Cholesterol: The new guidelines
Ann K. McCullough
Northern Illinois University

Background
There are 71 million American adults that have elevated low-density lipoproteins (LDL) cholesterol and only 33% of adults with high LDL’s are being treated (CDC, 2012). Dyslipidemia is a major risk factor for coronary artery disease (CAD) and it has shown to be a contributing factor for CAD. An estimated 785,000 Americans will have a new CAD event and approximately 470,000 will have a recurrent attack. The cost of CAD is astounding and is estimated at $172 billion annually (Heidenreich, el. al., 2011). Cardiovascular disease (CVD) is the leading cause of death in the United States (US) and is responsible to 17% of the national health expenditures.
It has been eight years since new cholesterol guidelines have been updated and the new guidelines have created a little controversy. The ATP IV guidelines set by the American College of Cardiology/American Heart Association (ACC/AHA) have created many waves in the treatment of cholesterol and lipid management. The guidelines stress the prevention of stroke as well as heart disease and focuses on statin therapy rather than other alternative unproven therapeutic agents. It also recognizes that more intensive treatment is superior to less intensive treatment for many patients.
History
Cholesterol screening guidelines have evolved and changed over the past couple of years, but there continues to be gaps in care with an insufficient number of patients receiving standard of care with lipid-lowering therapy. The numerous guidelines set out by specialty practices have been shown to be a contributing factor to suboptimal management of cholesterol management. The new ATP IV guidelines established by the ACC/AHA have sparked considerable controversy from the previous ATP III guidelines and many professional organizations are not accepting the new guidelines into practice. The new guidelines document a major shift in the treatment of LDL cholesterol and reducing the risk of atherosclerotic cardiovascular disease (ASCVD) in adults.
Purpose
The AHA has created a set of impact goals for 2020 and one of those goals was to improve the cardiovascular health of all Americans by 20% while reducing the deaths from CVD and stroke by 20% (Go, et. al., 2013). The new cholesterol screening guidelines from the ACC/AHA were created to help meet that goal. It is estimated that in 2030, 40.5% of the US population will have some form of CVD thus making primary prevention at the forefront of care (Heidenreich, el. al., 2011). Through the use of primary prevention many patients will be prescribed a statin medication to reduce their risk of ASCVD. It is imperative that the primary care provider stresses the importance of lifestyle modification including adhering to a heart healthy diet, regular exercise, avoiding tobacco products, and maintaining a healthy weight. These modifications remain a critical component of health promotion and ASCVD risk reduction.
The ACC/AHA guidelines used high-quality clinical trial evidence to show the benefits and/or harms of statin use do not vary based on a person LDL level. The new guidelines have created many controversies and one professional organization; the American Association of Clinical Endocrinologist (AACE) doesn’t support the new guidelines.
The ACC/AHA vs. AACE Guidelines
According to the ACC/AHA guidelines there is no longer a target specific LDL cholesterol level, but recommend lipid-lowering therapies of varying intensity based on the patients predicted risk of cardiovascular events or to reduce the ASCVD risk. Implementation of the new guidelines would result in millions more American’s receiving high-potency statins. The guidelines emphasize that individuals where statin therapy is indicated prove that the benefits of reducing heart attack, stroke, and cardiovascular death significantly outweigh the risks of developing diabetes or myopathy (Ridker & Cook, 2013). The AACE agrees that the use of statins is the treatment of choice for patients with dyslipidemia however they disagree with the removal of LDL cholesterol goals and that statin monotherapy is sufficient for all at-risk-patients (AACE, 2013).
The new guidelines have four treatment groups that include: individuals with clinical ASCVD, individuals with LDL-cholesterol levels greater or equal to 190 mg/dL, such as those with familiar hypercholesterolemia, individuals with diabetes aged 40-75 years old with LDL-cholesterol levels between 70 and 189 mg/dL and without evidence of ASCVD, and individuals without evidence of cardiovascular disease or diabetes but who have LDL-cholesterol levels between 70 and 189 mg/dL and a 10-year risk of atherosclerotic cardiovascular disease exceeding 7.5% (O’Riordan, 2014). These four treatment groups should be treated with statins. The AACE believes that many patients are being overlooked by these four treatment groups and would not be considered for treatment. The groups were identified on the basis of randomized, controlled clinical trials. The trials showed that the benefit of treatment outweighed the risk of adverse events. The AACE thinks that one area of contention with the new AHA/ACC guidelines is that it is focused exclusively on randomized clinical trials and for not including studies published since 2011 (Tucker, 2013).
Another reason the AACE doesn’t support the new guidelines is due to the fact that the AHA/ACC guidelines don’t convey their own recommendations. The following are the guidelines that the AACE uses are: treatment of blood cholesterol in adults, lifestyle management to reduce cardiovascular risk, obesity management, in conjunction with The Obesity Society, and a “science advisory” on the management of hypertension, along with the CDC (Tucker, 2013). Another area of contention is the removal of the LDL targets and the idea that statin therapy alone is sufficient for all at-risk patients. The AACE is concerned that many patients have multiple risk factors including diabetes and established heart disease and that additional therapies may be needed with combination drug therapy. The AACE also recommends determining the 10-year risk of a patient having a coronary event using the Framingham Risk Assessment Tool or Reynolds Risk Score.
The ACC/AHA also added a cardiovascular disease calculator into the guidelines. The cardiovascular disease calculator that was published along with the guidelines according to the AACE is already outdated. The AACE thinks that it is based on outmoded data and the model doesn’t take into consideration the entire US populations, hasn’t been validated, and therefore has only limited applicability (Jellinger, et. al., 2012). In the end the AACE welcomes the intent of the AHA/ACC creation of the new guidelines, but doesn’t agree with the complete content and therefore cannot endorse them.
