Intensive glucose therapy during hospitalization for stroke does not improve functional outcomes (SHINE)

Reference

Johnston KC, Bruno A, Pauls Q, et al, for the Neurological Emergencies Treatment Trials Network and the SHINE Trial Investigators. Intensive vs. standard treatment of hyperglycemia and functional outcome in patients with acute ischemic stroke. JAMA 2019;322(4):326-335.

Synopsis

Hyperglycemia in patients hospitalized with acute ischemic stroke is common. In this multicenter trial, patients with acute ischemic stroke presenting within 12 hours of stroke onset who also had hyperglycemia (glucose > 110 mg/dL in patients with type 2 diabetes, or > 150 mg/dL in patients without type 2 diabetes) were randomized into 1 of 2 groups: (1) an intensive treatment group (n = 581) who received continuous intravenous insulin with computer decision support to maintain a blood glucose level of 80 - 130 mg/dL; or (2) a standard treatment group (n = 570) who received sliding scale insulin every 6 hours to maintain a blood glucose level of 80 - 179 mg/dL. The treatment period was for 72 hours. The 2 groups were similar at baseline: the mean age was 66 years, 80% had history of type 2 diabetes, 80% had strokes classified as mild to moderate, and 68% received reperfusion therapies. The primary end point was a favorable outcome on the modified Rankin scale at 90 days. (The range of Rankin scores considered to be favorable varied based on the severity of the stroke.) During the treatment period, the mean glucose level in the intensive group was much lower than the standard group (118 mg/dL vs 179 mg/dL). However, there was no significant difference detected in the primary end point, with approximately 20% of patients in each group showing a favorable functional outcome at 90 days. More patients in the intensive group had treatment stopped because of hypoglycemia and other adverse events (11.2% vs 3.2%). Additionally, 15 patients in the intensive group experienced severe hypoglycemia (glucose < 40 mg/dL) compared with zero patients in the standard group.