLESTEROL
ACC/AHA Guidelines
Statin Therapy
Risk Category
Clinical atherosclerotic
cardiovascular disease
LDL-C ≥ 190 mg/dL Age ≥ 20 years Not applicable
Diabetes plus LDL-C
70-189 mg/dL
Age 40-75 years plus
LDL-C 70-189 mg/dL
Age 20-39 years plus
LDL-C ≥ 160 mg/dL
Age 0-19 with lifestyle
management
Recommended If
Age 20-75 years Age > 75 years
Age 40-75 years Age 21-40 years or > 75 years
Estimated 10-year risk of atherosclerotic cardiovascular disease ≥ 7.5%
Not applicable Early ASCVD in family history
Familial severe hypercholesterolemia
and premature ASCVD in family
NICE Guidelines
Risk Category Drug Recommendations
Existing cardiovascular disease
(secondary prevention)
10-year cardiovascular disease risk > 10% Atorvastatin 20 mg/d
10-year cardiovascular disease risk < 10% Optimize all other modifiable cardiovascular
Atorvastatin 80 mg/d for all adults with
cardiovascular disease
Do not delay statin treatment in patients with
acute coronary syndrome
risk factors
Statin not recommended
USPSTF Guidelines for Primary Prevention
Statin Therapy
Risk Category
LDL > 190 mg/dL No recommendation
Age 40-75 Estimated 10-year risk of
Age 40-75 years Estimated 10-year risk of
Age > 75 years No recommendation Insufficient evidence to
Recommended If Statin Therapy
atherosclerotic cardiovascular
disease < 10% and 1 or more
risk factors
atherosclerotic cardiovascular
disease ≥ 10% and 1 or more
risk factors
Reasonable to Consider
Statin Therapy If
Estimated 10-year risk of
atherosclerotic cardiovascular
disease 5% to < 7.5%
Age 10, a LDL-C ≥ 190 or
≥ 160 with strong early
family history
Consider low- to moderateintensity statin
Initiate low- to moderateintensity statin
recommend
Data from Dynamed, NICE, USPSTF, and ACC/AHA guidelines.
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Table 35–2 • AAFP CLINICAL PRACTICE GUIDELINES KEY
RECOMMENDATIONS FOR CHOLESTEROL MANAGEMENT
Individuals with LDL-C ≥ 190 mg/dL or triglycerides ≥ 500 mg/dL should be evaluated for
secondary causes of hyperlipidemia.
Adults ≥ 21 years of age with a primary LDL-C ≥ 190 mg/dL should be treated with high-intensity
statin therapy unless contraindicated.
Adults 40-75 years of age with an LDL-C 70-189 mg/dL without clinical ASCVD or diabetes and
an estimated 10-year ASCVD risk ≥ 7.5% should be treated with moderate- to high-intensity
statin therapy.
Adults 40-75 years of age with diabetes mellitus and an LDL-C 70-189 mg/dL should be treated
with moderate-intensity statin therapy.
Individuals ≤ 75 years of age who have clinical ASCVD should be treated with high-intensity statin
therapy unless contraindicated.
There is not enough evidence to recommend for or against treating blood cholesterol to
target levels.
There is not enough evidence to recommend the use of nonstatin medication combined with
statin therapy to further reduce ASCVD events.
Adapted from AAFP Clinical Practice Guideline on Cholesterol.
number of patients on statins. Also, many of the recommendations were based on
expert opinion, although some points were evidence based, and 7 out of 15 members of the guideline panel had conflicts of interest. Nevertheless, it is indisputable
that statin agents decrease mortality in patients with elevated LDL-C.
Other Forms of Treatment
Therapeutic lifestyle changes are the cornerstone of all treatments for hyperlipidemia.
All patients should be educated on healthier living, including dietary modifications,
increased physical activity, and smoking cessation. Weight reduction should be
encouraged.
Specific dietary recommendations include limiting trans-fatty acid intake to
< 1% of total calories, limiting saturated fats to < 7% of total calories, replacing
saturated fats with polyunsaturated fats, and having a total intake of < 200 mg/d of
cholesterol. Total dietary fat should be kept to no more than 35% of total calories,
with < 10% polyunsaturated fat. AHA diet and lifestyle modifications include
Balancing calorie intake and physical activity to achieve or maintain healthy
body weight
Consuming a diet rich in vegetables and fruits
Choosing whole-grain, high-fiber foods
Consuming fish, especially oily fish, at least twice a week
Minimizing added sugars and sugary beverages
Choosing low-salt foods
Consuming alcohol in moderation
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The addition of dietary soluble fiber and plant stanols/sterols can be beneficial
as well. Soluble fiber (10 to 25 g) and plant stanols/sterols (2 g) can be added to
reduce CVD and CHD risk. Referral to a dietician may be helpful as well. When
TLC is instituted, regular follow-up must be arranged.
