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

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 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

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

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

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