New Cholesterol Treatment Guidelines Recommend Statins for More Patients

The American College of Cardiology (ACC) and the American Heart Association (AHA) released new cholesterol treatment guidelines in November 2013. The new guidance, called the “Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Disease Risk in Adults,”[1],[2] was meant to replace previous guidelines published in 2002 and updated in 2004.[3]

As with the new hypertension guidelines covered in our September issue, the ACC/AHA cholesterol treatment guidelines have been a focus of controversy.[4]

About cholesterol

A fat-like substance found in the blood and most body tissues, cholesterol is obtained from various types of foods — such as meat, milk, potato chips, cookies and eggs — but is mostly produced by the liver. Cholesterol levels are checked through a blood test called a lipoprotein profile or lipid panel.

High blood cholesterol increases the risk for atherosclerotic cardiovascular disease, which causes thickening and narrowing of the blood vessels and leads to heart attacks, strokes and other disorders. These conditions are the leading cause of death, decreased quality of life and medical costs among men and women in the United States, but most of them are preventable through a healthy lifestyle and effective management of cholesterol and blood pressure.

The new recommendations

The new guidelines differ from the 2004 guidance in major ways. For example, they are based only on evidence from randomized clinical trials and exclude observational studies.[5] The trials used to form the new guidelines were largely conducted among patients treated with statins — the most commonly used class of drugs that block the production of cholesterol in the body.

Additionally, the new guidelines do not focus on reaching certain target cholesterol levels, such as bringing the low density lipoprotein (LDL) cholesterol (sometimes called “bad cholesterol”) level down to 100 or lower. Instead, the guidelines recommend determining a patient’s risk of atherosclerotic cardiovascular disease using a new calculator[6] that considers risk for both heart disease and stroke, as opposed to just heart disease risk. This new score uses more pieces of information about a patient (including age, race, sex, blood pressure, smoking history and diabetes status) to generate an overall assessment of the risk for developing cardiovascular disease over the next 10 years.

According to the new guidelines, patients with LDL higher than 70 and a 7.5 percent or higher chance of developing atherosclerotic cardiovascular disease within the next 10 years should be treated with statin therapy. On the other hand, the 2002 guidelines generally recommended statin therapy for patients with LDL higher than 100 and a 20 percent or higher chance of developing coronary heart disease within the next 10 years.[7]

Generally, the ACC/AHA guidelines state that the benefits of using statins outweigh the harms in four groups of patients for either secondary prevention (to prevent the occurrence of new cardiovascular events in patients with a prior cardiovascular event; for example, to prevent a second heart attack in a patient who already had a heart attack) or primary prevention (to prevent the occurrence of cardiovascular events in patients with no prior events). As shown in the table on page 4, these four groups are (1) patients with prior cardiovascular events, (2) patients age 21 or older with LDL 190 or higher, (3) patients age 40 to 75 with diabetes and with LDL between 70 and 189, and (4) patients age 40 to 75 with LDL between 70 and 189 and with elevated (7.5 percent or greater) 10-year risk of atherosclerotic cardiovascular disease.

Four Patient Groups Recommended for Statin Therapy in the ACC/AHA Guidelines

* High-intensity statin therapy options include the following drugs and daily doses: atorvastatin (LIPITOR) 40 or 80 mg, or rosuvastatin (CRESTOR)** 20 or 40 mg;
Moderate-intensity statin therapy options include: atorvastatin 10 or 20 mg; rosuvastatin** 5 or 10 mg; simvastatin (ZOCOR) 20 or 40 mg; pravastatin (PRAVACHOL) 40 or 80 mg; lovastatin (ALTOPREV) 40 mg; fluvastatin (LESCOL) 40 mg twice a day, fluvastatin (LESCOL XL)** 80 mg; or pitavastatin (LIVALO)** 2-4 mg.
** Public Citizen’s Health Research Group lists rosuvastatin, fluvastatin and pitavastatin as Do Not Use drugs.

Criticism of the new guidelines

The reliance of the new guidelines on randomized clinical trials — and the exclusion of observational studies — has been criticized. Critics say that using evidence from both study types better determines how the findings of these tightly controlled trials hold in the real world.[8]

Additionally, many researchers and clinicians are concerned about abandoning the use of target cholesterol blood levels to guide treatment. The studies did not consider specific cholesterol levels as targets for treatment, but rather used percentage reduction in cholesterol levels when assessing patient outcomes.

Most importantly, the new cardiovascular disease risk score calculator recommended in the guidelines has been criticized in medical journals because it has not been tested extensively and has been shown to overestimate the 10-year risk of cardiovascular disease.[9] Critics argue that both the lowering of statin treatment thresholds and the adoption of the new risk calculator would, perhaps inappropriately, increase the use of statins substantially if these new guidelines are fully implemented.[10]

For instance, a recent study estimated that compared to the 2002 guidelines, the ACC/AHA guidelines would increase the number of U.S. adults ages 40-75 who are eligible for statin therapy from 43 million (37.5 percent) to 56 million (48.6 percent).[11] This increase would be driven largely by use for primary prevention of cardiovascular events, where the evidence for benefit is not as well-established.

Our impressions

Public Citizen’s Health Research Group agrees with the new guidelines that the benefits of taking cholesterol-lowering drugs outweigh potential harms when used for secondary prevention.

However, we share the concerns raised by many physicians and researchers about the overtreatment of some patients with statins, especially for primary prevention. Particularly, we do not recommend that healthy adults with elevated LDL levels — but with no diabetes or elevated blood pressure — take statins to prevent cardiovascular events.[12] Instead we encourage the use of nondrug measures to lower high cholesterol as first-line therapy. These include keeping a healthy diet, exercising, avoiding smoking and maintaining a healthy weight.

