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Reducing Diabetes Overtreatment

By Jamie Santa Cruz

Physicians should discuss with patients the risks and benefits of various diabetes treatment options and base treatment decisions on an individual's age, health status, and life expectancy.

Despite concern that the harms of intensive glycemic control in older adults can outweigh the benefits, a study recently published in JAMA Internal Medicine found that a large proportion of elderly adults with diabetes mellitus, including those in compromised health, were nevertheless reaching tight glycemic targets.1

According to Kasia Lipska, MD, MHS, an assistant professor of endocrinology at Yale School of Medicine and the study's lead author, the results suggest that many of the study subjects were potentially being overtreated, meaning they likely received treatment carrying more risk of harm than promise of benefit. "Many of these patients who reached tight glycemic targets had compromised health and used medicines [specifically insulin and sulfonylureas] that can lead to hypoglycemia," Lipska says.

Changing Recommendations on A1c Targets
Although a hemoglobin A1c value of less than 7% was previously recommended typically for patients with diabetes, recommendations have changed considerably in recent years, says Leonard Pogach, MD, MBA, national director of medicine at the Veterans Health Administration. Most medical groups, including the American Geriatrics Society (AGS) and the American Diabetes Association (ADA), now agree that while a low target value is reasonable for younger and healthier patients, patients who are older or sicker can have higher targets. The Choosing Wisely recommendations of the AGS explicitly recommend using medications to achieve target values of less than 7.5% for most individuals aged 65 and older.2

Lipska's research, however, found that most older adults, even those in poorer health, were still reaching tight glycemic targets, and they were using medication to do so. The study, which relied on data from the National Health and Nutrition Examination Survey between 2001 and 2010, analyzed more than 1,200 patients with diabetes who were aged 65 and older. Just over 60% had a hemoglobin A1c value of less than 7%, and that percentage did not change significantly over the 10 years of the study period. It also did not vary significantly based on whether the patient was in relatively good health, complex/intermediate health, or very complex/poor health.

Such intensive treatment is likely to do more harm than good, Lipska says. "What we know is that older patients are more susceptible to side effects of therapy, and particularly hypoglycemia," she explains. "Many of the medications may cause low blood sugar levels, and we know that older patients with diabetes are more likely to have a low blood sugar reaction than younger patients."

An increasing amount of research underscores the problem of hypoglycemia in older adults with diabetes. A 2011 study in The New England Journal of Medicine found that each year there are nearly 100,000 emergency hospitalizations for adverse drug events in adults over the age of 65, with glucose-lowering agents implicated in approximately one in four of those hospitalizations, almost all of them for hypoglycemia.3 Moreover, previous research from Lipska and her colleagues, published last year in JAMA Internal Medicine, found that hospitalizations for hypoglycemia now outpace those for hyperglycemia among older adults in the United States.4

One reason hypoglycemia is such a common adverse drug event, according to Pogach, is that diabetes is difficult to manage, particularly for elderly patients. Successful management involves attention to nutrition, exercise, and the timing of medications. In many cases, adverse drug events occur not because the patient has too low a target goal, but because of errors, because the patient gets sick, or because of interruptions in nutrition.

However, there is increasing recognition that hypoglycemia in older adults with diabetes is often due to their A1c targets being too tight—to the point where the benefit is relatively minimal compared with the risk. For that reason, he says, the last few years have seen an increasing stress in the diabetes community on the importance of evaluating risks and benefits in the treatment of older adults with diabetes, as well as on the importance of individualized target goals and shared decision making.

Factors Promoting Overtreatment
Despite changing recommendations, Lipska believes that many physicians may not be fully cognizant of the issue of overtreatment. "I don't think that clinicians are as aware, because I wasn't aware until recently," Lipska says. "We see a problem of poor control a lot in clinical practice, and that's where our attention most often lies. It's a little bit harder for us to notice patients who are overtreated because they are reaching the targets that have been ingrained in our profession." Pogach agrees, saying that the message about the problem of overtreatment is available, but it's unclear how widely it's being received.

One reason the medical profession may be struggling with accepting the message is that the medical profession endorsed a single target for so long. "There have been a lot of public health campaigns, performance metrics in place, and educational campaigns for both clinicians and patients that have really hit hard on a simple message, which is get your patient (or yourself) an A1c under 7%," Lipska says. "That's been a very powerful message that's been in place."

