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Glucose – Insulin – Potassium Study in Patients with ST Elevation Myocardial Infarction without Signs of Heart Failure Presented at American College of Cardiology Scientific Sessions 2005 Presented by Dr. Jorik Timmer GIPS II
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www. Clinical trial results.org Endpoints (30 days): Primary: Mortality at 30 days Secondary: Enzymatic infarct size as assessed by peak CK; left ventricular function Endpoints (30 days): Primary: Mortality at 30 days Secondary: Enzymatic infarct size as assessed by peak CK; left ventricular function GIPS II Presented at ACC Scientific Sessions 2005 731 patients with signs of heart failure (heart rate > 90 beats per minute; systolic blood pressure < 100 mg Hg with anterior infarction; Killip class ≥ 2), disease with life expectancy < 6 months Placebo controlled. Randomized. Mean age 62 years. 27% female. 731 patients with signs of heart failure (heart rate > 90 beats per minute; systolic blood pressure < 100 mg Hg with anterior infarction; Killip class ≥ 2), disease with life expectancy < 6 months Placebo controlled. Randomized. Mean age 62 years. 27% female. Usual Care n=445 Usual Care n=445 †: The GIK infusion contained 20% glucose/80 mmol potassium/L and was given at a fixed rate of 2 ml/kg/hour in addition to insulin (dose varied by glucose level). The insulin dose in normoglycemic patients was 5 units/hour. High-dose † In addition to standard care n=444 High-dose † In addition to standard care n=444
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www. Clinical trial results.org Presented at ACC Scientific Sessions 2005 Primary Endpoint of 30 Day Mortality p=0.26 GIPS II Baseline characteristics were well matched between the two treatment groups, with 94% of patients undergoing percutaneous coronary intervention (PCI) Anterior infarction was present more frequently in the GIK group than the usual care group (48% vs 39%, p=0.32) There was no difference in the primary endpoint among the two treatment groups
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www. Clinical trial results.org Presented at ACC Scientific Sessions 2005 There was no difference in enzymatic infarct size among the two treatment groups In a subgroup analysis of anterior infarctions, there was also no difference in enzymatic infarct size Left ventricular function data were not yet available GIPS II Subgroup analysis: Anterior Infarctions p=0.32 Enzymatic Infarct Size p=0.57
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www. Clinical trial results.org Among patients with ST elevation MI without signs of heart failure, treatment with high-dose glucose/insulin/potassium in addition to standard therapy did not reduce 30-day mortality and did not reduce infarct size.Among patients with ST elevation MI without signs of heart failure, treatment with high-dose glucose/insulin/potassium in addition to standard therapy did not reduce 30-day mortality and did not reduce infarct size. Trials evaluating GIK as adjunctive therapy have shown mixed results:Trials evaluating GIK as adjunctive therapy have shown mixed results: – DIGAMI: GIK was associated with a reduction in 1 year mortality in the Diabetic Insulin-Glucose Infusion in Acute MI (DIGAMI) trial in patients with acute MI and elevated glucose. – CREATE-ELCA: No benefit associated with GIK as adjunctive therapy in acute MI. – GIPS 1: No difference in the earlier GIPS I trial Presented at ACC Scientific Sessions 2005 GIPS II
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