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JAMA. 2019 Jul 23;322(4):326-335. doi: 10.1001/jama.2019.9346.

Intensive vs Standard Treatment of Hyperglycemia and Functional Outcome in Patients With Acute Ischemic Stroke: The SHINE Randomized Clinical Trial.

Author information

1
Department of Neurology, University of Virginia, Charlottesville.
2
Department of Neurology, Medical College of Georgia, Augusta University, Augusta.
3
Department of Public Health Sciences, Medical University of South Carolina, Charleston.
4
Department of Neurology and Neurotherapeutics, UT Southwestern Medical Center, Dallas, Texas.
5
Department of Neurology, Mayo Clinic Florida, Jacksonville.
6
Department of Emergency Medicine, University of Michigan, Ann Arbor.
7
Brain Institute, University of Virginia, Charlottesville.
8
National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, Maryland.

Abstract

Importance:

Hyperglycemia during acute ischemic stroke is common and is associated with worse outcomes. The efficacy of intensive treatment of hyperglycemia in this setting remains unknown.

Objectives:

To determine the efficacy of intensive treatment of hyperglycemia during acute ischemic stroke.

Design, Setting, and Participants:

The Stroke Hyperglycemia Insulin Network Effort (SHINE) randomized clinical trial included adult patients with hyperglycemia (glucose concentration of >110 mg/dL if had diabetes or ≥150 mg/dL if did not have diabetes) and acute ischemic stroke who were enrolled within 12 hours from stroke onset at 63 US sites between April 2012 and August 2018; follow-up ended in November 2018. The trial included 1151 patients who met eligibility criteria.

Interventions:

Patients were randomized to receive continuous intravenous insulin using a computerized decision support tool (target blood glucose concentration of 80-130 mg/dL [4.4-7.2 mmol/L]; intensive treatment group: n = 581) or insulin on a sliding scale that was administered subcutaneously (target blood glucose concentration of 80-179 mg/dL [4.4-9.9 mmol/L]; standard treatment group: n = 570) for up to 72 hours.

Main Outcomes and Measures:

The primary efficacy 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]) that was adjusted for baseline stroke severity.

Results:

Among 1151 patients who were randomized (mean age, 66 years [SD, 13.1 years]; 529 [46%] women, 920 [80%] with diabetes), 1118 (97%) completed the trial. Enrollment was stopped for futility based on prespecified interim analysis criteria. During treatment, the mean blood glucose level was 118 mg/dL (6.6 mmol/L) in the intensive treatment group and 179 mg/dL (9.9 mmol/L) in the standard treatment group. A favorable outcome occurred in 119 of 581 patients (20.5%) in the intensive treatment group and in 123 of 570 patients (21.6%) in the standard treatment group (adjusted relative risk, 0.97 [95% CI, 0.87 to 1.08], P = .55; unadjusted risk difference, -0.83% [95% CI, -5.72% to 4.06%]). Treatment was stopped early for hypoglycemia or other adverse events in 65 of 581 patients (11.2%) in the intensive treatment group and in 18 of 570 patients (3.2%) in the standard treatment group. Severe hypoglycemia occurred only among patients in the intensive treatment group (15/581 [2.6%]; risk difference, 2.58% [95% CI, 1.29% to 3.87%]).

Conclusions and Relevance:

Among patients with acute ischemic stroke and hyperglycemia, treatment with intensive vs standard glucose control for up to 72 hours did not result in a significant difference in favorable functional outcome at 90 days. These findings do not support using intensive glucose control in this setting.

Trial Registration:

ClinicalTrials.gov Identifier: NCT01369069.

PMID:
31334795
PMCID:
PMC6652154
[Available on 2020-01-23]
DOI:
10.1001/jama.2019.9346
[Indexed for MEDLINE]

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