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Cardiology Groups Release New Guidelines on Non-Statin Drugs to Lower Cholesterol

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May 4, 2016

Cholesterol-lowering drugs known as statins have been used in the U.S. for decades, but the drugs are not effective for all patients. Last year, the U.S. Food and Drug Administration (FDA) approved two new non-statin drugs called PCSK9 inhibitors for people who do not respond sufficiently to statin therapy. (Read New Drugs Approved for People with Hard to Treat High Cholesterol). Now, the American College of Cardiology (ACC) and the American Heart Association (AHA) have issued new guidelines for healthcare practitioners on using these and other non-statin drugs in adults.

High cholesterol, specifically an increased level of low-density lipoprotein cholesterol (LDL-C), is linked to an increased risk of cardiovascular disease (CVD). Excess cholesterol in the blood may be deposited in plaques on blood vessel walls, leading to hardening of the arteries (atherosclerosis) and increased risk of heart attacks and stroke. Blood tests are used to check cholesterol levels and help determine CVD risk.

In 2013, the ACC and AHA issued guidelines for adults that made recommendations on who should receive cholesterol-lowing therapy, depending on age, presence of heart disease and/or diabetes, and LDL-C level. In healthy adults with no heart disease, the decision to treat is based on a risk calculator that takes into account several factors (e.g., age, gender, race, blood pressure, cholesterol level) and determines their risk of having a heart attack or stroke in the next 10 years. A person with a 7.5% or higher risk should be prescribed statins, regardless of their LDL-C numbers, say the guidelines. (Read Experts Announce Major Updates to Guidelines for Heart Disease Risk Assessment and Prevention).

After a baseline fasting lipid profile and starting treatment with a statin, LDL-C levels are checked at regular intervals to assure that the statin is working. It is recommended that a second fasting lipid profile be done 4 to 12 weeks after starting therapy and then every 3 to 12 months thereafter. If the drug does not result in adequate reduction in LDL-C, a healthcare provider may increase the amount of drug or possibly add a second drug.

The new guidelines from ACC/AHA make recommendations also based on age, LDL-C level, and presence of CVD or diabetes. One of the first line drugs to consider for patients who need additional cholesterol-lowering help may be a drug called ezetimibe, which lowers LDL-C levels by reducing cholesterol absorption in the small intestine. For example, the drug may be appropriate for high-risk patients with CVD who haven't seen their LDL-C level drop by at least fifty percent on statin drugs. If ezetimibe doesn't reduce the LDL-C levels down sufficiently, then a PCSK9 inhibitor or drugs called bile-acid sequestrants can also be considered, depending on the person's clinical status and preferences.

Patients are advised to have a conversation with their healthcare practitioners about the risk and benefits of the different cholesterol drug therapies and what is best for them. Decisions may be based on factors such as LDL-C test results, their level of risk for CVD, and possible side effects from medications. It is important to remember that guidelines such as these provide general recommendations and decisions should take into account the unique circumstance of each individual.

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O'Riordan, Michael. (April 1, 2016) ACC Updates LDL-Cholesterol Lowering Recommendations, Making Room for Ezetimibe and PCSK9 Inhibitors. TCTMD. Available online at http://www.tctmd.com/show.aspx?id=134620. Accessed April 17, 2016.

Herman, Amy. (April 4, 2016) Heart Groups Issue Guidelines on Non-Statin Therapies for LDL-Lowering. NEJM Journal Watch. Available online at http://www.jwatch.org/fw111390/2016/04/04/heart-groups-issue-guidelines-non-statin-therapies-ldl?query=pfwRSTOC&jwd=000020042125&jspc. Accessed April 17, 2016.

Lloyd-Jones DM, Morris PB, Ballantyne CM, Birtcher KK, Daly Jr DD, DePalma SM, Minissian MB, Orringer CE, Smith SC. 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: a report of the American College of Cardiology Task Force on Clinical Expert Consensus Documents. J Am Coll Cardiol 2016. Available as pdf at http://content.onlinejacc.org/article.aspx?articleID=2510936#tab1. Accessed April 17, 2016.