Understanding the New Cholesterol Treatment Guidelines: What Patients Need to Know

Table of Contents

• Key Points
• Background: Why This Research Matters
• Key Features of the New Guidelines
• The Four Groups Who Should Consider Statins
• Understanding Statin Intensity Levels
• Who Should NOT Take Statins
• Key Changes for Clinical Practice
• The Risk Calculator Controversy
• Case Examples: How the Guidelines Work in Practice
• Clinical Implications for Patients
• Study Limitations
• Recommendations for Patients
• Frequently Asked Questions
• Source Information

Key Points

• The 2013 ACC-AHA guidelines shift focus from target cholesterol numbers to 10-year risk of heart attack or stroke.
• Four patient groups benefit from statins, but the risk calculator may overestimate risk and remains unvalidated.
• Statins are categorized as high-intensity (lower LDL by 50%+) or moderate-intensity (lower LDL by 30–49%).
• Healthy adults over 75, dialysis patients, and those with symptomatic heart failure should not take statins.
• Routine LDL monitoring is no longer recommended; instead, focus on risk calculation and side-effect monitoring.

Background: Why This Research Matters

For more than a decade, doctors relied on the National Cholesterol Education Program's Adult Treatment Panel III report, released in 2002, to guide their decisions about treating high cholesterol. Those older guidelines were widely accepted and applied consistently across the United States.

On November 12, 2013, however, the American College of Cardiology–American Heart Association (ACC-AHA) Task Force on Practice Guidelines released a major update that dramatically changed how doctors approach cholesterol treatment. Unlike the previous recommendations, which focused on reaching specific cholesterol levels, the new guidelines emphasize identifying patients whose risk of heart disease and stroke clearly outweighs the potential harms of treatment.

These changes have generated considerable debate among medical experts, with some arguing that certain elements of the recommendations are not firmly evidence-based. Nevertheless, the new guidelines are likely to have a major impact on how lipid management (cholesterol treatment) is practiced in clinics and hospitals nationwide.

Key Features of the New Guidelines

The new guidelines represent a substantial departure from past recommendations. Previously, doctors were encouraged to treat patients to specific low-density lipoprotein (LDL) cholesterol targets — often called "bad cholesterol" — with the goal being a particular number on a blood test. The new guidelines instead rely heavily on results from randomized, controlled trials (rigorous scientific studies) that largely used fixed doses of statin medications — drugs known as HMG-CoA reductase inhibitors that block the liver's ability to produce cholesterol.

Under the new approach, the expert panel identified four distinct subgroups of patients for whom the benefits of statins clearly outweigh the risks. The guidelines also specify which intensity of statin therapy should be used in each group, based on how much the medication lowers LDL cholesterol levels.

An important detail about outcomes: the trials underpinning these guidelines measured atherosclerotic cardiovascular disease, which the authors define as nonfatal heart attack, death from coronary heart disease, or nonfatal or fatal stroke.

The Four Groups Who Should Consider Statins

According to the 2013 ACC-AHA guidelines, statin therapy is clearly beneficial for the following four patient groups:

1. Patients with clinically evident atherosclerotic cardiovascular disease — including those who have experienced an acute coronary syndrome, a history of heart attack, stable or unstable angina (chest pain), coronary or other arterial revascularization (such as angioplasty or bypass surgery), stroke, transient ischemic attack (a "mini-stroke"), or peripheral arterial disease presumed to be caused by atherosclerosis (hardening of the arteries).
2. Patients with primary LDL cholesterol levels of at least 190 mg per deciliter (mg/dl) — a very high level of "bad cholesterol."
3. Patients with type 1 or type 2 diabetes, age 40 to 75 years, with LDL cholesterol levels of 70 to 189 mg/dl.
4. Patients with a calculated 10-year risk of atherosclerotic cardiovascular disease of at least 7.5% (according to the new pooled cohort equations) and an LDL cholesterol level of at least 70 mg/dl.

For most patients in these groups, high-intensity statin therapy is generally recommended. Patients who cannot tolerate high-intensity treatment, or those with diabetes who have a 10-year risk below 7.5%, should receive moderate-intensity statin therapy instead.

