New Cholesterol Guidelines: "Listen to the Evidence, Not the Noise"

By Megan Brooks

NEW YORK (Reuters Health) - Publication late last year of updated guidelines on cardiovascular risk assessment and cholesterol treatment generated considerable controversy among doctors, and media attention.

A series of papers published online today in Annals of Internal Medicine seek to help doctors make sense of the new guidelines amidst the controversy. The series includes a concise synopsis of the guidelines for clinicians.

In an editorial, Dr. Eliseo Guallar of Johns Hopkins Bloomberg School of Public Health in Baltimore and Dr. Christine Laine, Editor in Chief of Annals of Internal Medicine, urge doctors to "listen to the evidence, not the noise" the guidelines generated initially.

A Paradigm Shift

The new guidelines, a joint effort by an expert panel of the American College of Cardiology and American Heart Association, differ significantly from any prior guidelines, note the authors of an Ideas and Opinions article.

They are narrower in scope, focused more on randomized control trial (RCT) evidence than expert opinion, more closely follow the Institute of Medicine guideline tenets, and are more transparent with conflicts of interest, according to Dr. John Downs from South Texas Veterans Health Care System in San Antonio and Dr. Chester Good from University of Pittsburgh.

"Several of the recommendations from the expert panel truly represent a paradigm shift with tremendous implications," they say. They "applaud the panel for the courage to make these changes."

One major change in the guidelines is the recommendation that doctors abandon the "treat to target" paradigm for lipid levels in favor of a "fixed-dose" statin approach. They recommend lipid measurement at baseline, one to three months after statin initiation, and then annually to check for the expected percentage decrease of LDL cholesterol levels (30% to 45% with a moderate-intensity statin and at least 50% with a high-intensity statin).

This "makes sense for many reasons," Downs and Good say. First, a strategy using fixed dose statins is consistent with RCTs, as opposed to a focus on LDL-C targets which was never supported by RCT evidence. "As such, this evidence-based approach greatly simplifies treatment for clinicians, and is clearly more patient-centered," they write. "Fewer dose adjustments and fewer labs should be a welcome change for patients and primary care providers," they add.

In addition, a fixed dose strategy should "remove the impetus for unwieldy lipid lowering combinations, which expose patients to unnecessary harm and expense. Finally, some high-risk patients who met LDL-C goals with no statin or low dose statin could benefit from a more evidence-based fixed dose statin strategy," Downs and Good say.

Concepts to "Rally Behind"

A more controversial aspect of the new guidelines is the adoption of a new calculator for 10-year risk for myocardial infarction or stroke, which may overestimate the risk of atherosclerotic cardiovascular disease considerably, according to some calculations, and a lowering of statin treatment thresholds to 10-year risk equal to or greater than 7.5%. "We hope that the planned 2014 update will include improvement to the risk calculator," Downs and Good say.

In a separate Ideas and Opinions piece, Dr. Seth Martin and Dr. Roger Blumenthal of Johns Hopkins Hospital, Baltimore, Maryland say that despite the controversy, the new risk assessment and cholesterol treatment guidelines "emphasize important core concepts to rally behind. A patient's risk estimate is now the number to know rather than his or her LDL-C level, unless the LDL-C level is 190 mg/dL or greater."

"I think now that people have had time to digest the guidelines, they are realizing that the guidelines are meant to have a fair bit of flexibility and view it as a significant step forward," Dr. Blumenthal said in an interview with Reuters Health.

He and his co-author note in their article that the new guidelines "value the art of medicine in that they allow room for individualizing primary prevention on the basis of shared decision making between the patient and clinician. Encouraging greater patient-provider dialogue is a virtue of the new guidelines but finding time for these discussions will be challenging."

"One thing that didn't come through when the guidelines were first released is that doctors and patients should have a risk discussion, really on anyone who has greater than a 5% risk of heart attack or stroke over the next 10 years," Dr. Blumenthal told Reuters Health.

A Perfect Storm

In their editorial Dr. Guallar and Dr. Laine say the new cholesterol guidelines "landed in a perfect storm created by the release of the documents a few days before a high-profile meeting and media stories that sensationalized disagreements among stakeholders."

"The mudslinging outcry that increasingly seems to accompany guidelines is damaging, creates the impression that health care professionals are clueless, and risks compromising evidence-based medicine," they write.

What's the solution? "To start," including multiple stakeholders during guideline development could limit post-release criticism, they say. Also, guideline developers "should aim to base their recommendations on formal evidence reviews that are subject to rigorous peer review and fully available for scrutiny before a guideline is finalized."

When guidelines run counter to prior practice, "educational materials clearly explaining the evidence supporting the changes should be made available to clinicians, patients, and the public," they advise.

"Finally, professional organizations should refrain from turning the release of new or updated guidelines into media events, and the media should refrain from turning the scientific debate that surrounds guidelines into stories of professional strife and disregard for patients. If the goal is high-value health care for all, we must quiet the noise that accompanies guidelines so that we can hear the evidence speak."

"I am not privy to the internal discussion at the American Heart Association and the American College of Cardiology generated as a result of the controversy and confusion generated by the recent guidelines, but I would be very surprised if these organizations do not reconsider their guideline development and release processes carefully," Dr. Guallar told Reuters Health by email.

"We will need studies," she added, "to understand guideline uptake and compliance with these guidelines and how they compare with previous guidelines in this area and with guidelines in other specialties. Unfortunately, my impression is that the controversy and confusion generated over these guidelines will negatively affect physician uptake of the guidelines and patient compliance."

SOURCES: http://bit.ly/1aYOeML, http://bit.ly/1f43Ijt, http://bit.ly/1jCghqg and http://bit.ly/L43xJZ

Ann Intern Med 2014.

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