Guidelines

ADA’s revised diabetes 'standards' broaden statin use

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Statin treatment benefits most diabetes patients

The efficacy of a moderate statin dosage for primary prevention of cardiovascular disease events in patients age 40-75 years with type 2 diabetes and no other risk factors was clearly established a decade ago by results from the Collaborative Atorvastatin Diabetes Study (CARDS) (Lancet 2004;364:685-96).

No prospective, randomized study has proved the efficacy of statin treatment in patients younger than 40 years with diabetes and no other risk factors; but we see increasing numbers of these patients, and they, too, are at high risk for cardiovascular disease events. I agree with the 2013 recommendation from the American College of Cardiology and American Heart Association that statin treatment should be discussed and in many cases started for these younger, lower-risk patients who still face an important cardiovascular disease risk from their diabetes alone.

Changing the target diastolic blood pressure to less than 90 mm Hg is also consistent with existing evidence. A few years ago, I wrote in an editorial that some prior blood pressure targets for patients with diabetes had been set too low (Circulation 2011;123:2776-8).

There is no evidence that patients with diabetes will benefit from a diastolic blood pressure target that is lower than less than 90 mm Hg, and an overly aggressive approach to blood pressure reduction potentially can cause adverse events. Elderly patients with diabetes often have “silent” coronary artery disease, and if their diastolic pressure goes too low, they can have inadequate coronary perfusion that will cause coronary ischemia.

Dr. Prakash Deedwania

But the diastolic blood pressure target also needs individualization. Some patients, such as those with Asian ethnicity, may benefit from the greater stroke reduction achieved with more aggressive blood pressure reduction.

Aspirin use in patients with diabetes and no other cardiovascular disease risk factors has been controversial, but recent evidence from the Japanese Primary Prevention Project suggests it does not benefit patients with diabetes, even if they may also have hypertension, dyslipidemia, or both. About a third of the patients aged 60-85 years enrolled in this Japanese study had diabetes, more than 70% had dyslipidemia, and 85% had hypertension. But despite this background, daily low-dose aspirin did not reduce the incidence of atherosclerotic cardiovascular disease events during 5 years of follow-up of more than 14,000 randomized patients (JAMA 2014;312:2510-20).

Dr. Prakash C. Deedwania is professor of medicine at the University of California, San Francisco, and director of cardiology at the VA Central California Health Care System in Fresno. He made these comments in an interview. He has served as a consultant to several drug companies that market statins.


 

FROM DIABETES CARE

References

Most patients with diabetes should receive at least a moderate statin dosage regardless of their cardiovascular disease risk profile, according to the American Diabetes Association’s annual update to standards for managing patients with diabetes.

“Standards of Medical Care in Diabetes–2015” also shifts the ADA’s official recommendation on assessing patients for statin treatment from a decision based on blood levels of low density lipoprotein (LDL) cholesterol to a risk-based assessment. That change brings the ADA’s position in line with the approach advocated in late 2013 by guidelines from the American College of Cardiology (ACC) and the American Heart Association (AHA) (J. Am. Coll. Cardiol. 2014;63:2889-934).

The ADA released the revised standards online Dec. 23.

The statin use recommendation is “a major change, a fairly big change in how we provide care, although not that big a change in what most patients are prescribed,” said Dr. Richard W. Grant, a primary care physician and researcher at Kaiser Permanente Northern California in Oakland and chair of the ADA’s Professional Practice Committee, the 14-member panel that produced the revised standards.

Dr. Richard W. Grant

Dr. Richard W. Grant

“We agreed [with the 2013 ACC and AHA lipid guidelines] that the decision to start a statin should be based on a patient’s cardiovascular disease risk, and it turns out that nearly every patient with type 2 diabetes should be on a statin,” Dr. Grant said in an interview.

The revised standards recommend a “moderate” statin dosage for patients with diabetes who are aged 40-75 years, as well as those who are older than 75 years even if they have no other cardiovascular disease risk factors (Diabetes Care 2015;38:S1-S94).

The dosage should be intensified to “high” for patients with diagnosed cardiovascular disease, and for patients aged 40-75 years with other cardiovascular disease risk factors. For patients older than 75 years with cardiovascular disease risk factors, the new revision calls for either a moderate or high dosage.

However, for patients younger than 40 years with no cardiovascular disease or risk factors, the revised standards call for no statin treatment, a moderate or high dosage for patients younger than 40 years with risk factors, and a high dosage for those with cardiovascular disease.

The ADA’s recommendation for no statin treatment of the youngest and lowest-risk patients with diabetes is somewhat at odds with the 2013 ACC and AHA recommendations. For this patient group, those recommendations said, “statin therapy should be individualized on the basis of considerations of atherosclerotic cardiovascular disease risk-reduction benefits, the potential for adverse effects and drug-drug interactions, and patient preferences.”

The new standards revision contains several other changes, including:

• The recommended goal diastolic blood pressure for patients with diabetes was revised to less than 90 mm Hg, an increase from the 80–mm Hg target that had been in place. That change follows a revision in the ADA’s 2014 standards that increased the systolic blood pressure target to less than 140 mm Hg.

Changing the diastolic target to less than 90 mm Hg was primarily a matter of following the best evidence that exists in the literature, Dr. Grant said, because only lower-grade evidence supports a target of less than 80 mm Hg.

The revised standards also note that the new targets of less than 140/90 mm Hg put the standards “ in harmonization” with the 2014 recommendations of the panel originally assembled at the Eighth Joint National Committee (JAMA 2014;311:507-20).

• The recommended blood glucose target when measured before eating is now 80-130 mg/dL, with the lower limit increased from 70 mg/dL. That change reflects new data that correlate blood glucose levels with blood levels of hemoglobin A1c.

• The revision sets the body mass index cutpoint for screening overweight or obese Asian Americans at 23 kg/m2, an increase from the prior cutpoint of 25 kg/m2.

• A new section devoted to managing patients with diabetes during pregnancy draws together information that previously had been scattered throughout the standards document, Dr. Grant explained. The section discusses gestational diabetes management, as well as managing women who had preexisting type 1 or type 2 diabetes prior to becoming pregnant.

Dr. Grant had no disclosures.

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

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