Understanding Statin Intensity Levels

The guidelines divide statin therapy into two main intensity categories based on how much they lower LDL cholesterol on average.

High-intensity statin therapy lowers LDL cholesterol by approximately 50% or more on average. The recommended options are:

• Atorvastatin (brand name Lipitor), 40 to 80 mg daily
• Rosuvastatin (brand name Crestor), 20 to 40 mg daily

Moderate-intensity statin therapy lowers LDL cholesterol by approximately 30% to less than 50% on average. The recommended options are:

• Atorvastatin, 10 to 20 mg daily
• Rosuvastatin, 5 to 10 mg daily
• Simvastatin (brand name Zocor), 20 to 40 mg daily
• Pravastatin (brand name Pravachol), 40 to 80 mg daily
• Lovastatin (brand name Mevacor), 40 mg daily
• Extended-release fluvastatin (brand name Lescol XL), 80 mg daily
• Fluvastatin, 40 mg twice a day
• Pitavastatin (brand name Livalo), 2 to 4 mg daily

Patients taking statins should be monitored by their doctors for muscle injury and liver injury, as well as for the development of new-onset diabetes, which is a recognized potential side effect of statin therapy.

Who Should NOT Take Statins

An important caveat of the new guidelines is that they also identify groups of patients for whom available data do not support statin therapy and for whom no recommendation is made. These groups include:

1. Patients older than 75 years of age, unless they have clinical atherosclerotic cardiovascular disease (established heart or vascular disease).
2. Patients who need hemodialysis (dialysis to filter waste from the blood due to kidney failure).
3. Patients with New York Heart Association (NYHA) class II, III, or IV heart failure — meaning heart failure that causes symptoms even with mild activity or at rest.

Additionally, the expert panel stated that it found no evidence to support the use of non-statin cholesterol-lowering drugs — such as ezetimibe, bile acid sequestrants, or niacin — either in combination with statin therapy or as a replacement in patients who cannot tolerate statins.

There is a special note for patients who are predisposed to adverse statin effects. This includes those with impaired kidney or liver function, other serious coexisting conditions, a history of statin intolerance, use of other medications that affect statin metabolism (such as amiodarone), age over 75 years, or unexplained elevations in alanine aminotransferase (a liver enzyme) more than 3 times the upper limit of normal. For these patients, moderate-intensity statin therapy is recommended when high-intensity therapy would otherwise be indicated.

Key Changes for Clinical Practice

Practicing clinicians will see considerable changes in their day-to-day routines as they adopt these new guidelines. The authors summarize six major shifts:

1. Avoidance of cholesterol-lowering therapy in certain patient groups — specifically, those with heart failure, those on dialysis, and healthy adults over 75.
2. Elimination of routine LDL cholesterol blood tests in patients receiving statin therapy, because specific target levels are no longer emphasized. If the goal is no longer a fixed number, routine monitoring of that number becomes less meaningful.
3. Avoidance of non-statin cholesterol-lowering medications in patients who can tolerate statins.
4. More conservative use of statins in patients older than 75 years of age who do not have established cardiovascular disease.
5. Diminished use of surrogate markers such as C-reactive protein (a marker of inflammation) or coronary calcium scores (imaging-based measurements of plaque in the arteries).
6. Use of a new risk calculator that is certain to identify a larger number of patients for statin treatment than previous approaches.

This last change is particularly significant — the new pooled cohort equations are publicly available, and doctors can use them at the American Heart Association's website (http://my.americanheart.org/cvriskcalculator) or at the CardioSource website devoted to the 2013 prevention guideline tools.

The Risk Calculator Controversy

Not everyone agrees that the new risk calculator is accurate. Researchers Ridker and Cook, whose analysis was published in the journal The Lancet, raised serious concerns about the calculator, which is based on data from several large cohort studies (groups of people followed over time). Their core criticism is that the risk calculator has never been prospectively tested — meaning it has not been validated in a real-world setting where its predictions were compared against actual outcomes.

