ADA Endorses ACC/AHA Statin Guidelines, With Caveats

Miriam E Tucker

December 24, 2014

The American Diabetes Association has revised its guidelines for use of statins in people with diabetes to align with those issued in 2013 by the American College of Cardiology and the American Heart Association.

The change was included in the ADA's 2015 update of the Standards of Medical Care in Diabetes, published every January as a supplement to Diabetes Care. Like the still-controversial ACC/AHA guidelines, the new ADA recommendation focuses on statin use by risk profile rather than LDL-cholesterol measurement. Because diabetes itself is a major risk factor for cardiovascular disease, the ADA recommends statin use for nearly everyone with diabetes and provides further guidance on starting doses.

However, the ADA does not strongly endorse the also-controversial ACC/AHA "risk calculator" and does advise measuring LDL as needed to monitor adherence. The new ADA statement also acknowledges major evidence gaps with regard to lipid lowering, such as for patients younger than 40 or older than 75 years and those with type 1 diabetes.

"We changed pretty substantially our recommendations from the prior year. We basically more or less adopted what ACC/AHA said, with caveats," ADA professional practice committee chair Richard W Grant, MD, a research scientist at Kaiser Permanente, Oakland, California and the University of California, San Francisco, told Medscape Medical News.

In addition to the new statin guidelines, other 2015 revisions to the ADA Standards include a change in the body mass index (BMI) cut point for screening Asian Americans for prediabetes and diabetes, new targets for diastolic blood pressure and for the low end of the glycemic range, a new recommendation for combating sedentary time, and a stance against e-cigarettes. The format of the Standards itself is also new this year, released as a single document rather than separate position statements.

"Substantial" Change in Statin Guidance

Dr Grant told Medscape Medical News that of all the 2015 revisions, the new statin recommendation was the most difficult for ADA's 14 practice-committee members. "That's the thing we struggled with the longest and the most. We've always checked LDL levels and, on the basis of LDL-cholesterol levels, started and adjusted the dose of statins to get under a certain level….That's been tattooed in every doctor's brain for the past 15 years or so."

We've always checked LDL levels....That's been tattooed in every doctor's brain for the past 15 years.

Now, the ADA guidelines divide diabetes patients by three age groups:

  • Less than 40 years — No statins for those with no CVD risk factors other than diabetes, moderate-intensity or high-intensity statin doses for those with additional CVD risk factors (baseline LDL cholesterol 100 or greater, high blood pressure, smoking, and overweight/obesity), and high-intensity statin doses for those with overt CVD (including previous CV events or acute coronary syndrome).

  • 40 to 75 years — Moderate-intensity statins for those with no additional risk factors and high-intensity statins for those with either CVD risk factors or overt CVD.

  • Over 75 years — Moderate-intensity statins for those with no additional risk factors, moderate- or high-intensity statins for those with CVD risk factors and high-intensity for those with overt CVD.

Lipid monitoring for adherence is recommended as needed, and annual monitoring is advised for patients younger than 40 years who have not yet started statins.

Dr Grant said that among the panel members there was "a strong feeling that you can't give up testing LDL, for a lot of reasons. It helps to know whether the patient is responding and if they're taking their meds. It also helps the patient to know that their LDL has come down….But it's not like the old days where you treated based on LDL."

As for the risk calculator, the ADA document notes that while it "may be a useful tool to estimate 10-year atherosclerotic CVD," it "has limited use for assessing risk in people with diabetes."

"Our perspective was that in the real world very few doctors and patients have time to sit down and enter data into a risk calculator.…It just doesn't translate that well into usual care in busy practices.…Also, there's a question raised about how well it works in patients with diabetes," Dr Grant noted.

Other Changes for 2015

Several other revisions this year were made as a result of new data or refinements to previous recommendations. They include:

•   A new BMI cut point of 23 kg/m2 (instead of 25 kg/m2) for screening Asian Americans for prediabetes and diabetes, based on evidence that Asian populations are at increased risk at lower BMIs relative to the general population.

•   The premeal glucose targets of 70 to 130 mg/dL was changed to 80 to 130 to better reflect new data that compared average glucose levels with HbA1c targets.

•   The goal for diastolic blood pressure was raised to 90 mm Hg from 80 mm Hg to better reflect data from randomized clinical trials. "The A-level evidence is based on 90….It's not saying that getting down to 80 is a bad thing, but the evidence isn't as strong," Dr Grant said. (This follows ADA's 2013 shift from a systolic target of 130 mm Hg to 140 mm Hg.)

•   With regard to physical activity, the document now advises limiting the time spent sitting to no longer than 90 minutes. "[The exercise recommendation] was always by number of minutes per week. Now we're saying that even with the same minutes, better to break up the time. It's not enough to go for a walk after work; you have to get up and walk during work," Dr Grant explained.

•   In a new statement, the ADA states that it does not support e-cigarettes as alternatives to smoking or to facilitate smoking cessation.

•   Immunization against pneumococcal disease was added as a recommendation.

•   A new HbA1c target of less than 7.5% for children, first released in June 2014, is now included in the 2015 standards.

•   A new section on management of diabetes in pregnancy has been added, consolidating information that had been spread in different parts of previous documents.

•   The document itself has been streamlined, so that the Standards of Medical Care in Diabetes is its title and 14 sections are included within it. Previously, the overall document had been called "Clinical Practice Recommendations," and the "Standards" were just part of it, along with separate position statements.

Most Evidence-Based Recommendations Yet

When making guidelines you have to account for every patient....In medicine, you do the best you can.

Dr Grant told Medscape Medical News that there will be an article published along with the new document that summarizes an ADA analysis of trends in the Standards over the past 10 years, finding that the 2014 edition was the first in which more than 50% of the guidelines were based on evidence that was either level A (from adequately powered well-controlled randomized trials) or level B (from well-controlled cohort or case-control studies).

""We continue to strive to have more and more evidence-based recommendations," he said.

But he also pointed out that with diabetes in particular, not everything can be based on top-level evidence. "In diabetes, everything we do is multifactorial…no studies look at all these things at once."

And, he noted, plenty of diabetes patients don't resemble those who participate in randomized clinical trials. "When making guidelines you have to account for every patient, so a lot of the fill-in is with E (expert opinion) level.…In medicine, you do the best you can."

The ADA funds development of the Standards of Care and all ADA position statements out of its general revenues and does not use industry support for those purposes. Dr Grant has no disclosures.

Diabetes Care. Published online December 23, 2014. Available at: http://care.diabetesjournals.org.

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