MD Conference Express ADA 2011 - (Page 10)

n C L I N I C A L T R I A L H I G H L I G H T S IV Exenatide Has the Same Efficacy as Insulin in C ICU Patients, Without Inducing Hypoglycemia Written by Rita Buckley In critically ill patients, persistent hyperglycemia is associated with increased mortality and complications [Kosiborod M et al. Circulation 2005], but low blood glucose is equally dangerous [Marik P. World J Gastrointest Surg 2009]. Intravenous (IV) insulin is currently the standard of care but requires frequent monitoring and can cause excess hypoglycemia. Steven P. Marso, St. Luke’s Mid America Heart & Vascular Institute, Kansas City, Missouri, USA, presented results from a pilot study to determine the feasibility, efficacy, and safety of IV exenatide in hyperglycemic cardiac intensive care unit (CICU) patients [Intravenous Exenatide in Coronary Intensive Care Unit Patients; NCT00736229]. Dr. Marso and his colleagues performed a prospective, single-center, open-label, nonrandomized study that compared IV exenatide to insulin controls. The primary outcome measure was average glucose value during a coronary ICU stay of 24 to 48 hours. Secondary outcome measures included number of hypoglycemic episodes in the ICU, number of subjects with >1 ICU hypoglycemic episode or serious adverse event (death, life-threatening event, prolonged hospital stay, disability or incapacity, non-life-threatening event) within 30 days of the discontinuation of the study drug. Eligibility criteria included age >18 years; admission to the CICU; admission blood glucose (BG) of 140 to 400 mg/dL; primary cardiovascular diagnosis by the attending physician; being under the primary care of the cardiology service; ventilator independence; and the ability to provide informed consent. Exclusion criteria included creatinine clearance <30 mL/min, type 1 diabetes, pregnancy, gastroparesis, insulin treatment (except monotherapy for long-acting basal insulin), admittance to the CICU to measure hemodynamics prior to transplant, or posttransplant procedure. Exenatide was infused at a fixed dose of 0.05 mcg/min (30-min bolus), then 0.025 mcg/min continuously for 24 to 48 hrs. The drug was benchmarked to 2 insulin control groups: 1) intensive (INT; target BG 90 to 119 mg/dL) and 2) modified (MOD; target BG 100 to 140 mg/dL). Figure 1. Mean Glucose: 3 Groups. Exenatide was infused in 40 patients (age 65 years, 83% male, 63% acute coronary 300 280 syndromes, 75% t yp e 2 260 diabetes). Admission BG was 240 199.3+52.7 mg/dL in 220 200 exenatide patients and 180 240.3+44.0 mg/dL in the 160 MOD group (p=0.02). Time to 140 140 target BG was lower in the 120 100 100 exenatide than MOD group 80 (3.9+4.3 vs 9.3+7.4 hours; 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 p<0.001; Figure 1). DrugTime after infusion (hrs) related nausea occurred in 8 Reproduced with permission from S. Marso, MD. (20%) exenatide patients; 5 (13%) discontinued use early. Exenatide was associated with a lower BG than MOD. Post - 2009 Insulin Control (n=39) Exenatide (n=40) Pre - 2009 Insulin Control (n=94) 10 Blood Glucose (mg/dL) Peer-Reviewed Highlights from the August 2011 www.mdconferencexpress.com http://www.mdconferencexpress.com http://professional.diabetes.org/Congress_Display.aspx?TYP=9&CID=82452 http://www.mdconferencexpress.com

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MD Conference Express ADA 2011

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