A compounding factor, Lipska says, is the fact that it is much easier in clinical practice to have one simple target for everyone than to sit with patients and discuss where that target should lie and which medicines could be used, especially since there is a lack of good data about exactly how older or sicker patients should be treated. The pharmaceutical industry likely does not help, Lipska says, because the industry has a vested interest in selling their drugs to as many patients as possible, therefore exacerbating the overtreatment problem.

Improving Diabetes Patients' Care
• Individualize treatment. Rather than putting all older diabetes patients into a one-size-fits-all treatment plan, physicians should tailor treatment to the individual, says Pogach. The ADA and the AGS both suggest that an A1c value of less than 7.5% is reasonable for older adults who are healthy and have a longer life expectancy. For those with complex intermediate conditions, a target of 8% is reasonable, and for those with multiple comorbidities, the target can be pushed all the way up to 8.5 or 9%.2,5 "There's not a magic number, but there are ranges," Pogach says. In deciding on a target goal, he adds, physicians should bear in mind that all patients will receive more dramatic benefits by moving from a value of 9% to 8% compared with going from 8% to 7%.

• Choose medications carefully. In Lipska's view, insulin and sulfonylureas continue to have a place in the treatment of older diabetes patients, as long as they are not used to achieve overly tight glycemic control. Not all agree with her, however. Alan Garber, MD, PhD, a professor of diabetes, endocrinology, and metabolism at Baylor College of Medicine, argues that tight glycemic control isn't the primary problem; the larger problem is the specific medications being used to achieve that control. Sulfonylureas and older forms of insulin are known to carry a significant risk of hypoglycemia, but newer glucose control agents have a much smaller risk of hypoglycemia. Rather than abandoning tight glycemic targets, he argues, the better strategy is to continue to aim for low targets but to use newer medications that carry lower hypoglycemia risk.

• Consider the patient's residual lifespan. The younger the patient and the longer his or her life expectancy, the more likely it is that complications of diabetes will occur, and the greater the benefit of tight glycemic control, Pogach says. Garber agrees, noting that most 65-year-old patients have more than a 10-year residual lifespan, and with a time horizon of 10+ years, the degree of glucose control can matter substantially. "Control really can't be avoided, because [without tight control] you're going to condemn the patient to a visual or kidney issue," Garber says. "You need to bear in mind a reasonably accurate assessment of residual lifespan for each patient when making a treatment decision."

• Practice shared decision-making. Some patients, Lipska says, are relatively comfortable with the immediate harms of hypoglycemia, feeling that they understand and can control the risk, but they are very interested in preventing long-term complications of their diabetes. On the other hand, other patients are so terrified of having a hypoglycemic reaction that the potential benefits of long-term tight control are less important.

Because there is a range of treatment options and individuals have different goals and preferences regarding their own care, physicians should discuss with patients the risks and benefits of various treatment options and invite patients into the decision-making process, Pogach says. "The doctor and patient and the team should negotiate this," he says.

— Jamie Santa Cruz is a freelance writer based in Englewood, Colorado.

References
1. Lipska KJ, Ross JS, Miao Y, Shah ND, Lee SJ, Steinman MA. Potential overtreatment of diabetes mellitus in older adults with tight glycemic control. JAMA Intern Med. 2015;175(3):356-362.

2. Ten things physicians and patients should question. Choosing Wisely website. http://www.choosingwisely.org/doctor-patient-lists/american-geriatrics-society. Accessed February 24, 2015.

3. Budnitz DS, Lovegrove MC, Shehab N, Richards CL. Emergency hospitalizations for adverse drug events in older Americans. N Engl J Med. 2011;365(21):2002-2012.

4. Lipska KJ, Ross JS, Wang Y, et al. National trends in US hospital admissions for hyperglycemia and hypoglycemia among Medicare beneficiaries, 1999 to 2011. JAMA Intern Med. 2014;174(7):1116-1124.

5. American Diabetes Association. Standards of medical care in diabetes – 2015. Diabetes Care. 2015;38 Suppl 1:S1-S93.