Therapeutic lifestyle changes should continue to be reinforced and encouraged
even when starting medications. Ezetimibe is recommended as the second ther-
apy for patients who cannot tolerate any level statin or have contraindications.
A list of medications available for treatment of hyperlipidemia is included in
Table 35–3.
Cholesterol treatment is an example of how recommendations can create controversy in the management of chronic disease. The recommendations for evaluation, treatment, and ongoing management of high cholesterol have changed
Table 35–3 • MEDICATIONS USED TO LOWER CHOLESTEROL
Drug Class/
Medication Effects Side Effects Contraindications
Statin
• Lovastatin
• Pravastatin
• Fluvastatin
• Atorvastatin
• Rosuvastatin
• Simvastatin
Bile acid sequestrants
• Cholestyramine
• Colestipol
• Colesevelam
Nicotinic acids
• Immediate-release,
sustained-release,
or extended-release
nicotinic acid
Fibric acids
• Gemfibrozil
• Fenofibrate
Cholesterol absorption
blocker
• Ezetimibe
Monoclonal antibody,
PCSK9 inhibitors
• Evolocumab
• Alirocumab
LDL ↓18% to
55%; HDL ↑5% to
15%; triglytrides
(TG) ↓7% to 30%
LDL ↓15% to
30%; HDL ↑3%
to 5%; TG no
change; or
increase
LDL ↓5% to 25%;
HDL ↑15% to
35%; TG ↓20% to
50%
LDL ↓5% to 20%;
HDL ↑10% to
20%; TG ↓20% to
50%
LDL ↓13% to
25%; HDL ↑3%
to 5%; TG ↓5% to
14%
LDL ↓50%
82.3% LDL < 70
Myopathy, myalgia,
increased liver enzymes
Gastrointestinal
distress, constipation,
decreased absorption of
other medications
Flushing, hyperglycemia,
hyperuricemia, upper GI
distress, hepatotoxicity
Dyspepsia, gallstones,
myopathy, unexplained
non-CHD deaths in a
World Health Organization study
Abdominal pain,
diarrhea
Nasopharyngitis,
upper respiratory tract
infection, influenza,
back pain
Active or chronic liver
disease; relative
contraindication with
cytochrome P-450
inhibitors, cyclosporine,
Dysbetalipoproteinemia; TG > 400
Absolute: chronic liver
disease, severe gout
Relative: diabetes,
hyperuricemia, peptic
ulcer disease
Severe renal disease,
severe hepatic disease
Hepatic insufficiency/
active liver disease
Cost prohibitive
Abbreviation: PCSK9: Proprotein convertase subtilisin/kexin type 9.
Data from ATP III report, ezetimibe product information, and Sullivan et al.
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significantly over recent years, with a focus on risk assessment. New development
of treatments will also lend to ongoing changes in the future.
CASE CORRELATION
See also Case 20 (Chest Pain) and Case 33 (Obesity).
COMPREHENSION QUESTIONS
35.1 A 62-year-old man is being seen in the office for establishment of care. He
reports that he had an acute myocardial infarction (MI) 1 year previously
and lost his insurance and has not been able to take any medications since his
heart attack. He smokes half a pack a day, which is less than the 1 pack per
day previously. On examination, his blood pressure is 110/60 mm Hg. The
cardiac examination is normal, and there is no jugular vein distension or pedal
edema. His LDL-C is 105 mg/dL, HDL cholesterol is 28 mg/dL, and total
cholesterol is 170 mg/dL. According to the NICE guidelines, what medication therapy should be initiated at this time?
A. Ezetimibe
B. Atorvastatin
C. Niacin
D. Gemfibrozil
35.2 A 55-year-old woman presents to your office for follow-up. She was discharged from the hospital 1 week ago following an acute MI. She has quit
smoking since that time and vows to stay off cigarettes forever. Her lipid levels are total cholesterol 240 mg/dL, HDL 50 mg/dL, LDL-C 160 mg/dL, and
triglycerides 150 mg/dL. In addition to initiation of TLCs, which of the
following is the most appropriate management at this time?
A. Nothing further
B. Start on a statin
C. Start on nicotinic acid
D. Start on a statin and nicotinic acid
35.3 A 48-year-old man is being seen for follow-up from an elevated cholesterol
level at a health screening, which is recorded as 250 mg/dL. He denies significant medical history and has no symptoms. Which of the following tests
is the most important further evaluation of this patient’s condition?
A. Electrocardiogram (ECG)
B. Stress test
C. Complete blood count (CBC)
D. Thyroid-stimulating hormone level
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ANSWERS
35.1 B. This patient has known CHD (prior acute MI) and should be started on
statin therapy. A high-intensity statin dose should be initiated for secondary prevention of CVD. Other lipid agents (answer A, ezetimibe; answer C,
niacin; and answer D, gemfibrozil) do not have as much efficacy in lowering
mortality. Other agents that reduce mortality after an acute MI include baby
aspirin and beta-blocking agents.
