With Anil Makam, MD, MAS and Caroline Apovian, MD, FACP, FACN
Overtreatment of type 2 diabetes (T2D) is difficult to explain with brevity, but it's common, potentially detrimental, and very costly,1 said Anil Makam, MD, MAS, assistant professor of internal medicine at UT Southwestern Medical Center. He co-authored a recent review looking at evidence-based medicine to prevent overtreatment of T2D, which was published in Circulation.
"When you are overtreating patients, there is a low chance they will benefit from treatment and a reasonable chance they will be harmed from the therapy itself," Dr. Makam told EndocrineWeb.
He indicated that evidence-based medicine is often derided as ''practice by rote algorithmic medicine," yet applying key, evidence-based medicine principles in clinical decision-making is crucial to assure proper treatment and promote patient-centered care.
Dr. Makam identified 5 key clinical strategies that he believes endocrinologists and PCPs--caring for those with T2D--should focus on now, in an interview with EndocrineWeb, based on conclusions drawn from his study findings.1
Intensive glycemic control, defined in randomized clinical trials as that which results in an HbA1C value of 6.4% to 7%, has been linked with multiple benefits, including less retinopathy, neuropathy, microalbuminuria and nonfatal myocardial infarction, Dr. Makam said.
However, he added, many of the reported benefits are more commonly linked with intermediate outcomes that would go unnoticed by the patient, such as less protein in the urine. "It's never been shown, in a large, randomized clinical trial with up to 15 years of follow-up that treating to such intensive levels changes patient-centered outcomes," he said.
In the paper, he noted that in the landmark United Kingdom Prospective Diabetes Study (UKPDS), which followed more than 5,000 patients with T2D, the relative benefits of a decade of intensive control for those with newly diagnosed diabetes ''were only demonstrated for intermediate markers of microvascular complications,'' such as progression of retinopathy on an eye exam, but no meaningful clinical manifestations such as vision loss were noted by the patients.1
Instead of applying the same 7% and below criteria, he believes the HbA1C endpoint should be softened for many, treating to more modest levels of 7.9 to 8.4%. The new ballpark? "Overall, we think aiming for an A1C of less than 9% in most who have diabetes makes better sense," Dr. Makam said.
After monitoring, doctors can ''then consider whether an intensive glycemic control strategy would benefit the patient."
''We have focused on relative benefits," Dr. Makam said of most diabetes-related research. Rather, "we need to focus on absolute benefits." What really matters? Vision changes, for instance, he offered, and what matters less? Changes on a retinal scan or changes in nerve function that patients don't complain about.
Dr. Makam said he never considers age alone, for instance, but takes into consideration the entire patient when discussing treatment options. Among the usual considerations are their life expectancy, the presence of other physical illnesses, any dementia, frailty, and functional impairments.
Physicians need to be sure patients understand the pros and cons of different treatments, especially those in ''gray areas,'' where more than one treatment might be appropriate, Dr. Makam said.
He approaches the discussion with his patients in a straightforward manner, such as: "Look, we can be more aggressive, and we might lower your risk for kidney disease or going blind, but it's a small risk; it might be 1 in 100. There's a higher risk you may gain weight with insulin."
Often, he said, the patient in that scenario will come say he is comfortable with the slightly higher risk of complications but would prefer to avoid insulin and weight gain.
Most importantly, Dr. Makam lets the patient know that he thinks it is a reasonable decision, a critical factor in fostering a trusting physician-patient relationship.
5.Take Patient Preferences and Quality of Life Into Account
Once patients are given the whole story, they are in a better position to decide what's acceptable to them or not, Dr. Makam said, and they can let their wishes be known.
While it may seem obvious, a patient's quality of life (QoL) is a fundamental factor to consider, Dr. Makam said. For instance, those in the UKPDS trial reported, on average, that intense glycemic control had the same effect on lowering their QoL as they would perceive a mild stroke would have. That was due, he said, to the need for multiple injections of insulin, frequent blood glucose monitoring, and repeated and regular health care visits.
One discussion about preferences is just not enough, he said; rather, it must be ongoing. Patient preferences can change or evolve over time, and by acknowledging this, clinicians will come closer to delivering patient-centered care, according to Dr. Makam.
This paradigm shift in treatment was welcomed by Caroline Apovian, MD, FACP, FACN, a professor of medicine and pediatrics in endocrinology, diabetes, and nutrition at Boston University School of Medicine, who commented on the study for EndocrineWeb.
"The best statement in this article is the one that posits abandoning the notion that HbA1C levels less than 7% are well-controlled and that those greater than 7% are poorly controlled. This posit will encourage providers to stop looking at and treating numbers instead of treating the patient," said Dr. Apovian.
She views overtreatment as ''the aggressive lowering of HbA1c and glucose that then may lead to hypoglycemic events and impaired quality of life that may outweigh the benefits of tight glycemic control on microvascular complications."
When discussing treatments, she said, ''the benefits versus risk equation should include the risk of weight gain and an increase in cardiovascular events related to that weight gain."
Despite what some may think, overtreatment doesn't stem from a fear of liability, Dr. Makam said. It's more of an occupational hazard, in his view. "Overuse is inherently built into the medical approach physicians have been trained to take in caring for patients," Dr. Makam said.
What is needed, and is beginning to happen, is a reframing the standards of care. "The American Diabetes Association guidelines2 have been slowly rolling back over the last decade," he says, in that it recognizes tight control is not for everyone.2
"It's not just an age thing,'' he says in deciding the level of control. It's about taking all the strategies he focused on into account and finding the best fit for the patient, Dr. Makam said.