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ACP recommends less intensive glycemic control targets for type 2 diabetes
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In an evidence-based guidance statement, the ACP advised that patients with type 2 diabetes be treated to reach HbA1c levels between 7% and 8%, instead of between 6.5% and 7%.
“Diabetes mellitus is a leading cause of death in the United States and is associated with microvascular and macrovascular complications,” Amir Qaseem, MD, PhD, MHA, from the ACP, and colleagues wrote.
“Over time, the metabolic derangements associated with diabetes may lead to vision loss, painful neuropathy or sensory loss, foot ulcers, amputations, myocardial infarctions, strokes, and end-stage renal disease,” they added. “Lowering blood glucose may decrease risk for complications, but lowering strategies come with harms, patient burden and costs.”
The guideline, published in Annals of Internal Medicine, is based on a review of several national guidelines on HbA1c targets for glycemic control in nonpregnant adults with type 2 diabetes.
Authors reviewed guidelines from the NIH, Care Excellence and the Institute for Clinical Systems Improvement, American Association of Clinical Endocrinologists and American College of Endocrinology, the American Diabetes Association, the Scottish Intercollegiate Guidelines Network, and the U.S. Department of Veterans Affairs and Department of Defense.
After their review, the ACP recommended that physicians discuss the benefits and harms of pharmacotherapy, preferences, general health and life expectancy, treatment burden and costs of care with patients who have type 2 diabetes, then personalize their goals for glycemic control. ACP advised that achieving an HbA1c level between 7% and 8% is ideal for most patients with type 2 diabetes.
When treating patients with type 2 diabetes who attain HbA1c levels lower than 6.5%, physicians should reduce pharmacologic therapy by decreasing the dosage, discontinue drug treatment or remove a drug if multiple medications are being taken, according to ACP.
“Results from studies included in all the guidelines demonstrate that health outcomes are not improved by treating to [HbA1c] levels below 6.5%,” Jack Ende, MD, president of ACP, said in a press release. “However, reducing drug interventions for patients with [HbA1c] levels persistently below 6.5% 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.”
In the guideline, ACP also recommended that the primary goal when treating a patient with type 2 diabetes is to reduce hyperglycemia-related symptoms. The risk of harm exceeds the benefits of targeting a specific HbA1c level in patients with type 2 diabetes who are 80 years or older and have a life expectancy of less than 10 years, those residing in a nursing home and those with chronic conditions, including dementia, cancer, end-stage kidney disease, severe COPD or congestive heart failure; therefore, physicians should focus on reducing symptoms rather than a specific HbA1c goal, according to ACP.
“Although ACP’s guidance statement focuses on drug therapy to control blood sugar, a lower treatment target is appropriate if it can be achieved with diet and lifestyle modifications such as exercise, dietary changes and weight loss,” Ende said.
‘More harm than good’
The ACP guidance statement has prompted concern from endocrinology organizations. In a joint statement released March 9, the Endocrine Society, the ADA and AACE voiced strong disagreement with the higher blood glucose targets.
“The ACP’s recommendation of blood glucose targets for HbA1c from 7% to 8% could prevent many patients from receiving the full benefits of long-term glucose control,” the organizations said in the joint statement. “We are also concerned the broad range suggested by ACP’s guidance is too large to apply to most patients with type 2 diabetes and has the potential to do more harm than good for many patients for whom lower blood glucose targets may be more appropriate, particularly given the increased risk of serious complications, such as cardiovascular disease, retinopathy, amputation and kidney disease, which are the result of higher blood glucose levels.”
The three organizations went on to note that the additional percentage point in HbA1c level in the ACP guideline may equate to a difference of “nearly 30 points” when measured in milligrams per deciliter, adding that the recommendations do not consider the positive legacy effects of intensive blood glucose control confirmed in multiple clinical trials, particularly for those with newly confirmed type 2 diabetes.
“ACP’s guidance also does not consider the positive impact of several newer medication classes (SGLT2 inhibitors and GLP-1 receptor agonists) demonstrated in more recent clinical trials to improve mortality and morbidity in high-risk patients with type 2 diabetes,” the statement said. “These medications have been associated with low risk for hypoglycemia, have favorable effects on weight and demonstrate improved cardiovascular disease outcomes.”
In a related press release, David W. Lam, MD, assistant professor of medicine in the division of endocrinology, diabetes and bone diseases at the Icahn School of Medicine at Mount Sinai, said that this guidance statement emphasizes the importance of a patient centered approach when caring for those with type 2 diabetes and the importance of balancing specific HbA1c targets with the impact of treatment.
“I wholeheartedly agree with this approach; providers should focus their care on the individual patient and consider all aspects of the patient’s health and well-being,” he added. “While the vast majority of providers do this already, it is an important reminder of the impact our treatment has on aspects such as disease burden, quality of life, cost of health care, and adverse effects from medications.”
