The risk of severe hypoglycemia is higher among certain subgroups of diabetes patients than those in randomised clinical trials, according to new research.
Researchers at the Wisconsin School of Medicine and Public Health, United States, evaluated the electronic health records of approximately one million adults with diabetes who received care during 2005-2011. Roughly 95 of the participants had type 2 diabetes.
The annual rates of severe hypoglycemia ranged from 1.4 to 1.6 events per 100 person-years, and were higher among younger and older age groups, as well as those with cardiovascular disease, higher HbA1c levels and chronic kidney disease. Rates in the youngest age group (20-44 years) were higher than older groups, and the researchers note this likely reflects a higher prevalence of type 1 diabetes.
These results were compared to 0.3 and 1.0 rates seen in patients from randomised trials, including Action to Control Cardiovascular Risk in Diabetes (ACCORD), Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified Release Controlled Evaluation (ADVANCE), and Outcome Reduction With Initial Glargine Intervention (ORIGIN).
Episodes of severe hypoglycemia were more prevalent among patients taking insulin, insulin secretagogues and beta-blockers; patients with depression at baseline had a 50 per cent greater risk for severe hypoglycemia, and patients who had two or more severe hypos per year tended to have more comorbidities.
Study author Dr. Kasia J Lipska, MD, explained the findings to Medscape Medical News. Lipska said: “The rates of severe hypoglycemia are usually much lower in randomised clinical trials than in real-world populations.
“That’s most likely because patients recruited for clinical trials are typically healthier and less likely to experience hypoglycemia compared with the complex patients we see in clinical practice. I worry that clinicians underappreciate the risk of hypoglycemia among people with type 2 diabetes and the impact it has on people’s lives.”
The researchers concluded: “Strategies that reduce the risk of hypoglycemia in high-risk patients are needed….These data can inform the development of clinical management strategies to more effectively reduce the occurrence of severe hypoglycemia in community-treated patients.”
The study was published in the online journal Diabetes Care.