Panelists Debate ACC/AHA Guidelines for Treating High Cholesterol

San Francisco—In November 2013, the American College of Cardiology (ACC) and the American Heart Association (AHA) released new guidelines for treatment with lipids and recommended the use of statins for millions of more adults, including most patients with type 2 diabetes. This was the first update since the National Heart, Lung and Blood Institute (NHLBI) released its most recent Adult Treatment Panel guidelines in 2001, which were modified in 2004.

The federal government decided last year that the National Institutes of Health should no longer support guidelines for risk reduction. The ACC and AHA then reviewed the work the NHLBI panel had performed and assumed responsibility for publishing the guidelines. All but 2 of the 16 NHLBI committee members remained on board when the ACC and AHA took over. At the ADA meeting, panelists debated the guidelines and discussed changes that altered the way patients with or without type 2 diabetes are treated.

Guideline Highlights
There were similarities between the 2004 and 2013 guidelines, including an emphasis on lifestyle changes, such as increased exercise and improved diet, a focus on treating low-density lipoprotein (LDL) cholesterol, and a preference for using statins rather than other medications to lower LDL cholesterol. However, the new guidelines mentioned that nonstatin therapies do not reduce the risk of atherosclerotic cardiovascular disease (CVD) and dismiss having goals for LDL and non–high-density lipoprotein (non-HDL) cholesterol because they are not evidence-based, according to Robert H. Eckel, MD, professor of medicine, University of Colorado. Dr. Eckel served on the ACC/AHA blood cholesterol guideline panel that was chaired by Neil J. Stone, MD, preventive cardiologist, Northwestern University. Dr. Eckel said doctors could still choose to use the cholesterol goals, though evidence does not show they are helpful.

“We knew this was going to be problematic, but because of the stringency of the recommendations that followed the evidence-based review [and] because the clinical trials were not really targeted to specific levels of LDL and non-HDL cholesterol, the committee felt that we could not recommend levels,” said Dr. Eckel, who was also co-chairman of the ACC/AHA lifestyle working group. “That does not mean that the levels cannot be utilized in practice. They are just not evidence-based. A physician in her or his practice can make a decision to set levels that [he or she is] comfortable with based on reading the guidelines and having an educated knowledge of patients who may need ultimately goal-setting to create a level of comfort in their clinical care.”

The ACC/AHA panel was asked to evaluate evidence from randomized, controlled trials that examined cholesterol-lowering drug therapies to reduce atherosclerotic CVD risk. Dr. Eckel said he and his fellow committee members followed the Institute of Medicine’s (IOM) definition of evidence-based statements. The IOM recommends using meta-analyses and systematic reviews of randomized, controlled trials and discourages expert opinions. “Nobody has claimed that this guideline is perfect for patients with or without diabetes, but it is clearly the most evidence-based recommendations we have ever had,” Dr. Eckel said.

The committee found 4 groups that would most likely benefit from taking statins: (1) people with clinical atherosclerotic CVD; (2) adults with LDL cholesterol ≥190 mg/dL; (3) individuals 40 to 75 years of age who have diabetes and an LDL cholesterol from 70 mg/dL to 189 mg/dL; and (4) individuals 40 to 75 years of age who do not have diabetes but have an LDL cholesterol from 70 mg/dL to 189 mg/dL and a ≥7.5% risk of atherosclerotic CVD within 10 years.

If patients do not fit into those 4 groups, Dr. Eckel said healthcare professionals could examine other factors, such as family history of premature atherosclerotic CVD, elevated lifetime risk of atherosclerotic CVD, LDL cholesterol ≥160 mg/dL, high sensitivity C-reactive protein ≥2 mg/dL, and subclinical atherosclerosis.

The ACC and AHA also released an atherosclerotic CVD risk estimator based on the National Health and Nutrition Examination Survey that included 12 years of follow-up from a diverse population in the United States. The risk estimator is based on age, race, gender, total cholesterol, HDL cholesterol, blood pressure (BP), diabetes status, and smoking status. Individuals 20 to 59 years of age receive a 10-year and lifetime risk score. Dr. Eckel said the risk estimator should be used as a guide and should not replace clinical decision-making.

Opposing Views
Henry Ginsberg, MD, professor of medicine, Columbia University, who was not involved in developing the guidelines, said the recommendations were too rigid. In addition to randomized, controlled trials, he hoped the committee could have also evaluated data from animal models, cohort studies, population trials, and smaller studies.

“I think it left the committee with the inability to really use 100 years of data that all of us in this field have grown up with,” Dr. Ginsberg said. “I think that is an error that the committee was forced into. I give them great credit for moving beyond the use of LDL cholesterol to initiate therapy. After that, my own assessment is that the restrictions under which they worked produced a document that falls short, particularly for groups like people with diabetes.”

Dr. Ginsberg added that although statins are the “gold standard,” he wished the guidelines had given physicians more leeway in terms of recommending other treatment options besides statins. Since the guidelines were released in November 2013, payers are less likely to pay for drugs other than statins to treat type 2 diabetes, according to Dr. Ginsberg.

“The report has been chastised, and the criticism has been hyped to the point where people have said, ‘Put a patient on a statin and say goodbye,’” he said. “I think there were mixed messages that came out, and I do believe that while statins are the gold standard and the evidence for statin use is clear in these groups of people, that expert opinion or something between the gold standard and expert opinion could have been used to say that patients at very high risk based on the data that are available, they should be on something else to lower their LDL [cholesterol].”

Individualized Treatment
Dr. Eckel played a major role in developing the guidelines, but he emphasized that they are not requirements and that doctors should make individual choices based on each patient. He said that 80% of the decisions he makes in his practice go beyond the guidelines. For instance, he interviews each patient for a few minutes and asks them about their diet, including the number of servings of fruits, vegetables, and whole grains they have on a daily basis.

Dr. Eckel said the panelists determined that a healthy lifestyle related to improvements in nutrition and physical activity reduces the risk of CVD. He cited a study that found between 1990 and 2010 the incidence of diabetes-related complications have decreased, including acute myocardial infarction by 67.8%, stroke by 52.7%, amputations by 51.4%, end-stage renal disease by 28.3%, and death from hyperglycemic crisis by 64.4% [N Engl J Med. 2014;370(16):1514-1523]. The reduced risk of macrovascular disease can be attributed to the availability of statins, fewer people smoking, and improvements in BP control.

“Physicians are not robots,” he said. “The guidelines are meant to inform, not to mandate. We need people who have read the guidelines, applied them, and then go beyond them when we feel that is necessary. At all ages, the discussion between the prescribing physician and the patient is absolutely essential. We do not force a statin on anybody. We want them to know the evidence for benefit versus risk and make cogent decisions clinically about who to give a drug to.”—Tim Casey