“For the ‘every day provider,’ besides adverse effects of medications, the other aspects can sometimes be difficult to quickly quantify and measure,” he continued. “Empowering providers with tools that can quickly assess disease burden and quality of life, in any clinical setting, and adding more transparency in the cost of medications to patients would be essential to integrate these aspects into clinical decision making.” – by Alaina Tedesco
Disclosure: Ende, Qaseem and Lam report no relevant financial disclosures. Please see study for all other authors’ relevant financial disclosures.
Perspective
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Jack Ende, MD
The ACP approaches the guideline process and the guidance statement process with great care. We do very thorough literature reviews and base our recommendations on evidence. The College can stand by its recommendations because they are evidence-based. In this case, we looked at the results of six guidelines and five clinical trials and focused not so much on what we think is going on, but what does the evidence show. That led to the conclusions presented in our four guidance statements.
There are harms associated with more rigorous blood sugar targets. Two studies show exactly that. The first is the ACCORD study which showed that patients treated intensively, to a target of 6.5% demonstrated an increase in all-cause mortality, as well as an increase in cardiovascular mortality and an increase in clinically important hypoglycemic events. The ADVANCE study found more hypoglycemia and more hospitalizations in the intensely treated group. Neither study showed important clinical benefit.
When we look for clinical benefit for the care of diabetes, we look for fewer patients having to undergo amputation of limbs, fewer patients losing their vision or going into renal failure. There were no significant benefits associated with the more intense treatment.
Clinicians are becoming, and certainly need to become, careful consumers of guideline recommendations. They need to look at how well the data were systematically collected and analyzed. They have to look to be sure there is no bias, that is, are the people who are producing the guidelines influenced by preconceived notions about what these guidelines should look like.
There are rigorous grading systems for guidelines, such as the AGREE II ratings of guidelines used in our paper. Not all guidelines are the same, in terms of stakeholder involvement, rigor, clarity, applicability and editorial independence. Physicians who take care of patients need to be sophisticated consumers of the recommendations that are put before them.
There is never any substitute for individualizing care of patients. Setting targets for diabetes patients should include a discussion between the patient and the doctor. Every patient is an individual person and their care needs to be individualized. We concluded that for most patients an HbA1c between 7% and 8% represents the range that maximizes benefit and limits harms. There are patients, however, for whom the HbA1c targets can be relaxed or have no target at all, particularly those patients with underlying comorbid illnesses, such as the elderly and patients with cancer.
And there are patients who are very interested in achieving a lower HbA1c target and if that’s important to the patient and the doctor believes that this can be achieved without substantial harm then that certainly is an appropriate target.
The ACP, like all the other societies, believes that lifestyle modification, ie, diet and exercise and certainly smoking cessation, remains at the forefront of diabetes care. If a patient can achieve an HbA1c target of 6.5% or less only with diet and exercise, then that’s absolutely where care should be directed. Lifestyle modifications do not convey harms and are not associated with side effects or even increased costs. So, if patients can achieve a HbA1c target of 6.5% or less with life style modifications, then that’s the way to go.
What we’ve found and what our recommendations, therefore, convey is that when clinicians have to add medication to medication to medication to achieve a target that is not associated with increased benefits but is associated with increased cost, burden and harm, that is where we take issue and that’s what makes this guidance statement so important.
In coming out with guidance statements for HbA1c goals that may be less intense compared with those of other societies, in no way is ACP saying that diabetes should not be carefully managed. What ACP is saying, is that for patient safety, for decreasing cost and for maximizing benefits, for most patients targets should be between 7% and 8%, which differs from what other societies recommend.
Perspective
Back to TopJonathan Leffert, MD, FACP, FACE, ECNU
The AACE guideline on this, as well as our 2018 algorithm, recommends an HbA1c in the range of 6.5%, while recognizing that goals should be personalized for people with certain comorbidities. We are trying to prevent the complications of diabetes, which include not only microvascular complications, but macrovascular complications like heart disease and vascular disease.
Today, we have new agents that not only treat diabetes, but also reduce CV risk. These agents are tools that can safely and effectively lower blood sugars in people with diabetes to an HbA1c range that improves their long-term risk for complications. We have an opportunity to treat people aggressively because we see, unfortunately, that diabetes is still increasing in the population.
We have almost 30 million people with diabetes and 80 million people with prediabetes. One out of 3 Medicare dollars is spent on diabetes or the related complications of diabetes. We can’t take the approach that we should loosen the HbA1c target at this point. In fact, we have opportunities to intensify regimens for patients. Hypoglycemia can be managed with accurate blood glucose-monitoring devices and continuous glucose monitoring in those patients who are being managed intensively.
From the perspective of AACE, we think that the ACP recommendation is going in the wrong direction. The right direction is to continue to work to actively manage patients to the goal of an HbA1c of 6.5% and to personalize the management of all patients to decrease the complications of diabetes while trying to avoid hypoglycemia. That should be the goal of diabetes management in 2018.
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