07 Jun Intensive Glucose Control Still Attempted in Frail Patients, Risking Hypoglycemia
MedicalResearch.com Interview with:
Rozalina McCoy, M.D
Assistant Professor of Medicine
Division of Primary Care Internal Medicine
Department of Medicine
Mayo Clinic Rochester
MedicalResearch.com: What is the background for this study?
Dr. McCoy: Hypoglycemia is a serious potential complication of diabetes treatment; it worsens quality of life and has been associated with cardiovascular events, dementia, and even death. Most professional societies recommend targeting HbA1C levels less than 6.5% or 7%, with individualized treatment targets based on patient age, other medical conditions, and risk of hypoglycemia with therapy. Treating patients to very low HbA1c levels is not likely to improve their health, especially not in the short-term, but can cause serious harms such as hypoglycemia. The goal of our study was to assess how frequently patients with type 2 diabetes are treated intensively, focusing specifically on patients who are elderly or have serious chronic conditions such as dementia, kidney disease including dialysis need, heart disease, stroke, lung disease, and cancer. Moreover, while prior studies have suggested that intensive treatment may be common, there was no strong evidence that intensive treatment does in fact increase risk of hypoglycemia. Our study was designed specifically to assess this risk.
We examined medical claims, pharmacy fill data, and laboratory results of 31,542 adults with stable and controlled type 2 diabetes who were included in the OptumLabs™ Data Warehouse between 2001 and 2013. None of the patients were treated with insulin or had prior episodes of severe hypoglycemia, both known risk factors for future hypoglycemic events. None of the patients had obvious indications for very tight glycemic control, such as pregnancy.
“Intensive treatment” was defined as being treated with more glucose-lowering medications than clinical guidelines consider to be necessary given their HbA1C level. Patients whose HbA1C was less than 5.6 percent (diabetes is defined by HbA1C 6.5 percent or higher) were considered intensively treated if they were taking any medications. Patients with HbA1C in the “pre-diabetes” range, 5.7-6.4 percent, were considered to be intensively treated if using two or more medications at the time of the test, or if started on additional medications after the test, because current guidelines consider patients with HbA1C less than 6.5 percent to already be optimally controlled. For patients with HbA1C of 6.5-6.9 percent the sole criteria for intensive treatment was treatment intensification with two or more drugs or insulin.
The patients were separated by whether they were considered clinically complex (based on the definition by the American Geriatrics Society)—75 years of age or older; or having end-stage kidney disease, dementia; or with three or more serious chronic conditions. This distinction has been made to help identify patients for whom adding glucose-lowering medications is more likely to lead to treatment-related adverse events, including hypoglycemia, while not providing substantial long-term benefit.
MedicalResearch.com: What are the main findings?
Dr. McCoy: We found that of the 31,542 patients in the study, 18.7% of clinically complex patients, and 26.5% of non-complex patients, were treated intensively. Clinically complex patients had nearly double the rate of severe hypoglycemia than non-complex patients, and intensive treatment increased it by an additional 77%, from 1.74% to 3.04% over two years. Younger patients, and patients without serious chronic comorbidities, were able to tolerate intensive treatment better and without increase in severe hypoglycemic events (1.02% with standard treatment and 1.30% with intensive treatment)
MedicalResearch.com: What should readers take away from your report?
· Intensive treatment is very common, including among older patients and patients with multiple chronic conditions. Many patients with type 2 diabetes receive intensive treatment to keep their HbA1c less than 7%, and some as low as 5.6%. This includes 26.5% of patients younger than 75 years who do not have serious chronic illnesses, and 18.7% of patients who are over 75 years old and/or have serious chronic illnesses.
· Intensive treatment significantly increases the risk of severe hypoglycemia among older patients and patients with serious chronic conditions. While prior studies have assumed that intensive treatment is harmful because it would increase hypoglycemia risk, this link has actually not been previously established in large population-based studies.
· intensive treatment did not affect all patients equally. Patients who are younger and do not have any significant illnesses were able to tolerate intensive treatment without increase in severe hypoglycemia risk. So the risk of hypoglycemia was primarily among the older, and more clinically complex, patients.
· When glucose-lowering medications are used in combination there is potential for hypoglycemia even without insulin and sulfonylurea use.
· Physicians should always ask their patients about hypoglycemic events and not be afraid to de-intensify therapy among patients who are intensively treated and have low HbA1c, especially among patients who are older and/or clinically complex
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
· Additional studies are needed to identify safe and effective strategies for treatment de-intensification
· Clinical practice guidelines and performance metrics should include measures of safety, and specifically hypoglycemia, in their consideration of high quality patient-centered care
MedicalResearch.com: Is there anything else you would like to add?
Dr. McCoy: We should recognize the harms of intensive treatment and hypoglycemia, particularly when there is little likely benefit of keeping HbA1c low in the setting of limited life expectancy or multiple comorbidities. The goal of diabetes care should be achieving blood sugars in a safe range – not too high but also not too low. It is time that we, as physicians and patients, recognize that high quality diabetes care should emphasize not only avoiding hyperglycemia but also preventing hypoglycemia
MedicalResearch.com: Thank you for your contribution to the MedicalResearch.com community.
Rozalina G. McCoy, Kasia J. Lipska, Xiaoxi Yao, Joseph S. Ross, Victor M. Montori, Nilay D. Shah. Intensive Treatment and Severe Hypoglycemia Among Adults With Type 2 Diabetes. JAMA Internal Medicine, 2016; DOI:10.1001/jamainternmed.2016.2275
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