Although there is a great deal of controversy with the new ACC/AHA cholesterol guidelines by implementing them in primary care there will be an improvement in cardiovascular outcomes. Both the ACC/AHA and AACE guidelines use lifestyle modification as the first line step for addressing cardiovascular risk in most patients with elevated cholesterol levels. The ACC/AHA guidelines succeed in prioritizing statin therapy, expanding the focus on ASCVD, and emphasizing absolute cardiovascular risk to determine statin therapy appropriateness.
Literature Review There are several studies that have shown a strict adherence to lipid-lowering medications improves outcomes for patients who are at risk for or have had a cardiovascular event. According to a study done by LaRosa in 2005, which showed that the use of intensive atorvastatin therapy to reduce LDL cholesterol levels below 100mg/dL is associated with substantial clinical benefit in patients with stable coronary heart disease (CHD). It also showed that CHD is ideally well controlled at an LDL level of approximately 100mg/dL. The data from this study confirmed the growing body of evidence that indicated lowering LDL cholesterol levels well bellow currently recommended levels can have clinical benefit. The benefits of this study were used to establish the ACC/AHA guidelines in using statins to reduce the mortality of ASCVD through primary prevention. In a study done by Pencina, et. al. (2014) that used data from the National Health and Nutritional Examination Surveys of 2005 to 2010 it showed that the new ACC/AHA guidelines would increase the number of adults who would be eligible for statin therapy by 12.8 million, including 10.4 million for primary prevention. The increase will be seen mostly in older adults without cardiovascular disease. The study compared the new guidelines with the ATP-III guidelines, which showed that the new guidelines would recommend statin therapy for more adults. There are two groups of adults that statin therapy would be recommended those that would be expected to have future cardiovascular events and those who would not have future events. In a systematic review done by Taylor, el. al. (2013) that used randomized control trials of statin versus placebo or usual care control with minimum treatment duration in adults with no restrictions on total, LDL, or high-density lipoprotein (HDL) levels and 10% or less of the patients had a history of CVD. The review showed that reduction in mortality, major vascular events, and revascularization were found with no increase in adverse events among people without evidence of CVD treated with statins. All of the studies reviewed showed a reduction in total cholesterol and LDL cholesterol. The review concluded that primary prevention with statins is likely to be a cost effective approach that will likely improve quality of life. This was one of the many reviews used by the expert panel that created the ACC/AHA guidelines.
Multicultural Issues The ACC/AHA guidelines emphasize lifestyle modification as the foundation for decreasing risk, regardless of cholesterol therapy. The guidelines didn’t give recommendations for patients with New York Heart Association class II, III, or IV heart failure or for hemodialysis patients because there was insufficient data from randomized controlled trials to support recommendations (Raymond, et. al., 2014). The guidelines also only apply to people between the ages of 40 and 75 (risk calculator ages 40-79) because the authors believed there was insufficient evidence from randomized controlled trials to allow development of the guidelines outside this age range. The guidelines have the potential to over treat older low-risk patients and undertreat those who are young but have a higher lifetime risk.
Risk Reduction The ACC/AHA guideline for cholesterol screening and treatment focuses on ASCVD risk-reduction by reducing CVD events through primary and secondary prevention (Stone, et. al., 2013). The guidelines recommends using the new Pooled Cohort Equations to estimate the 10-year ASCVD and the appropriate treatment either through lifestyle modifications or statin therapy that should reduce the ASCVD risk. The new risk equation calculator uses an increased population sample and includes different ethnicities; it also is derived from more than one geographical area. This makes it more patient specific than the previous risk score calculators.
Financial
Between 2010 and 2030 the total direct medical cost of CVD are projected to triple from $273 billion to $818 billion and the real indirect costs for all CVD are estimated to increase from $172 billion in 2010 to $276 billion in 2030, an increase of 61% (Heidenreich, el. al., 2011). This is one major reason why primary prevention is key to reducing the cost of CVD and the many complication that can result from CVD. The cost of CAD is one reason that primary prevention is key. Statins have become the treatment of choice for primary prevention and there are many low cost generics available to patients.
Conclusion
The ACC/AHA guidelines place emphasis that primary care provider decision-making should play a vital role in choosing the most appropriate treatment options. Amid the controversy the new guidelines succeed in prioritizing statin therapy, emphasizing cardiovascular risk to determine statin therapy appropriateness, and expanding the focus to ASCVD. Both the patient and provider need to work together to decrease cholesterol levels through lifestyle modification and statin therapy. In the end the new guidelines represent a step forward in the prevention of elevated cholesterol and decreasing the risk of both heart attack and stroke.

References
Cholesterol (2012). Centers for Disease Control and Prevention. Retrieved from http://www.cdc.gov/cholesterol/facts.htm
American Association of Clinical Endocrinologists (2013). AACE does not endorse AHA/ACC lipid and obesity guidelines.
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Jellinger, P.S., et. al. (2012). AACE task force for the management of dyslipidemia and prevention of atherosclerosis writing committee. Endocrine Practice, 18(1): 1-78
La Rosa J.C., Grundy S.M., Waters D.D., et al. (2005). Intensive lipid lowering with atorvastatin in patients with stable coronary disease. New England Journal of Medicine, 352: 1425-1435.
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Tucker, M.E. (2013). Endocrinology group rejects new AHA/ACC CVD guidelines. Medscape. December 13, 2013. Retrieved from http://www.medscape.com/viewarticle/817810.