Articles address controversy surrounding new cholesterol treatment guidelines

A series of articles in the Annals of Internal Medicine offer suggestions for how to put into practice the new American College of Cardiology/American Heart Association joint practice guidelines for the prevention of CVD.

The guidelines were controversial when released in November in large part due to abandonment of target goals for LDL, HDL and non-HDL in favor of focusing on statin treatment for high-risk patients. Also new was the recommended adoption of a risk score calculator to determine patients at the highest risk for atherosclerotic CVD. Some experts have supported the new guidelines, whereas others have criticized the emphasis on statins and said the calculator overestimates risk.

A ‘middle ground’ for decision-making

In one commentary, Seth S. Martin, MD, and Roger S. Blumenthal, MD, both from the Johns Hopkins Ciccarone Center for the Prevention of Heart Disease, said the new guidelines should not be interpreted as a rigid formula, but rather used as a basis for initiating discussion about risk between clinicians and patients.

Seth S. Martin

They suggested steps to manage the potential limitations of the risk calculator. “A reasonable middle ground might be to expand the definition of intermediate risk from a range of 5% to 7.5% to a range of 5% to 15%,” wrote Martin and Blumenthal, both members of the Cardiology Today Editorial Board. “Patients falling in this range who require greater certainty could then consider their family history or coronary artery calcium score to refine risk assessment.”

The basis behind abandonment of target cholesterol goals in the guideline was that the goals were not supported by evidence from randomized controlled trials, according to the guideline authors. However, Martin and Blumenthal said other evidence exists suggesting that target goals may be useful for some patients.

“A truly evidence-based approach may be to synthesize randomized evidence with other lines of evidence, which supports selective use of LDL or non-HDL targets in high-risk adults,” they wrote.

For example, data from the AIM-HIGH and ACCORD trials suggested potential benefit of add-on therapy for patients with low HDL levels and high triglycerides. According to Martin and Blumenthal, “a follow-up non-HDL goal could guide the treatment of these patients.”

“Our view is that risk- and lipid-based paradigms are not mutually exclusive and could be complementary,” they wrote. “At baseline, obtaining the most accurate assessment of risk is crucial in determining who to treat, whereas in follow-up, lipid measurements can serve as a measure of therapeutic response, promote adherence, motivate lifestyle improvements, and guide discussions about add-on pharmacologic therapy for patients who are clearly established as high-risk.”

Roger S. Blumenthal

Lower risk thresholds of concern

Potential flaws with the new risk calculator are not of great concern because they can be modified in the future, but the lowering of risk thresholds for primary prevention could be a serious concern, John Downs, MD, of the South Texas Veterans Health Care System, San Antonio, and Chester Good, MD, of the University of Pittsburgh, wrote in another commentary.

“Given the uncertainty any calculator in accurately predicting 10-year risk, we believe that the decision to recommend pharmacotherapy for primary prevention should be based on a risk of 10% or 15%,” instead of 7.5%, they wrote. “Once a decision is made to treat lower-risk patients, we are concerned that those who cannot tolerate a statin might then be transitioned to nonstatin medications, such as ezetimibe, which have not been shown to improve any clinical outcomes.”

Downs and Good also praised the shift away from target goals. “A fixed-dose strategy should remove the impetus for unwieldy lipid-lowering combinations, which expose patients to unnecessary harm and expense.”

The editorialists called for a shared decision-making approach for dosage.

“Higher-intensity statins are not as well-tolerated and are not associated with overall mortality benefit compared with moderate-dose statins,” they wrote. “Perhaps a more patient-centered strategy would be to start with moderate-dose statins in most patients and use a shared-decision approach to increase to a high dose as tolerated.”

Read evidence, not drama

Eliseo Guallar, MD, DrPH, and Christine Laine, MD, MPH, encouraged clinicians to focus on the evidence presented in the guidelines and not the surrounding controversy.

To quell controversies in the future, guideline developers should include more stakeholders during development, make recommendations available for scrutiny before a guideline is finalized, make available clear and comprehensive educational materials when a new guideline counters prior practice, and stop making releases of new guidelines into media events, Guallar, of the Johns Hopkins Bloomberg School of Public Health, and Laine, editor of Annals of Internal Medicine, wrote.

“Criticism of the ACC/AHA recommendations may have been mitigated had the report describing the risk model used to identify eligibility for cholesterol treatment been available for public scrutiny before the guideline was released,” they wrote.

Accompanying the editorials is a synopsis of the new guidelines written by Neil J. Stone, MD, of Northwestern University Feinberg School of Medicine, and other members of the ACC/AHA Cholesterol Guideline Panel.

For more information:

Downs J. Ann Intern Med. 2014;doi:10.7326/M13-2850.

Guallar E. Ann Intern Med. 2014;doi:10.7326/M14-0112.

Martin SS. Ann Intern Med. 2014;doi:10.7326/M13-2805.

Stone NJ. Ann Intern Med. 2014;doi:10.7326/M14-0126.

Disclosure: See the full editorials for a list of the authors’ relevant financial disclosures.