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Intensive vs. Standard Treatment of Hyperglycemia in Acute Ischemic Stroke
Study Questions:
Do stroke patients with hyperglycemia have better 90-day functional outcomes when they are treated with intensive rather than standard glucose control in the early days post-stroke?
Methods:
SHINE (Stroke Hyperglycemia Insulin Network Effort) is a multicenter, randomized trial of patients with hyperglycemia and acute ischemic stroke with National Institutes of Health Stroke Scale (NIHSS) scores of 3-22. Hyperglycemia in patients with type 2 diabetes was defined as a glucose level >110 mg/dl. Hyperglycemia in patients without type 2 diabetes was defined as a level ≥150 mg/dl. Patients with type 1 diabetes were not eligible. Patients in the intensive group received an insulin infusion to maintain a glucose concentration of 80-130 mg/dl. Patients in the standard group received insulin via sliding scale every 6 hours as needed to maintain a glucose concentration of 80-179 mg/dl as well as an intravenous saline drip to maintain patient blinding. Treatment was continued for 72 hours or until death or discharge. The primary outcome was the proportion of patients with a favorable outcome (as defined by NIHSS score) at 90 days.
Results:
A total of 1,151 patients were randomized, 920 (80%) of whom had type 2 diabetes. Study enrollment was stopped for futility after a prespecified interim analysis. The mean glucose concentration for the intensive group was 118 mg/dl (95% confidence interval [CI], 115-121 mg/dl) and for the standard group was 179 mg/dl (95% CI, 175-182 mg/dl). A favorable outcome occurred in 119 of 581 patients (20.5%) in the intensive group and in 123 of 570 patients (21.6%) in the standard group (adjusted risk ratio, 0.97; 95% CI, 0.87-1.08). Severe hypoglycemia (glucose <40 mg/dl) occurred in 15 patients (2.6%) in the intensive group and in 0 patients in the standard group (p < 0.001).
Conclusions:
In this randomized trial of acute ischemic stroke patients with hyperglycemia, patients treated with intensive rather than standard glucose control in the early days post-stroke did not have better 90-day functional outcomes.
Perspective:
Hyperglycemia is observed in over one-third of all acute ischemic stroke patients. In observational studies, hyperglycemia is associated with worse post-stroke clinical outcomes. Given this knowledge, many in the stroke community suspected that intensive blood glucose control would improve functional outcomes among hyperglycemic acute ischemic stroke patients. The SHINE trial has provided high-quality evidence that this is not the case. Moving forward, post-stroke glucose management will continue to entail subcutaneous insulin and a goal glucose level <180 mg/dl.
Clinical Topics: Prevention
Keywords: Blood Glucose, Brain Ischemia, Diabetes Mellitus, Type 2, Glucose, Hyperglycemia, Hypoglycemia, Insulin, Patient Discharge, Primary Prevention, Risk, Stroke, Vascular Diseases
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