When Ridker and Cook compared the calculator's predictions with findings from several large cohorts of people without current cardiovascular disease, the new risk calculator appeared to overestimate observed risks. This means that some patients might be told their risk is higher than it truly is, potentially leading to unnecessary statin prescriptions.

The guideline developers, however, pushed back, offering two reasons why the cohorts used by Ridker and Cook may not be appropriate for testing the calculator's accuracy:

• Volunteer bias: The cohorts include volunteers, who are likely to be healthier and more health-conscious than the general population. Healthier people would naturally have lower cardiovascular event rates, making the calculator appear to overestimate risk when it may be accurate for the broader public.
• Modern treatment effects: Patients in these cohorts have received modern therapies for reducing cardiovascular risk — such as blood pressure medications, aspirin, and other preventive treatments — which would alter the natural history of the disease and lower observed event rates compared with what the calculator predicts for untreated populations.

The authors of this NEJM analysis note that there is likely to be considerable interest in prospectively testing the new risk calculator in multiple groups of various ethnic backgrounds to substantiate its relevance as a foundation for the primary prevention (preventing a first event) of atherosclerotic cardiovascular disease.

Case Examples: How the Guidelines Work in Practice

To help doctors understand how to apply the new guidelines, the original article included a table of sample patient cases showing who should receive high-intensity statins, moderate-intensity statins, and who should not receive statins at all. Here are those examples, with the calculated 10-year risk of coronary heart disease (CHD) or stroke for each person.

Cases Where High-Intensity Statin Therapy Is Recommended

• 62-year-old Black man: Total cholesterol 140 mg/dl, HDL (good cholesterol) 35 mg/dl, systolic blood pressure 130 mm Hg, not on blood pressure medication, not diabetic, nonsmoker. Calculated 10-year risk: 9.1%. Comment: Total cholesterol is quite low, but age is over 60 and HDL is also low.
• 42-year-old White male smoker: Total cholesterol 250 mg/dl, HDL 40 mg/dl, systolic blood pressure 130 mm Hg, not on blood pressure medication, not diabetic, smoker. Calculated 10-year risk: 9.0%. Comment: Total cholesterol is high and the patient also smokes.
• 50-year-old White female smoker with diabetes: Total cholesterol 180 mg/dl, HDL 50 mg/dl, systolic blood pressure 135 mm Hg, taking blood pressure medication, diabetic, smoker. Calculated 10-year risk: 9.8%. Comment: Total cholesterol and HDL are within desirable ranges, but the patient has diabetes, hypertension, and smokes.
• 73-year-old Black woman: Total cholesterol 170 mg/dl, HDL 50 mg/dl, systolic blood pressure 110 mm Hg, not on blood pressure medication, not diabetic, nonsmoker. Calculated 10-year risk: 9.5%. Comment: Total cholesterol is low, but age is over 70.

Cases Where Moderate-Intensity Statin Therapy Is Recommended

• 48-year-old White woman with diabetes: Total cholesterol 180 mg/dl, HDL 55 mg/dl, systolic blood pressure 130 mm Hg, not on blood pressure medication, diabetic, nonsmoker. Calculated 10-year risk: 1.8%. Comment: Patient qualifies because she has diabetes but has a 10-year risk below 7.5%.
• 61-year-old White man with a history of statin intolerance: Total cholesterol 200 mg/dl, HDL 35 mg/dl, systolic blood pressure 145 mm Hg, taking blood pressure medication, not diabetic, nonsmoker. Calculated 10-year risk: 17%. Comment: Patient qualifies because his 10-year risk exceeds 7.5%, but he cannot tolerate high-intensity statins due to his history.
• 79-year-old Black man: Total cholesterol 150 mg/dl, HDL 40 mg/dl, systolic blood pressure 120 mm Hg, not on blood pressure medication, not diabetic, nonsmoker. Calculated 10-year risk: 13.7%. Comment: Patient qualifies because his 10-year risk exceeds 7.5%, but he is over 75 years old.
• 54-year-old Black woman taking amiodarone: Total cholesterol 182 mg/dl, HDL 45 mg/dl, systolic blood pressure 135 mm Hg, taking blood pressure medication, not diabetic, smoker, taking amiodarone (a heart rhythm medication). Calculated 10-year risk: 12.1%. Comment: Patient qualifies because her 10-year risk exceeds 7.5%, but she is taking a drug that affects statin metabolism, so moderate-intensity therapy is safer.

