September 10, 2014
Burdens of Treatment Offset Benefit in Some
Diabetes Patients 

Ann Arbor, MI—The current approach of broadly advocating intensive glycemic control is being called into question by a new study that suggests that treatment of diabetes patients with HbA1c levels less than 9% should be individualized and should take into consideration the burdens of treatment.

The study by researchers from the Veterans Affairs (VA) Ann Arbor, MI, Healthcare System, the University of Michigan Health System, and University College in London was published in the August issue of JAMA Internal Medicine.

The researchers suggest, for example, that, especially for patients older than 50 with type 2 diabetes, side effects such as weight gain or the burden of frequent insulin shots might outweigh the benefits of treatments.

While current guidelines for type 2 diabetes recommend intensifying treatment until the patient’s hemoglobin A1c drops to a certain level, the researchers argued that the overall benefit from treatment may have as much or more to do with safety, side effects, and inconvenience than blood sugar.

“For people with type 2 diabetes, the goal of managing blood sugar levels is to prevent associated diabetes complications, such as kidney, eye and heart disease, but it is essential to balance complication risks and treatment burdens when deciding how aggressively to treat blood sugars,” explained lead author Sandeep Vijan, MD, MS, a research scientist at the Center for Clinical Management Research at the VA Ann Arbor Healthcare System and a professor at the University of Michigan Medical School.

“If you’re a patient with fairly low complication risks but are experiencing symptoms from low blood sugar, gaining weight or find frequent insulin shots to be disruptive to your daily life, then the drugs are doing more harm than good. Prescribing medicine isn’t just about reducing risks of complications, but also about helping patients improve their quality of life,” Vijan added.

He pointed out that, for many patients, little additional benefit accrues after moderate levels of glucose control are achieved, yet treatment costs, risks and hassles continue to increase.

The study found that, assuming a low treatment burden (0.001, or 0.4 lost days per year), treatment that lowered HbA1c level by 1% provided benefits ranging from 0.77 to 0.91 quality-adjusted life years (QALYs) for simulated patients who received a diagnosis at age 45 years compared to 0.08 to 0.10 QALYs for those who received a diagnosis at age 75 years.

The study, which excluded the 15% to 20% of type 2 diabetes patients with very high blood sugar levels who require intensive treatment, found that the benefits of treatment decline with age and, by 75, the harms of most treatments are likely to outweigh any benefits.

“Improving glycemic control can provide substantial benefits, especially for younger patients; however, for most patients older than 50 years with an HbA1c level less than 9% receiving metformin therapy, additional glycemic treatment usually offers at most modest benefits,” according to the researchers.

The authors recommend that, instead of focusing only on glucose goals, a better approach for healthcare providers would be to individualize treatment based on patients’ estimated risk of diabetes complications—taking into account their ages and degree of blood glucose elevation—as well as the side effects and amount of safety data of the medication being considered.

This wasn’t the first study to challenge “treat-to-target” guidelines, which are widely used in medicine. Hypertension guidelines were significantly changed last year after research concluded the risks outweighed benefits of drugs intended to achieve specific blood pressure goals in some patients. Similar recommendations also have been implemented for lipid lowering therapy, the study pointed out.

U.S. Pharmacist Social Connect