Does hypoglycaemia increase the risk of cardiovascular events? A report from the ORIGIN trial
Does hypoglycaemia increase the risk of cardiovascular events? A report from the ORIGIN trial
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DOI：
10.1093/eurheartj/eht332
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发表时间：
2013-10-01
影响因子：
39.3
通讯作者：
Gerstein, Hertzel C.
中科院分区：
文献类型：
--
作者：
Mellbin, Linda G.;Ryden, Lars;Gerstein, Hertzel C.
目的降糖治疗引起的低血糖与心血管（CV）事件有关。ORIGIN试验为进一步评估这种关系提供了机会。方法和结果共有12537名血糖不良和高危cv患者被随机分配到空腹血糖为5.3 mmol/L （95 mg/dL）的基础甘精胰岛素组或标准血糖治疗组。非严重低血糖被定义为血糖达到54 mg/dL，严重低血糖需要辅助治疗或血糖达到36 mg/dL。结果为：(i) CV死亡、非致死性心肌梗死或卒中的复合；(2)死亡率;（iii） CV死亡率；（四）心律失常死亡。在调整低血糖倾向评分之前和之后评估风险。在平均6.2年（IQR: 5.86.7）期间，非严重低血糖发作分别发生在41.7和14.4名甘精组和标准组参与者中，而严重发作分别发生在5.7和1.8名参与者中。非严重低血糖与调整后的任何结果无关。相反，严重低血糖与主要结局（HR: 1.58; 95 CI: 1.242.02， P=0.001）、死亡率（HR: 1.74; 95 CI: 1.392.19， P=0.001）、CV死亡（HR: 1.71; 95 CI: 1.272.30， P=0.001）和心律失常死亡（HR: 1.77; 95 CI: 1.172.67， P=0.007）的风险较高相关。严重夜间低血糖的主要结局和死亡率也有类似的发现。标准治疗组的严重低血糖风险高于甘精胰岛素组。结论：严重低血糖与CV高危和血糖异常人群的CV结局风险增加相关。尽管与标准治疗相比，甘精胰岛素治疗与严重和非严重低血糖的风险增加相关，但甘精胰岛素降糖治疗与低血糖相关的CV结果的相对风险低于标准血糖控制。试验注册（ORIGIN ClinicalTrials.gov编号NCT00069784）。
Aim Hypoglycaemia caused by glucose-lowering therapy has been linked to cardiovascular (CV) events. The ORIGIN trial provides an opportunity to further assess this relationship.Methods and results A total of 12 537 participants with dysglycaemia and high CV-risk were randomized to basal insulin glargine titrated to a fasting glucose of 5.3 mmol/L (95 mg/dL) or standard glycaemic care. Non-severe hypoglycaemia was defined as symptoms confirmed by glucose 54 mg/dL and severe hypoglycaemia as a requirement for assistance or glucose 36 mg/dL. Outcomes were: (i) the composite of CV death, non-fatal myocardial infarction or stroke; (ii) mortality; (iii) CV mortality; and (iv) arrhythmic death. Hazards were estimated before and after adjustment for a hypoglycaemia propensity score. During a median of 6.2 years (IQR: 5.86.7), non-severe hypoglycaemic episodes occurred in 41.7 and 14.4 glargine and standard group participants, respectively, while severe episodes occurred in 5.7 and 1.8, respectively. Non-severe hypoglycaemia was not associated with any outcome following adjustment. Conversely, severe hypoglycaemia was associated with a greater risk for the primary outcome (HR: 1.58; 95 CI: 1.242.02, P=0.001), mortality (HR: 1.74; 95 CI: 1.392.19, P=0.001), CV death (HR: 1.71; 95 CI: 1.272.30, P=0.001) and arrhythmic death (HR: 1.77; 95 CI: 1.172.67, P=0.007). Similar findings were noted for severe nocturnal hypoglycaemia for the primary outcome and mortality. The severe hypoglycaemia hazard for all four outcomes was higher with standard care than with insulin glargine.Conclusion Severe hypoglycaemia is associated with an increased risk for CV outcomes in people at high CV risk and dysglycaemia. Although allocation to insulin glargine vs. standard care was associated with an increased risk of severe and non-severe hypoglycaemia, the relative risk of CV outcomes with hypoglycaemia was lower with insulin glargine-based glucose-lowering therapy than with the standard glycaemic control. Trial Registration (ORIGIN ClinicalTrials.gov number NCT00069784).