Cases Where Statin Therapy Is NOT Recommended

• 57-year-old White man: Total cholesterol 255 mg/dl, HDL 45 mg/dl, systolic blood pressure 110 mm Hg, not on blood pressure medication, not diabetic, nonsmoker. Calculated 10-year risk: 7.2%. Comment: Total cholesterol is high, but the patient has no other risk factors, and his risk falls just below the 7.5% threshold.
• 42-year-old Black male smoker: Total cholesterol 180 mg/dl, HDL 40 mg/dl, systolic blood pressure 130 mm Hg, not on blood pressure medication, not diabetic, smoker. Calculated 10-year risk: 6.3%. Comment: Patient smokes but has no other risk factors.
• 64-year-old Black woman: Total cholesterol 190 mg/dl, HDL 45 mg/dl, systolic blood pressure 125 mm Hg, not on blood pressure medication, not diabetic, nonsmoker. Calculated 10-year risk: 6.9%. Comment: HDL cholesterol is low for a woman (below 50 mg/dl), but the patient has no other risk factors.
• 46-year-old White woman with hyperlipidemia and hypertension: Total cholesterol 230 mg/dl, HDL 55 mg/dl, systolic blood pressure 150 mm Hg, taking blood pressure medication, not diabetic, nonsmoker. Calculated 10-year risk: 2.0%. Comment: Total cholesterol is high and blood pressure is not controlled, but the patient has no other risk factors.

These examples illustrate a key point: under the new guidelines, some patients with very high cholesterol may not need statins, while others with relatively "normal" cholesterol levels might be recommended for treatment — all because the 10-year risk calculation plays the central role in decision-making.

Clinical Implications for Patients

For patients, these guidelines represent a meaningful shift in how doctors will approach cholesterol management. The overall direction is clear: treatment will move toward statins and away from other cholesterol-lowering agents, and this will apply to a broader range of patients than the previous recommendations did.

Some patients may notice that their doctor no longer orders routine LDL cholesterol blood tests to check whether they've hit a target number. Others may be started on higher doses of statins than they were previously prescribed. Patients who have been taking non-statin medications, such as ezetimibe (Zetia) or niacin, may be advised to stop them if they are tolerating their statin well.

Patients over 75 without known heart disease may find that their doctor is more hesitant to prescribe a statin, while younger patients with risk factors like smoking, diabetes, or high blood pressure may be offered statins even if their cholesterol numbers look reasonably good on paper.

It's important to understand that the decision about who should take a statin hinges on a 10-year risk calculation performed with the new online tool. Patients who want to understand their own risk can ask their doctor to walk them through the calculation, which factors in age, sex, race, total cholesterol, HDL cholesterol, systolic blood pressure, blood pressure medication use, diabetes status, and smoking status.

Study Limitations

This analysis is a commentary and practical summary rather than a new research study, so it carries certain limitations. The authors note that the new risk calculator has not been prospectively validated, meaning it has not yet been proven to accurately predict real-world outcomes in diverse populations. The debate over whether it overestimates risk — as Ridker and Cook suggest — remains unresolved at the time of publication.

The guidelines themselves are based largely on randomized, controlled trials of fixed statin doses, and the authors acknowledge that some elements of the recommendations are considered by some observers to be not fully evidence-based. In particular, the lack of evidence supporting non-statin therapies and the treatment of patients over 75 without known heart disease remain areas of uncertainty.

Additionally, the case examples provided in the article are hypothetical illustrations, not recommendations for actual individual patients. Real-world treatment decisions should always be made in consultation with a physician, taking into account the patient's complete medical history and personal preferences.