35.2 B. This patient has known CHD, documented by her recent MI. All guidelines recommend therapeutic life changes as an integral part of care. With
known CHD, statin therapy is also indicated and has been shown to decrease
mortality. Therefore, neither lifestyle changes alone (answer A) nor nicotinic
therapy alone (answer C) are the best choice for this patient. ACC/AHA
guidelines would recommend high-intensity statin therapy. Also, combined
therapy with a statin agent and nicotinic agent (answer D) is not indicated
unless the lipid levels are not controlled with maximal monotherapy.
35.3 D. Hypothyroidism is a potential cause of secondary dyslipidemia. A TSH
level is a reasonable test to perform in this setting in a patient with an elevated
cholesterol level. There is no indication to screen for CHD with an ECG
(answer A) or stress test (answer B) in this asymptomatic person, who has no
findings of CHD, stroke, or peripheral arterial disease. Other tests to perform
could include fasting blood glucose, liver enzymes, and a measurement of
renal function. A CBC (answer C) is often used as a screening test but would
not be used to further diagnose hyperlipidemia.
CLINICAL PEARLS
» Lipid levels must always be interpreted in the context of the individual’s
overall risk factors for CHD.
» Statins have the best data to support improvement in outcomes that
are clinically significant, such as heart attacks, strokes, and death. Unless
there is a contraindication, a statin should be the first medication used
for cholesterol reduction.
» Pharmacotherapy may be considered in patients with ASCVD risk above
7.5% according to ACC/AHA guidelines and 10% according to NICE and
USPSTF guidelines.
» Remind patients who are taking lipid-lowering medications that lifestyle
modifications are still necessary. Medications are not a substitute for a
healthy lifestyle.
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REFERENCES
2016 ACC expert consensus decision pathway on the role of non-statin therapies for LDL-cholesterol
lowering in the management of atherosclerotic cardiovascular disease risk. J Am Coll Cardiol.
2016;68(1):92-125.
2017 focused update of the 2016 ACC expert consensus decision pathway on the role of non-statin
therapies for LDL-cholesterol lowering in the management of atherosclerotic cardiovascular disease
risk. J Am Coll Cardiol. 2017;70(14):1785-1822.
Grundy SM, Stone NJ, Bailey AL, Beam C, et al. 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/
ADA/AGS/APhA/ASPC/NLA/PCNA guideline on the management of blood cholesterol: executive summary. J Am Coll Cardiol. 2019;73(24). doi:10.1016/j.jacc.2018.11.002
Last AR, Ference JD, Menzel ER. Hyperlipidemia: drugs for cardiovascular risk reduction in adults.
Am Fam Physician. 2017;95(2):78-87.
National Cholesterol Education Program. The third report of the NCEP Expert Panel on the detection,
evaluation and treatment of high blood cholesterol in adults. Item no: 02-5215; 2002.
National Institute for Health and Care Excellence (NICE). Lipid modification: cardiovascular risk
assessment and the modification of blood lipids for the primary and secondary prevention of cardiovascular disease. BMJ. 2014;349:g4356.
Nayor M, Ramachandran VS. Recent update to the US cholesterol treatment guidelines: a comparison
with international guidelines. Circulation. 2016;133:1795-1806.
Rader DJ, Kathiresan S. Disorders of lipoprotein metabolism. In: Kasper D, Fauci A, Hauser S, Longo
D, Jameson J, Loscalzo J, eds. Harrison’s Principles of Internal Medicine. 20th ed. New York, NY:
McGraw Hill; 2018.
Sullivan D, Olsson AG, Scott R, Xue A, Gebski V, Wasserman SM, Stein EA. Effect of a monoclonal
antibody to PCSK9 on low-density lipoprotein cholesterol levels in statin-intolerant patients: the
GAUSS randomized trial. JAMA. 2012;308(23):2497-2506. doi:10.1001/jama.2012.25790
US Preventive Services Task Force. Statin use for the primary prevention of cardiovascular disease
in adults: US Preventive Services Task Force recommendation statement. JAMA. 2016;316(19):
1997-2007. doi:10.1001/jama.2016.15450
CASE 36
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A 20-month-old girl who is new to your practice is brought in by her mother
because the child has been crying and not walking for the past day. Her mother
reports that the child is “very clumsy and falls a lot.” She says that the little girl
may have injured her leg by falling off the sofa because, she repeats, “She really
is clumsy and falls a lot.” Upon review with the mother, she states that the child
has no significant medical history and takes no medications regularly. There are
two older children in the family, ages 4 and 6 years, who are in good health but
also are “clumsy and forever hurting themselves.” The husband lives in the home.
