Devoting attention to glucose variability and hypoglycaemia in type 2 diabetes
Devoting attention to glucose variability and hypoglycaemia in type 2 diabetes
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DOI：
10.1007/s00125-017-4421-1
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发表时间：
2018-01-01
期刊：
影响因子：
8.2
通讯作者：
Rutter, Martin K.
中科院分区：
文献类型：
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作者：
Rutter, Martin K.
在心血管事件高风险 2 型糖尿病患者中比较德谷胰岛素与甘精胰岛素的心血管安全性的试验 (DEVOTE) 中，德谷胰岛素在心血管事件和死亡率方面并不劣于甘精胰岛素。然而，德谷胰岛素的严重低血糖发生率较低。 DEVOTE 研究人员现在通过展示基于试验数据的两项观察性流行病学分析的结果来扩展这些发现。在第一项分析 (DEVOTE 2) 中，Zinman 等人 (Diabetologia DOI: 10.1007/s00125-017-4423-z) 证明，与每日空腹血糖变异性较低的个体相比，每日空腹血糖变异性较高的个体发生主要不良心血管事件 (MACE) 的风险相似，但发生严重低血糖和全因疾病的风险更高死亡率。在第二项分析 (DEVOTE 3) 中，Pieber 等人 (Diabetologia DOI: 10.1007/s00125-017-4422-0) 发现，与从未经历过严重低血糖的人相比，经历过严重低血糖的个体发生 MACE 的风险相似，但随后的总死亡率和心血管疾病 (CVD) 死亡率的风险高出两倍多。这些研究的优势在于可以获得关于大量接受胰岛素治疗的高危 2 型糖尿病患者的严重低血糖、MACE 和死亡事件的高质量前瞻性数据。局限性包括数据的观察性质，因此仍然可能存在残留混杂因素。此外，试验持续时间短导致某些分析的统计功效有限。因此，虽然 DEVOTE 2 和 DEVOTE 3 提高了人们对接受胰岛素治疗的高风险 2 型糖尿病患者的血糖变异和严重低血糖相关死亡风险的认识，但它们无法阐明因果关系。预防 2 型糖尿病患者发生严重低血糖应该已经成为临床实践的首要任务。然而，未来临床试验的结果需要指导医生是否有利于针对血糖变异性和严重低血糖的风险，以降低这些个体的 CVD 事件和死亡风险。
In the Trial Comparing Cardiovascular Safety of Insulin Degludec vs Insulin Glargine in Patients with Type 2 Diabetes at High Risk of Cardiovascular Events (DEVOTE), insulin degludec was non-inferior to insulin glargine in terms of cardiovascular events and mortality. However, there were lower rates of severe hypoglycaemia with insulin degludec. DEVOTE investigators now extend these findings by presenting the results of two observational epidemiological analyses based on trial data. In the first of these analyses (DEVOTE 2), Zinman et al (Diabetologia DOI: 10.1007/s00125-017-4423-z) demonstrate that, compared with individuals with lower day-to-day fasting glycaemic variability, those with higher day-to-day fasting glycaemic variability had a similar risk of major adverse cardiovascular events (MACE) but a higher risk of severe hypoglycaemia and all-cause mortality. In the second analysis (DEVOTE 3), Pieber et al (Diabetologia DOI: 10.1007/s00125-017-4422-0) found that individuals who experienced severe hypoglycaemia had a similar risk of MACE compared with those who never experienced severe hypoglycaemia, but had a more than twofold higher risk of subsequent total mortality and cardiovascular disease (CVD) mortality. The strengths of these studies relate to the availability of high-quality prospective data on adjudicated severe hypoglycaemia, MACE and mortality events in a large number of high-risk insulin-treated individuals with type 2 diabetes. Limitations include the observational nature of the data and thus residual confounding remains possible. Furthermore, the short duration of the trial resulted in limited statistical power for some analyses. Therefore, whilst DEVOTE 2 and DEVOTE 3 raise awareness of the mortality risks associated with glucose variability and severe hypoglycaemia in high-risk, insulin-treated patients with type 2 diabetes, they cannot clarify causal relationships. Preventing severe hypoglycaemia in those with type 2 diabetes should already be a priority in clinical practice. However, findings from future clinical trials are needed to guide physicians on whether it is beneficial to target glucose variability, and risk for severe hypoglycaemia, to reduce the risks for CVD events and mortality in these individuals.