Recommendations for Patients

Based on this analysis of the 2013 ACC-AHA cholesterol guidelines, here are practical takeaways for patients:

1. Know your 10-year risk. Ask your doctor to calculate your 10-year risk of heart attack or stroke using the new online calculator. This number — not just your cholesterol level — should drive the conversation about statin therapy.
2. Understand your statin intensity. If you are prescribed a statin, ask whether it is high-intensity (lowering LDL by 50% or more) or moderate-intensity (lowering LDL by 30% to less than 50%). Make sure the dose you receive matches what the guidelines recommend for your risk group.
3. Don't be surprised if your LDL isn't checked as often. Under the new guidelines, routine monitoring of LDL levels is no longer emphasized because specific target numbers have been abandoned.
4. Ask before continuing non-statin cholesterol drugs. If you take medications like ezetimibe, niacin, or bile acid sequestrants, ask your doctor whether they are still appropriate, since the guidelines found no evidence supporting their use.
5. If you're over 75, discuss the risks and benefits carefully. The guidelines are more cautious about statins in healthy adults over 75 who do not have established heart disease.
6. Monitor for side effects. If you take statins, be aware of muscle pain or weakness, signs of liver problems, and the small increased risk of new-onset diabetes. Report any concerns to your doctor promptly.

Frequently Asked Questions

Who should consider taking statins under the 2013 cholesterol guidelines?

The guidelines identify four groups who clearly benefit from statins: people with established atherosclerotic cardiovascular disease, those with very high LDL cholesterol (190 mg/dL or higher), adults aged 40–75 with diabetes and LDL between 70–189 mg/dL, and those with a calculated 10-year risk of heart attack or stroke of at least 7.5% and LDL of 70 mg/dL or higher.

What is the new risk calculator and why is it controversial?

The risk calculator estimates a person's 10-year chance of a heart attack or stroke using factors like age, sex, race, cholesterol, blood pressure, and smoking. It is controversial because researchers Ridker and Cook found it may overestimate risk, potentially leading to unnecessary statin prescriptions. The calculator has not been prospectively tested in real-world settings.

Which patients should NOT take statins according to the guidelines?

Guidelines do not support statins for healthy adults over 75 without established heart disease, patients needing hemodialysis, or those with symptomatic heart failure (NYHA class II–IV). No evidence supports non-statin drugs like ezetimibe or niacin in combination with statins or as replacements in patients who cannot tolerate statins.

Will I still need routine LDL cholesterol blood tests if I take a statin?

Under the new guidelines, routine LDL cholesterol testing is no longer emphasized for patients on statins. Because target levels have been abandoned, doctors may not order regular LDL blood tests. However, monitoring for potential side effects like muscle injury, liver injury, or new-onset diabetes is still important.

I am over 75 and healthy. Should I take a statin?

The 2013 ACC-AHA guidelines are more cautious about statins in healthy adults over 75 who do not have established cardiovascular disease. The guidelines do not support statin therapy for this group. If you are over 75 and have no heart disease, discuss the risks and benefits carefully with your doctor.

What side effects of statins should I monitor for?

While taking statins, be aware of muscle pain or weakness, signs of liver problems such as unexplained tiredness or jaundice, and a small increased risk of new-onset diabetes. The guidelines recommend monitoring for muscle injury and liver injury. Report any concerning symptoms to your doctor promptly.

Source Information

Original article title: T h e n e w e ng l a n d j o u r na l o f m e dic i n e

Authors: John F. Keaney, Jr., M.D., Gregory D. Curfman, M.D., and John A. Jarcho, M.D.

Publication: The New England Journal of Medicine, published November 27, 2013. DOI: 10.1056/NEJMms1314569.

Author affiliation: University of Massachusetts Medical School, Worcester (J.F.K.).

Key references cited in the original article:

• Stone NJ, Robinson J, Lichtenstein AH, et al. ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation 2013 (Epub ahead of print).
• National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III). Third Report. Circulation 2002;106:3143-421.
• Ridker PM, Cook NR. Statin guidelines and the prevention of cardiovascular disease. Lancet (in press).
• Prevention guidelines tools: CV risk calculator. Dallas: American Heart Association, 2013.

This patient-friendly article is based on peer-reviewed research published in The New England Journal of Medicine. It is intended for educational purposes and is not a substitute for professional medical advice. Patients should always consult their healthcare provider regarding their individual treatment plan.