NASHVILLE, TN—Adding insulin or sulphonylurea to metformin increased the risk of death among veterans with diabetes in the initial six- and 12-month period, according to a recent study.
Insulin increased the risk of death 66% more than sulfonylurea at six months, but the difference was not significant at 12 months, the report in Diabetes, Obesity and Metabolism.stated.
The researchers hoped to shed light on an association between tight glycemic control and death found in the landmark ACCORD trial by studying the mediating effects of hypoglycemia and body mass index.
“There was a strong association between hypoglycemia and all-cause death with patients who increased treatment with either drug” (insulin or sulfonylurea), said Christianne L. Roumie, MD, MPH, investigator, VHA-Tennessee Valley Healthcare System Geriatric Research Education Clinical Center, staff physician, Nashville VAMC, and associate professor, Vanderbilt University School of Medicine. “Severe hypoglycemia can lead to really poor outcomes, including cognitive impairment and death, but it is also a marker for other underlying health issues.”
Previous studies have had conflicting conclusions about the association between insulin use and increased risk of death, so the researchers sought to determine whether insulin had a greater association with mortality than sulfonylurea. If so, did hypoglycemia or BMI play a role?
Essentially they asked, “If you got insulin, did it lead to hypoglycemia and did hypoglycemia lead to death?” Roumie told U.S. Medicine.
Any instance of severe hypoglycemia that required a trip to the emergency department or hospitalization or was indicated by an outpatient blood glucose reading of less than 60 mg/dL during the first 12 months of intensified therapy with either drug tripled the risk of death, they discovered. They did not analyze the effect of mild or moderate hypoglycemia.
Still, the increased risk of death associated with insulin at six months remained the same with or without inclusion of severe hypoglycemia in the model. That indicated that “hypoglycemia was a strong predictor of death, but it did not appear to mediate the association,” the authors wrote.
Several factors might explain the disappearance of a difference in mortality rates at and after 12 months. “Healthier patients were likely included in the analysis compared to those who only survived six months, as many patients who had advanced disease or comorbidities could have died in that first year,” said Roumie. “The effect of insulin may also have differed among those who were healthier.”
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