This article is more than 5 years old. Information may no longer be current.
Aggressive glucose control fails to improve outcomes after stroke
Click Here to Manage Email Alerts
Hospitalized patients who developed hyperglycemia after acute ischemic stroke experienced similar outcomes when treated with insulin to an intensive glucose target vs. standard therapy, regardless of type 2 diabetes status, according to findings published in JAMA.
Hyperglycemia is present in approximately 40% of patients with acute ischemic stroke and is associated with worse outcomes when compared with normal blood glucose levels, Karen C. Johnston, MD, professor of neurology and associate vice president of clinical and translational research at the University of Virginia, Charlottesville, and colleagues wrote in the study background.
“Data suggest that hyperglycemia during acute brain ischemia augments the ischemic injury by multiple potential mechanisms, such as endothelial dysfunction, increased oxidative stress and impaired fibrinolysis,” the researchers wrote.
Johnston and colleagues analyzed data from 1,151 adult patients with hyperglycemia (blood glucose 110 mg/dL with diabetes or 150 mg/dL without diabetes) and acute ischemic stroke who were enrolled within 12 hours from stroke onset at 63 U.S. sites between April 2012 and August 2018 as part of the SHINE study (mean age, 66 years; 46% women; 80% with diabetes). Researchers randomly assigned patients to continuous IV insulin using a computerized decision support tool, at a target blood glucose concentration of 80 mg/dL to 130 mg/dL (intensive treatment; n = 581) or to insulin on a sliding scale at a target blood glucose concentration of 80 mg/dL to 179 mg/dL (standard treatment; n = 570) for up to 72 hours. After 90 days, the patients were evaluated for disability, neurologic function and quality of life. Primary outcome was the proportion of patients with a favorable outcome based on the 90-day modified Rankin Scale score, a global stroke disability scale ranging from 0 (no symptoms or completely recovered) to 6 (death), adjusted for baseline stroke severity.
The results suggested that the two treatments were equally effective at helping the patients recover from their strokes. After 90 days, about 20% of the patients showed favorable outcomes regardless of whether they were given intensive or standard treatment, according to researchers.
During treatment, the mean blood glucose level was 118 mg/dL in the intensive treatment group and 179 mg/dL in the standard treatment group. A favorable outcome occurred in 119 patients (20.5%) in the intensive treatment group and in 123 patients (21.6%) in the standard treatment group, for an adjusted RR of 0.97 (95% CI, 0.87-1.08). Treatment was stopped early for hypoglycemia or other adverse events in 65 patients (11.2%) in the intensive treatment group and in 18 patients (3.2%) in the standard treatment group, according to researchers.
Severe hypoglycemia occurred only among patients in the intensive treatment group (2.6%; risk difference, 2.58%; 95% CI, 1.29-3.87).
Intense glucose therapy also required a higher level of care, with increased supervision from nursing staff, when compared with standard treatment, the researchers noted.
The SHINE study was stopped early when a preplanned, interim analysis revealed that intensive glucose control did not improve outcomes compared with standard treatment, according to the researchers.
“We found that the extra risks associated with aggressive treatment were not worth it,” Johnston said in a press release. “We are so grateful to the patients and research teams from across the country who helped us answer this important question. As a result of their participation, patients around the world will benefit.” – by Regina Schaffer
Disclosures: The National Institute of Neurological Disorders and Stroke supported this study. Johnston reports she served on the National Institute of Neurological Disorders and Stroke advisory council and the FDA neurological devices panel.
Perspective
Back to TopElif Ekinci, MBBS, FRACP, PhD
This is an important study, as we did not have clinical trial data in the acute stroke setting on the effect of insulin infusions on stroke outcomes.
Insulin infusions can increase the risk of severe hypoglycemia, as was seen in this study, and a severe hypoglycemic episode may be particularly dangerous in the stroke setting when individuals cannot communicate due to their stroke. Insulin infusion takes up a lot of time for staff to administer. It is essential to note that the trial used insulin infusions to lower glucose levels. Glucose lowering agents which do not cause hypoglycemia may be advantageous in the acute stroke setting; however, such studies in the acute setting are scarce. Further studies using agents which do not cause hypoglycemia are needed before ruling out the potential benefit of glucose lowering in the acute stroke setting.
Click Here to Manage Email Alerts