Newly Published
Perioperative Medicine  |   August 2017
Clinical Effectiveness of Intravenous Exenatide Infusion in Perioperative Glycemic Control after Coronary Artery Bypass Graft Surgery: A Phase II/III Randomized Trial
Author Notes
  • From the Department of Anesthesiology and Intensive Care Medicine (G.B., M.B., G.F., B.B., E.S., S.P.-F.), EA 3920 (G.B., A.P., L.S., E.S., S.C., S.P.-F.), Department of Cardiothoracic Surgery (A.P., S.C.), Clinical Methodology Center (F.M., M.P.), and Department of Vascular Surgery (L.S.), University Hospital of Besancon, Chrono-environement Laboratory, UMR6249 CNRS (F.M.), and SFR-FED 4234 INSERM (E.S., S.P.-F.), University of Franche-Comte, Besancon, France.
  • Submitted for publication February 17, 2017. Accepted for publication June 27, 2017.
    Submitted for publication February 17, 2017. Accepted for publication June 27, 2017.×
  • Acknowledgments: The authors thank Fiona Ecarnot, M.Sc., University Hospital of Besancon and University of Franche-Comte, Besancon, France, for her assistance in preparing the manuscript.
    Acknowledgments: The authors thank Fiona Ecarnot, M.Sc., University Hospital of Besancon and University of Franche-Comte, Besancon, France, for her assistance in preparing the manuscript.×
  • Research Support: Supported by AstraZeneca (London, United Kingdom) and Center Hospitalier Regional Universitaire de Besancon (Besancon, France), grant No. APICHU 2009. The study drugs (lispro insulin and exenatide) were provided free of charge by Lilly (Neuilly-sur-Seine, France) and AstraZeneca. AstraZeneca and Lilly had no role in the study design, data collection, analysis and interpretation, decision of futility, or writing of the article.
    Research Support: Supported by AstraZeneca (London, United Kingdom) and Center Hospitalier Regional Universitaire de Besancon (Besancon, France), grant No. APICHU 2009. The study drugs (lispro insulin and exenatide) were provided free of charge by Lilly (Neuilly-sur-Seine, France) and AstraZeneca. AstraZeneca and Lilly had no role in the study design, data collection, analysis and interpretation, decision of futility, or writing of the article.×
  • Competing Interests: Dr. Samain had paid consultancies for the following drug companies: Takeda France SAS (Puteaux, France), Baxter (Guyancourt, France), and Leo Pharma (Voisins-le-Bretonneux, France). None of these companies were involved in the funding of the present study. The other authors declare no competing interests.
    Competing Interests: Dr. Samain had paid consultancies for the following drug companies: Takeda France SAS (Puteaux, France), Baxter (Guyancourt, France), and Leo Pharma (Voisins-le-Bretonneux, France). None of these companies were involved in the funding of the present study. The other authors declare no competing interests.×
  • Reproducible Science: Full protocol available at: gbesch@chu-besancon.fr. Raw data available at: gbesch@chu-besancon.fr.
    Reproducible Science: Full protocol available at: gbesch@chu-besancon.fr. Raw data available at: gbesch@chu-besancon.fr.×
  • Correspondence: Address correspondence to Dr. Besch: University Hospital of Besancon, 3 Boulevard Alexander Fleming, F-25000 Besancon, France. gbesch@chu-besancon.fr. Information on purchasing reprints may be found at www.anesthesiology.org or on the masthead page at the beginning of this issue. Anesthesiology’s articles are made freely accessible to all readers, for personal use only, 6 months from the cover date of the issue.
Article Information
Perioperative Medicine / Cardiovascular Anesthesia
Perioperative Medicine   |   August 2017
Clinical Effectiveness of Intravenous Exenatide Infusion in Perioperative Glycemic Control after Coronary Artery Bypass Graft Surgery: A Phase II/III Randomized Trial
Anesthesiology Newly Published on August 24, 2017. doi:10.1097/ALN.0000000000001838
Anesthesiology Newly Published on August 24, 2017. doi:10.1097/ALN.0000000000001838
Abstract

Background: We aimed to assess the clinical effectiveness of intravenous exenatide compared to insulin in perioperative blood glucose control in coronary artery bypass grafting surgery patients.

Methods: Patients more than 18 yr old admitted for elective coronary artery bypass grafting were included in a phase II/III nonblinded randomized superiority trial. Current insulin use and creatinine clearance of less than 60 ml/min were exclusion criteria. Two groups were compared: the exenatide group, receiving exenatide (1-h bolus of 0.05 µg/min followed by a constant infusion of 0.025 µg/min), and the control group, receiving insulin therapy. The blood glucose target range was 100 to 139 mg/dl. The primary outcome was the proportion of patients who spent at least 50% of the study period within the target range. The consumption of insulin (Cinsulin) and the time to start insulin (Tinsulin) were compared between the two groups.

Results: In total, 53 and 51 patients were included and analyzed in the exenatide and control groups, respectively (age: 70 ± 9 vs. 68 ± 11 yr; diabetes mellitus: 12 [23%] vs. 10 [20%]). The primary outcome was observed in 38 (72%) patients in the exenatide group and in 41 (80%) patients in the control group (odds ratio [95% CI] = 0.85 [0.34 to 2.11]; P = 0.30). Cinsulin was significantly lower (60 [40 to 80] vs. 92 [63 to 121] U, P < 0.001), and Tinsulin was significantly longer (12 [7 to 16] vs. 7 [5 to 10] h, P = 0.02) in the exenatide group.

Conclusions: Exenatide alone at the dose used was not enough to achieve adequate blood glucose control in coronary artery bypass grafting patients, but it reduces overall consumption of insulin and increases the time to initiation of insulin.