January 19, 2019
Patient asking about a prescription.

Cholesterol Guidelines: What's New?

by Wellness Letter

It has been five years since the last update of the official guidelines for managing cholesterol from the American College of Cardiology and the American Heart Association (ACC/AHA). The 2013 guidelines were a dramatic change in that they set aside the long-standing numeric targets for cholesterol and focused instead on treating people (seemingly many more people) who are deemed to be at elevated risk for cardiovascular disease (CVD) and are most likely to benefit from treatment—with the emphasis almost entirely on statin drugs, if lifestyle changes don’t help enough.

New ACC/AHAguidelines, released in November 2018, keep the 2013 framework but add steps to further personalize risk assessment and the decision process about treatment. They also emphasize more that when it comes to LDL (“bad”) cholesterol, lower is better—sometimes much lower—especially for people who already have CVD or who have multiple risk factors for it. To achieve this greater LDL lowering, the guidelines include the option of adding non-statin drugs for people at high risk.

Note: Keep in mind that the new guidelines, like earlier ones, are just starting points, not strict rules. They are intended to help you and your health care providers make decisions, not to dictate them.

Who needs statins?

One change in the ACC/AHA guidelines is that they now say it is not necessary to fast before having blood drawn for initial lipid screening (cholesterol and triglycerides). Regardless of the test results, the guidelines stress even more now that people should be encouraged to take lifestyle steps (such as improving diet, exercising more, and losing weight if overweight) to improve their cholesterol levels and other CVD risk factors.

Based on the test results and an evaluation of risk factors, the guidelines still say that three groups are automatically considered at high risk and are thus candidates for statins and possibly additional drugs:

  • People with a history of CVD, such as a heart attack, angina, or stroke.
  • People ages 40 to 75 who have diabetes (which greatly increases CVD risk).
  • People with very high LDL (above 190 mg/dL), often the result of familial hypercholesterolemia.

If you are between the ages of 40 and 75 and don’t fit into the above categories, the guidelines recommend using a risk calculator, such as the one from the ACC found at ASCVD Risk Estimator Plus.

The calculator determines your 10-year risk of a major CVD event. It takes into account the following factors: age, gender, race, cholesterol levels (total, LDL, and HDL), blood pressure, presence of diabetes, whether you smoke, and whether you take aspirin, a statin, or blood pressure medication.

If your 10-year risk is below 5 percent, you are at low risk and are not a candidate for a statin. Here are the other risk categories and what the guidelines recommend:

HIGH RISK (10-year risk above 20 percent): You should take a high-dose statin to reduce LDL by at least 50 percent.

INTERMEDIATE RISK (10-year risk 7.5 to 20 percent): Talk with your doctor about your major risk factors (such as smoking, hypertension, obesity, and inactivity). In addition, the guidelines now call for an evaluation of other “risk-enhancing factors,” such as:

  • Family history of premature CVD. For males, that means a heart attack or stroke before age 55; for females, before age 65.
  • Persistently elevated LDL (160 to 190 mg/dL).
  • Persistently elevated triglycerides (175 mg/dL or above).
  • Metabolic syndrome, characterized by three or more of the following: abdominal obesity, high blood pressure, high blood sugar, high triglycerides, and low HDL (“good”) cholesterol.
  • Chronic kidney disease.
  • High-risk ethnicity (such as South Asian).
  • Chronic inflammatory disorders (such as rheumatoid arthritis or psoriasis) or HIV/AIDS.
  • History of early menopause (before age 40) or pregnancy-related conditions that increase CVD risk, such as preeclampsia.

If you decide to start treatment on the basis of this evaluation (plus a discussion about the pros and cons of statins), the goal is to reduce LDL cholesterol by at least 30 percent with a moderate-intensity statin. If you and your doctor remain uncertain about treatment, a coronary artery calcium (CAC) scan may help.

BORDERLINE RISK (10-year risk 5 to 7.5 percent): You may also be a candidate for statins, depending on your risk factors, as discussed under intermediate risk.

What about people under 40 or over 75?

The treatment guidelines focus primarily on people ages 40 to 75 because almost all of the major clinical trials have involved that age group. They do advise people under 40 or over 75 with CVD, diabetes, or very high LDL to take statins. For others in these age groups, the benefits and risks of statin therapy should be considered on an individual basis. Young adults (ages 20 to 39) should have their risk factors evaluated and be advised on how to improve them.

Doctors are generally advised to be cautious in starting statin therapy in people over 75 without CVD. Even though older people have the highest risk of heart attack and stroke and thus have the most to gain, they’re also more likely to suffer adverse effects from statins, largely because of medical conditions they have and interactions with other drugs. But the new guidelines emphasize that older people may still be candidates for statins.

Once treatment is started

If you are at elevated CVD risk and decide to focus solely on lifestyle modification first or opt for a statin, the guidelines advise having your LDL measured again (this time fasting) after 4 to 12 weeks to assess your progress, then retesting every 3 to 12 months based on determined needs. If statin therapy does not produce the desired reduction in LDL, the new guidelines map out the non-statin options that should be added.

When to turn to non-statins

The updated guidelines put new emphasis on more intensive lowering of LDL cholesterol for higher-risk people—and on the selective use of non-statin drugs to help accomplish this. This change in recommendations came about because of the publication of important clinical trials that examined the effectiveness and safety of adding the newer drugs to statin therapy.

In some people at elevated risk, even high-dose statins don’t lower LDL the desired 30 or 50 percent. And some individuals can’t tolerate high-dose statins because of adverse effects. For such people, the guidelines now advise that additional medication be prescribed in a stepped approach. This is also recommended for people with a history of CVD and those otherwise at very high risk, if their LDL cholesterol remains above 70 mg/dL despite statin therapy. That is the only numeric target in the new guidelines.

The first drug to add is ezetimibe (brand name Zetia), which can lower LDL an additional 20 percent. Like statins, this is now available as a generic.

If the addition of ezetimibe doesn’t reduce LDL enough in people at very high risk, the guidelines say a PCSK9 inhibitor would be a “reasonable” adjunct to a statin. These expensive drugs—alirocumab (Praluent) and evolocumab (Repatha)—are self-injected once or twice a month and can reduce LDL by an additional 60 percent. PCSK9 inhibitors have been approved only for people who have CVD or very high LDL.

The guidelines do not recommend routine use of non-statin drugs for people at borderline or intermediate cardiovascular risk, since any additional benefit is likely to be marginal. If further lowering of LDL cholesterol is warranted for them, increasing statin dosage is the preferred option.

As with statin therapy, any decision about a non-statin drug calls for a discussion between patient and doctor to assess individual risk factors, the benefits and risks of treatment, potential drug interactions, patient preferences, and cost (at least if a PCSK9 inhibitor is being considered).

Bottom line

While statins have played a major role in the dramatic decline in mortality rates from heart disease since the 1980s, they and other drugs can’t replace a healthy lifestyle. An abundance of research supports the benefits of a heart-healthy diet (such as the Mediterranean diet or DASH plan), exercise, not smoking, and weight control—which not only improve cholesterol levels, but also help protect cardiovascular health in other ways. Even if you take cholesterol-lowering medication, these steps are still essential.

Also see Adverse Effects of Statins: What to Do.