ACC/AHA Lipid Guidelines: A Step up in Diabetes Care, or Not?

Marlene Busko

June 14, 2014

SAN FRANCISCO — Clinicians don't need LDL-cholesterol "goals" when treating diabetic patients at high risk for cardiovascular disease, because strong evidence to support specific targets doesn't exist and clinicians should be using "common sense" and the new risk calculator.

So says Robert H. Eckel, MD, of the University of Colorado, Denver, defending the reasoning behind the recent new lipid guidelines jointly developed by American College of Cardiology (ACC) and the American Heart Association (AHA). He explained here at the American Diabetes Association (ADA) 2014 Scientific Sessions why they are appropriate for patients with diabetes.

But debate adversary Henry Ginsberg, MD, from Columbia University, New York, who wrote a widely read critique on the issue that was published in Circulation Research (Circ Res. 2014;114:761-764), disagrees, saying the new lipid guidelines do not provide appropriate direction for treating diabetic patients, because they try to make things too simple.

The 2 squared off at a press briefing here on Friday and spoke to Medscape Medical News about their opinions ahead of the official debate on June 17.

While they generally agree that just about everybody with diabetes should be on a statin, their opinions diverge when it comes to going beyond statins when required, they explained.

Diabetic Patients Are 1 of 4 "At-Risk" Groups

The ACC/AHA standards of care for the management of lipids were issued at the end of 2013 and were seen as a radical departure from previous iterations, most notably for their abandonment of LDL targets.

Press conference moderator, Robert E. Ratner, MD, chief scientific and medical officer of the American Diabetes Association, explained that the release date meant it was too late for the guidelines to be incorporated into the ADA standards of care, published in January 2014 in Diabetes Care.

Dr. Eckel, who was part of the new lipids guideline committee, presented his case for the "pro" side, beginning by explaining that the committee stringently followed the mandate from the Institute of Medicine to base their recommendations on solid evidence, meaning randomized controlled trials.

The committee identified four "at-risk" groups, one of which was patients with diabetes who are aged 40 to 75 and have LDL-cholesterol levels between 70 and 189 mg/dL.

As previously reported, the guidelines recommend that if diabetic patients fitting these criteria have no evidence of atherosclerotic cardiovascular disease, they should receive a moderate-intensity statin, but if their 10-year risk of atherosclerotic cardiovascular disease exceeds 7.5% (based on a new risk calculator), a high-intensity statin is a reasonable choice.

"Targets Are Not Wrong, Just Not Evidence-Based"

"[The LDL-cholesterol] targets are not wrong, they're just not evidence based," Dr. Eckel said.

Even though clinical trials were not designed to evaluate treatment targets, that doesn't preclude clinicians from setting goals for a patient's lipid levels.

"In my own practice I set goals for LDL and non-HDL cholesterol in some patients, fully realizing that I'm going beyond the guidelines," he told Medscape Medical News. "I think the guidelines are meant to inform, not to mandate."

To this end, the guideline committee occasionally used "expert opinion," he noted. For example, "we felt that in patients with diabetes, there were times in which a moderate dosage [of a statin] may not be enough. Moreover, we did not preclude the use of other lipid-lowering drugs like fibrates, ezetimibe [Zetia, Merck/Schering-Plough], bile-acid sequestrants, or niacin," although the evidence was insufficient at this time to issue any firm recommendations on these agents, he added.

Dr. Eckel said the new risk calculator can be used to guide treatment of typical patients seen in clinical practice.

For example, to lower cardiovascular disease risk in a 35-year-old woman who has had type 1 diabetes for 30 years, "I think most people would say she needs to be on a statin, [with] special steps [to discontinue it] while she's conceiving, pregnant, or nursing," he said.

While for an 80-year-old man with type 2 diabetes, "I think the guidelines adequately address the relative risk/benefit ratio; we just don't have enough clinical trials in 80- and 85-year-olds to say 'this is what you should do.' "

Lower LDL Is Better Than Higher; Guidelines Fall Short for Diabetes

Dr. Ginsberg told journalists here that while he applauds the new recommendations to treat people based on their risk profiles, the flip side is that "the tyranny of randomized controlled trials" produced a document that falls short, particularly for patients with diabetes.

"I don't think Dr. Eckel and I…have any disagreement over the fact that just about everybody with diabetes should be on a statin," Dr. Ginsberg told Medscape Medical News.

However, "studies like TNT and PROVE-IT and other trials where they looked at statins of varying intensity clearly indicate that a lower LDL is better than a higher LDL," he observed. "So I do think that they've left the doctor with a sense of 'just put the patient on a statin and that's all you need to do,' and I don't think the evidence supports that.

"Where I have my largest issue is in not going beyond statins when needed," Dr. Ginsberg told the media briefing.

There is no clinical-trial evidence showing that in diabetic patients at high risk for CVD adding a nonstatin drug is more beneficial than a statin alone, "but we do have evidence that a lower LDL is better than a higher LDL and a greater degree of lowering is better than a moderate degree of lowering," he pointed out.

And analyses of trial subgroups have shown benefits of high-dose statins in diabetic patients who have had a previous cardiovascular event. "The difference between a moderate- and a high-intensity statin is pretty modest anyway, so why not push the statin to as high a dose as you can?" he asked.

"Throughout the [ACC/AHA lipid guideline] text it says, for the individual patient and the individual doctor, they should make the best decision, but that's sort of like pablum," Dr Ginsberg said.

Eckel is on the advisory panel of Janssen Pharmaceuticals. He is a consultant for Amarin, Amgen, Esperion, and Genfit, and he receives research support from Esperion. Ginsberg is on the advisory panel for Merck, Regeneron Pharmaceuticals, and Sanofi. He is a consultant for Amarin, AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Bristol-Myers Squibb, Genentech, Genzyme, ISIS Pharmaceuticals, Janssen Pharmaceuticals, Kowa Research Institute, Novartis, and Pfizer. He receives research support from Genzyme, Merck, Regeneron Pharmaceuticals, and Sanofi.

American Diabetes Association 2014 Scientific Sessions; June 17, 2014. Debate

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