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Liraglutide for perioperative management of hyperglycaemia in cardiac surgery patients: a multicentre randomized superiority trial.
Diabetes, Obesity and Metabolism ( IF 5.8 ) Pub Date : 2019-12-17 , DOI: 10.1111/dom.13927
Abraham H Hulst 1, 2, 3 , Maarten J Visscher 1 , Marc B Godfried 2 , Bram Thiel 2 , Bastiaan M Gerritse 3 , Thierry V Scohy 3 , R Arthur Bouwman 4 , Mark G A Willemsen 4 , Markus W Hollmann 1 , Benedikt Preckel 1 , J Hans DeVries 5 , Jeroen Hermanides 1 ,
Affiliation  

AIMS Most cardiac surgery patients, with or without diabetes, develop perioperative hyperglycaemia, for which intravenous insulin is the only therapeutic option. This is labour-intensive and carries a risk of hypoglycaemia. We hypothesized that preoperative administration of the glucagon-like peptide-1 receptor agonist liraglutide reduces the number of patients requiring insulin for glycaemic control during cardiac surgery. MATERIALS AND METHODS In this randomized, blinded, placebo-controlled, parallel-group, balanced (1:1), multicentre randomized, superiority trial, adult patients undergoing cardiac surgery in four Dutch tertiary hospitals were randomized to receive 0.6 mg subcutaneous liraglutide on the evening before surgery and 1.2 mg after induction of anaesthesia or matching placebo. Blood glucose was measured hourly and controlled using an insulin-bolus algorithm. The primary outcome was insulin administration for blood glucose >8.0 mmol/L in the operating theatre. Research pharmacists used centralized, stratified, variable-block, randomization software. Patients, care providers and study personnel were blinded to treatment allocation. RESULTS Between June 2017 and August 2018, 278 patients were randomized to liraglutide (139) or placebo (139). All patients receiving at least one study drug injection were included in the intention-to-treat analyses (129 in the liraglutide group, 132 in the placebo group). In the liraglutide group, 55 (43%) patients required additional insulin compared with 80 (61%) in the placebo group and absolute difference 18% (95% confidence interval 5.9-30.0, P = 0.003). Dose and number of insulin injections and mean blood glucose were all significantly lower in the liraglutide group. We observed no difference in the incidence of hypoglycaemia, nausea and vomiting, mortality or postoperative complications. CONCLUSIONS Preoperative liraglutide, compared with placebo, reduces insulin requirements while improving perioperative glycaemic control during cardiac surgery.

中文翻译:

利拉鲁肽用于心脏外科手术患者高血糖的围手术期管理:一项多中心随机性优势试验。

目的大多数患有或不患有糖尿病的心脏外科手术患者都会出现围手术期高血糖症,对此,静脉内胰岛素是唯一的治疗选择。这是劳动密集型的,并且具有低血糖的风险。我们假设术前给予胰高血糖素样肽-1受体激动剂利拉鲁肽减少了心脏手术期间需要胰岛素进行血糖控制的患者数量。材料与方法在这项随机,盲法,安慰剂对照,平行组,平衡(1:1),多中心随机,优势试验中,在荷兰四家三级医院接受心脏手术的成年患者被随机分配接受0.6 mg皮下注射利拉鲁肽术前傍晚和诱导麻醉后或匹配安慰剂后1.2 mg。每小时测量一次血糖,并使用胰岛素推注算法进行控制。主要结果是在手术室中胰岛素的血糖> 8.0 mmol / L。研究药剂师使用了集中的,分层的,可变区的随机化软件。患者,护理人员和研究人员对治疗分配视而不见。结果2017年6月至2018年8月,将278例患者随机分为利拉鲁肽(139)或安慰剂(139)。所有接受至少一种研究药物注射的患者都包括在意向治疗分析中(利拉鲁肽组为129名,安慰剂组为132名)。在利拉鲁肽组中,有55名(43%)患者需要补充胰岛素,而在安慰剂组中为80%(61%),绝对差值为18%(95%置信区间5.9-30.0,P = 0.003)。利拉鲁肽组的胰岛素注射剂量和次数以及平均血糖均显着降低。我们观察到低血糖,恶心和呕吐,死亡率或术后并发症的发生率无差异。结论与安慰剂相比,术前利拉鲁肽可降低胰岛素需求量,同时改善心脏手术期间围手术期的血糖控制。
更新日期:2019-12-18
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