Without any questioning or prompting, the mother states that her husband is “a
good man but he’s under a lot of stress.” You ask the mother to undress the child
for an examination, and she quickly replies, “Do you really have to undress her?
She’s very shy.” You politely, but firmly, say that you need to examine her, and she
removes the child’s pants. You see that her right knee is visibly swollen and tender
to palpation on the medial bony prominences. You also note numerous bruises of
the buttocks and posterior thighs, which appear to be of different ages. There are
also several small, circular scars on the legs, each about a centimeter in size. “See
how clumsy she is?” the mother says, pointing to her bruises. An x-ray of the child’s
knee shows a corner fracture of the distal femoral metaphysis.
▶ What is the likely mechanism of this child’s injuries?
▶ What further evaluation is necessary at this time?
▶ What legal obligation must a health care provider fulfill in this circumstance?
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ANSWERS TO CASE 36:
Family Violence
Summary: A 20-month-old girl presents with
Crying and not walking
Multiple bruises at different stages of healing and circular wounds that are suspicious
for cigarette burns
Knee x-ray that shows a metaphyseal corner fracture, an injury that is inconsistent
with the stated history of “falling off the sofa”
Reports from her mother that the child is “clumsy and falls a lot”
Most likely mechanism of injuries: Inflicted injuries, including leg injury from forceful pulling, bruising from hitting the child’s legs, and cigarette burns.
Further evaluation at this time: Complete, unclothed physical examination of the
child (including ophthalmoscopic and neurologic examinations); radiographic
skeletal survey.
Legal obligation: Report suspected child abuse to the appropriate child protective
services organization.
ANALYSIS
Objectives
1. Be able to state the symptoms and signs suggestive of child maltreatment and
abuse. (EPA 1, 2)
2. Be able to state the situations in which the risk of family violence increases.
(EPA 12)
3. Be able to state the medicolegal requirements involved in situations of family
violence. (EPA 5, 9, 12)
Considerations
Family violence can occur in families of any socioeconomic class and in households
of any composition. The term family violence includes child abuse, intimate partner
violence (IPV), and elder abuse. The abuse that occurs can be physical, sexual, emotional, psychological, or economic. It can take the forms of battering, raping, threatening, intimidating, isolating from friends and family, stealing, and preventing the
earning of money, among many others.
In the case presented here, there are several signs of intentionally inflicted injuries to the child. The presence of numerous bruises of varying ages, especially on
relatively protected areas such as the buttocks and upper posterior thighs, should
raise suspicion. Finding injuries inconsistent with the reported history also can be
a clue. Certain types of fractures, such as metaphyseal corner fractures (caused by
forceful jerking or twisting of the leg), are usually a result of abuse. The identification of wounds consistent with cigarette burns is highly specific for abuse.
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Clinicians often find dealing with these situations extremely difficult and
uncomfortable. They may feel caught between two partners—both of whom are
patients—who give conflicting stories. They may have concerns about the legal
implications of their findings and fear legal actions if they make reports to authorities. They may have frustrations in dealing with a person who will not leave an
abusive spouse and may feel ill-trained to deal with many of these situations. By
becoming familiar with situations in which family violence is more likely to occur,
knowing the laws regarding disclosure and reporting, and learning to recognize the
signs of family violence, clinicians can be better prepared to address these situations
when they occur.
APPROACH TO:
Family Violence
DEFINITIONS
CHILD MALTREATMENT: An inclusive term covering physical abuse; sexual
abuse; emotional abuse; parental substance abuse; physical, nutritional, and emotional neglect; supervisional neglect; and Munchausen syndrome by proxy.
ELDER MISTREATMENT: Intentional or neglectful acts by a caregiver or trusted
individual that harm a vulnerable older person.
NEGLECT: Failure to provide the needs required for functioning or for the avoidance of harm.
PHYSICAL ABUSE BATTERY: Intentional physical actions (eg, biting,
kicking, punching) that can cause injury or pain to another person.
CLINICAL APPROACH
Screening
Family violence is a pattern of abusive behavior in any relationship in which one
individual gains or maintains power or control over another individual. This abuse
can take the form of physical violence (battery), sexual violence, intimidation,
emotional and psychological abuse, economic control, neglect, threats, and isolation from others. During screening, evaluation, and intervention related to cases
of domestic and family violence, it is important to consider cultural influences and
the unique dynamics of special populations (eg, lesbian, gay, bisexual, transgender,
older couples, and immigrant populations).
Numerous professional organizations, such as the American Medical Association, the American Academy of Family Physicians, and the American College of
Obstetricians and Gynecologists, advocate for the routine screening of women for
abuse by direct and nonjudgmental questioning. Many tools exist for screening,
from simple questioning to more formal inventory tools. The simple question, “Do
you feel safe in your home?” has a sensitivity of 8.8% and a specificity of 91.2%, so
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