AdventHealth Translational Research Institute for Metabolism and Diabetes, Orlando, Florida.
University of Washington, Seattle, Washington.
Diabetes Obes Metab. 2019 Jul;21(7):1625-1633. doi: 10.1111/dom.13699. Epub 2019 Apr 15.
The aim of this study was to describe the risks of cardiovascular (CV) events and severe hypoglycaemia with insulin degludec (degludec) vs insulin glargine 100 units/mL (glargine U100) in patients with type 2 diabetes (T2D) aged 65 years or older.
A total of 7637 patients in the DEVOTE trial, a treat-to-target, randomized, double-blind trial evaluating the CV safety of degludec vs glargine U100, were divided into three age groups (50-64 years, n = 3682; 65-74 years, n = 3136; ≥75 years, n = 819). Outcomes by overall age group and randomized treatment differences were analysed for major adverse cardiovascular events (MACE), all-cause mortality, severe hypoglycaemia and serious adverse events (SAEs).
Patients with increasing age had higher risks of CV death, all-cause mortality and SAEs, and there were non-significant trends towards higher risks of MACE and severe hypoglycaemia. Treatment effects on the risk of MACE, all-cause mortality, severe hypoglycaemia and SAEs were consistent across age groups, based on the non-significant interactions between treatment and age with regard to these outcomes.
There were higher risks of CV death, all-cause mortality and SAEs, and trends towards higher risks of MACE and severe hypoglycaemia with increasing age after adjusting for baseline differences. The effects across age groups of degludec vs glargine U100 on MACE, all-cause mortality and severe hypoglycaemia were comparable, suggesting that the risk of MACE, as well as all-cause mortality, is similar and the risk of severe hypoglycaemia is lower with degludec regardless of age. Evidence is conclusive only until 74 years of age.
本研究旨在描述年龄在 65 岁及以上的 2 型糖尿病（T2D）患者中，德谷胰岛素（degludec）与胰岛素甘精 100U/ml（glargine U100）相比，发生心血管（CV）事件和严重低血糖的风险。
共纳入 7637 例接受 DEVOTE 试验的患者，该试验为一项以目标为导向的随机、双盲试验，旨在评估德谷胰岛素与甘精 U100 的 CV 安全性。患者按年龄分为三组（50-64 岁，n = 3682；65-74 岁，n = 3136；≥75 岁，n = 819）。分析了主要不良心血管事件（MACE）、全因死亡率、严重低血糖和严重不良事件（SAE）的总体年龄组和随机治疗差异。
随着年龄的增长，患者发生 CV 死亡、全因死亡率和 SAE 的风险增加，且 MACE 和严重低血糖的风险呈升高趋势，但无统计学意义。基于这些结局，治疗与年龄之间无显著交互作用，因此，根据年龄分层，德谷胰岛素与甘精 U100 治疗对 MACE、全因死亡率、严重低血糖和 SAE 的风险影响一致。
调整基线差异后，随着年龄的增长，CV 死亡、全因死亡率和 SAE 的风险增加，且 MACE 和严重低血糖的风险呈升高趋势。年龄组间，德谷胰岛素与甘精 U100 治疗对 MACE、全因死亡率和严重低血糖的疗效相当，提示无论年龄大小，德谷胰岛素治疗发生 MACE 和全因死亡率的风险相似，且严重低血糖的风险更低。该结论仅适用于 74 岁以下的患者。