For example, consumers can utilize a guide developed by the National Heart, Lung and Blood Institute (NHLBI) for lowering cholesterol with therapeutic lifestyle changes. These include a healthy diet, exercise, no smoking, and a healthy weight. This guide can be downloaded free of charge here at the NHLBI website.

Statins

As with all cholesterol-lowering drugs, statins should always be used in addition to a diet restricted in saturated fat and cholesterol, along with other healthy lifestyle practices. It is clear that four types of statins (lovastatin [ALTOPREV], pravastatin [PRAVACHOL], simvastatin [ZOCOR] and atorvastatin [LIPITOR]) are safe and effective.[13]

We have long recommended that patients with high cholesterol not use rosuvastatin (CRESTOR) because it is associated with a higher number of cases of rhabdomyolysis (a disorder involving muscle damage) and kidney toxicity and failure compared to the safer four statins.[14] We also have listed fluvastatin (LESCOL, LESCOL XL) and pitavastatin (LIVALO) as Do Not Use drugs because they have not been shown to be as effective in reducing the risk of heart attack or stroke compared to other statins.[15]

Overall, all patients taking any type of statin therapy should be monitored for the following potential adverse events: myopathy (a muscle weakness disease); muscle pain and muscle damage; development of new-onset diabetes; memory loss and confusion; and, rarely, kidney or liver damage. Because statin dosage sometimes needs to be adjusted based on treatment with other medications, patients need to tell their health care providers about all medications they are taking.[16]

What You Can Do

The benefits of using cholesterol-lowering drugs (including statins) in patients with high cholesterol and a history of atherosclerotic cardiovascular disease to reduce further cardiovascular events clearly outweigh the risks of these medications. However, if you have an elevated cholesterol level but you are otherwise healthy, you should work with your health care provider to determine your cardiovascular disease risk and discuss lifestyle changes.

References

[1] Stone NJ, Robinson JG, Lichtenstein AH, et al. 2013 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. J Am Coll Cardiol. 2014;63(25 Pt B):2889-934. doi:10.1016/j.jacc.2013.11.002.

[2] Stone NJ, Robinson, JG, Lichtenstein AH, et al. Treatment of blood cholesterol to reduce atherosclerotic cardiovascular disease risk in adults: Synopsis of the 2013 American College of Cardiology/American Heart Association cholesterol guideline. Ann Intern Med. 2014;160(5):339-344.

[3] Jackevicius CA. How do the 2013 cholesterol guidelines compare with previous cholesterol guideline reports? Circ Cardiovasc Qual Outcomes. 2014;7(2):306-310. doi:10.1161/CIRCOUTCOMES.113.000769.

[4] The Editorial Board. Cholesterol guidelines under attack. New York Times. November 18, 2013. http://www.nytimes.com/2013/11/19/opinion/cholesterol-guidelines-under-attack.html?_r=0. Accessed September 16, 2014.

[5] Stone NJ, Robinson JG, Lichtenstein AH, et al. 2013 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. J Am Coll Cardiol. 2014;63(25 Pt B):2889-934. doi:10.1016/j.jacc.2013.11.002.

[6] American College of Cardiology/American Heart Association. ASCVD Risk Estimator. http://tools.cardiosource.org/ASCVD-Risk-Estimator/#/ASCVD-Risk-Estimator/.

[7] Jackevicius CA. How do the 2013 cholesterol guidelines compare with previous cholesterol guideline reports? Circ Cardiovasc Qual Outcomes. 2014;7(2):306-10. doi:10.1161/CIRCOUTCOMES.113.000769.

[8] Lopez-Jimenez F, Simha V, Thomas RJ, et al. A summary and critical assessment of the 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular disease risk in adults: Filling the gaps. Mayo Clin Proc. 2014; 89(9):1257-1278. doi:10.1016/j.mayocp.2014.06.016.

[9] Ridker PM, Cook NR. Statins: New American guidelines for prevention of cardiovascular disease. Lancet. 2013;382(9907):1762-5. doi:10.1016/S0140-6736(13)62388-0.

[10] Ray KK, Kastelein JJP, Boekholdt SM, et al. The ACC/AHA 2013 guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular disease risk in adults: The good the bad and the uncertain: A comparison with ESC/EAS guidelines for the management of dyslipidaemias 2011. Eur Heart J. 2014;35(15):960-968. doi:10.1093/eurheartj/ehu107.

[11] Pencina MJ, Navar-Boggan AM, D’Agostino RB, et al. Application of new cholesterol guidelines to a population-based sample. N Engl J Med. 2014;370(15):1422-1431. doi:10.1056/NEJMoa1315665.

[12] Redberg RF, Katz MH. Healthy men should not take statins. JAMA. 2012;307(14):1491-1492. doi:10.1001/jama.2012.423.

[13] WorstPills.org. Drug profile: atorvastatin (LIPITOR); lovastatin (ALTOPREV, MEVACOR); lovastatin extended release (ALTOCOR); pravastatin (PRAVACHOL); simvastatin (ZOCOR). https://worstpills.org/member/drugprofile.cfm?m_id=192. Accessed September 12, 2014.

[14] WorstPills.org. Drug profile: rosuvastatin (CRESTOR). /monographs/view/193. Accessed September 29, 2014.

[15] WorstPills.org. Drug profile: fluvastatin (LESCOL, LESCOL XL). /monographs/view/191. Accessed September 29, 2014.

[16] WorstPills.org. Drug profile: atorvastatin (LIPITOR); lovastatin (ALTOPREV, MEVACOR); lovastatin extended release (ALTOCOR); pravastatin (PRAVACHOL); simvastatin (ZOCOR). https://worstpills.org/member/drugprofile.cfm?m_id=192. Accessed September 12, 2014.