On March 6, the American College of Physicians (ACP) published new evidence-based guidance statements in Annals of Internal Medicine(annals.org) that focus on loosening glycemic control targets.
The ACP recommended patients with type 2 diabetes be treated to achieve a hemoglobin A1c (HbA1c) level between 7 percent and 8 percent rather than the widely accepted range of 6.5 percent to 7 percent.
"ACP's analysis of the evidence behind existing guidelines found that treatment with drugs to targets of 7 percent or less compared to targets of about 8 percent did not reduce deaths or macrovascular complications such as heart attack or stroke but did result in substantial harms," said ACP President Jack Ende, M.D., in a news release.(www.acponline.org)
"The evidence shows that for most people with type 2 diabetes, achieving an A1c between 7 percent and 8 percent will best balance long-term benefits with harms such as low blood sugar, medication burden and costs."
- On March 6, the American College of Physicians (ACP) published new evidence-based guidance statements in Annals of Internal Medicine on loosening glycemic control targets.
- The ACP recommended patients with type 2 diabetes be treated to achieve a hemoglobin A1c between 7 percent and 8 percent rather than the widely accepted range of 6.5 percent to 7 percent.
- The ACP also released three other guidance statements on selecting targets for pharmacologic treatment of type 2 diabetes.
Noting the policy implications of its recommendations, the ACP suggested that any physician performance measures developed to evaluate quality of care should not have a target HbA1c level below 8 percent for any patient population and should not have any HbA1c targets for elderly adults (i.e., those 80 and older) or younger individuals with limited life expectancy because of other serious diseases or illnesses.
According to Jennifer Frost, M.D., medical director for the AAFP Health of the Public and Science Division, the Academy has endorsed a 2016 ACP clinical practice guideline on oral pharmacologic treatment of type 2 diabetes mellitus(annals.org) that emphasized "individualized assessment of risk for complications from diabetes, comorbidity, life expectancy and patient preferences."
That guideline said, "An HbA1c level less than 7 percent based on individualized assessment is a reasonable goal for many but not all patients."
"The AAFP strongly supports individualized treatment and shared decision-making based on a balance of potential benefits and harms," Frost told AAFP News. "Rather than targeting a specific number, family physicians should consider patients' goals and preferences along with their comorbidities. Treatment of diabetes, or any chronic illness, is not 'one size fits all.'"
It also should be noted that representatives from the American Diabetes Association (ADA) and American Association of Clinical Endocrinologists (AACE) have said they do not agree(www.npr.org) with the higher glycemic control targets outlined in the newly released ACP guidance statements.
The ACP released the following four guidance statements on selecting appropriate targets for pharmacologic treatment of type 2 diabetes:
Guidance Statement 1: Clinicians should personalize goals for glycemic control in patients with type 2 diabetes based on a discussion of benefits and harms of pharmacotherapy, patients' preferences, patients' general health and life expectancy, treatment burden, and costs of care.
Guidance Statement 2: Clinicians should aim to achieve an HbA1c level between 7 percent and 8 percent in most patients with type 2 diabetes.
Guidance Statement 3: Clinicians should consider deintensifying pharmacologic therapy in patients with type 2 diabetes who achieve HbA1c levels less than 6.5 percent.
Guidance Statement 4: Clinicians should treat patients with type 2 diabetes to minimize symptoms related to hyperglycemia and avoid targeting an HbA1c level in patients with a life expectancy less than 10 years due to advanced age (80 or older), residence in a nursing home or chronic conditions (such as dementia, cancer, end-stage kidney disease or severe chronic obstructive pulmonary disease or congestive heart failure) because the harms outweigh the benefits in this population.
The ACP explained that its guidance statements were based on a review and methodological critique of existing and sometimes conflicting guidelines rather than a systematic review of all available evidence.
The group reviewed and rated six guidelines, focusing specifically on sections that addressed HbA1c in nonpregnant patients with type 2 diabetes. They included four commonly used guidelines from the AACE and American College of Endocrinology, the ADA, the Scottish Intercollegiate Guidelines Network, and the U.S. Department of Veterans Affairs and Department of Defense. The AGREE II (Appraisal of Guidelines for Research and Evaluation II) instrument was used to evaluate the guidelines.
In performing that review, the ACP found five large, long-term randomized controlled trials that investigated intensive (achieved HbA1c levels of 6.3 percent to 7.4 percent) versus less intensive (achieved HbA1c levels of 7.3 percent to 8.4 percent) treatment target strategies in adults, with average baseline ages between 53 and 66.
"They found that the main effect of more intensive glycemic control is small absolute reductions in risk for microvascular surrogate events, such as retinopathy detected on ophthalmologic screening or nephropathy defined by development or progression of albuminuria," the guideline said.
Studies haven't consistently shown, however, that intensive glycemic control to HbA1c levels below 7 percent reduced clinical microvascular events -- such as loss or impairment of vision, end-stage renal disease, or painful neuropathy -- or reduced macrovascular events and death.
"No trials show that targeting HbA1c levels below 6.5 percent in diabetic patients improves clinical outcomes, and pharmacologic treatment to below this target has substantial harms," the statement said.
For example, the ACCORD trial, which targeted an HbA1c level less than 6.5 percent and achieved the lowest level of the included studies (6.4 percent), was discontinued early because of increased overall and cardiovascular-related death and severe hypoglycemic events.
"Results from studies included in all the guidelines demonstrate that health outcomes are not improved by treating to A1c levels below 6.5 percent," Ende said in the news release. "However, reducing drug interventions for patients with A1c levels persistently below 6.5 percent will reduce unnecessary medication harms, burdens and costs without negatively impacting the risk of death, heart attacks, strokes, kidney failure, amputations, visual impairment or painful neuropathy."
Family Physician Expert's Perspective
John Boltri, M.D., of Rootstown, Ohio, represents the AAFP on the NIH's National Diabetes Education Program. He told AAFP News that family physicians should use a patient-centered approach with patients who have type 2 diabetes when discussing the risks and benefits of HbA1c at different target levels.
Until now, said Boltri, most family physicians usually have set a target HbA1c at 7 percent, unless patients are older and their life expectancy is shorter. The new ACP guidance statements might allow family physicians to relax their goals, especially in patients for whom achieving 7 percent isn't a reasonable goal, he noted.
"If a patient with type 2 diabetes' A1c is starting out at 8 or 7.5 percent, less than 7 percent might be a good target," Boltri explained. "If A1c is starting at 13 percent, getting to less than 7 percent is probably unreasonable; shooting for 7 percent to 8 percent is probably a lot more reasonable in those patients."
Practicing family physicians also should consider factors such as patients' goals, life expectancy and ability to tolerate medications in these discussions, Boltri said.
It's also important to remember that there are many other factors that lead to morbidity in patients with diabetes, such as cardiovascular disease, being sedentary, hyperlipidemia and obesity, he added.
"So, a singular focus on a hemoglobin A1c without looking at the big picture is less beneficial to patients," Boltri stated.
As for the guidance statement on deintensifying pharmacologic therapy if patients have HbA1c levels below 6.5 percent, Boltri agreed that aggressive control to less than 6.5 percent may increase mortality, and consideration should be given to mitigating those risks.
However, he added, "If I have a patient at 7.1 percent and they can get down to 6.4 percent with diet and lifestyle changes alone, I'm not going to back off on their treatment plan. So, this shouldn't be a universal 'We have them at 6.3 percent, so we need to get them back up to 7 percent.'
"On the other hand, if you're having to use three drugs to get them to 6.3 percent and they are experiencing adverse effects, it might be safer for your patient to back off therapy."
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