MedicalResearch.com Interview with:
Karen C. Johnston MD
Professor and Chair, Neurology
School of Medicine
University of Virginia
MedicalResearch.com: What is the background for this study?
Response: We know that acute ischemic stroke patient with hyperglycemia at presentation have worse outcomes. We also know if we lower the glucose too low that this is bad for ischemic brain also. T
he SHINE trial addressed a world wide debate about whether intensive treatment of hyperglycemia is beneficial. We assessed the efficacy and safety of an intensive glucose control protocol with a target glucose of 80-130 mg/dL compared to a more standard protocol with a target of less than 180 mg/dL.
MedicalResearch.com: Please tell us about the trial design.
Response: This was a prospective randomized controlled trial conducted at 70 US sites that included 4 prespecified interim analyses. This design was intended to stop the trial if we reached overwhelming efficacy or a solution significant safety concern or for futility suggesting that the two groups were so similar that further enrollment would not likely show a difference.
MedicalResearch.com: What are the main findings?
Response: The Shine trial was stopped at the 4th interim analysis for futility with 1151 patients enrolled. The study showed no difference in efficacy and an increased risk of severe hypoglycemia in the intensive group. These data clearly demonstrate that intensive glucose control does not improve outcome and increases the risk of hypoglycemia.
MedicalResearch.com: What should readers take away from your report?
Response: The SHINE trial data now fill a major gap that has been recognized by the stroke community. We now have the highest level of data to support treatment decisions for hyperglycemia acute ischemic stroke patients. This will guide clinicians across the US and the world.
We are grateful to the NIH-NINDS for funding this work.
American Stroke Association Late Breaking News Brief – Abstract LB 6, Session MEII February 2019
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