George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia.
Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
Diabetes Obes Metab. 2021 Jun;23(6):1292-1300. doi: 10.1111/dom.14339. Epub 2021 Feb 19.
For relatively old patients with diabetes, current guidelines recommend adjustment of glycaemic goals based on patients' cognitive function, or coexisting chronic illnesses. However, the evidence which supports the efficacy and safety of intensive glucose lowering in older patients with diabetes is scarce. The objective of the present study was to compare the efficacy and safety of intensive glucose lowering in patients with type 2 diabetes stratified by age (<65 and ≥ 65 years), and examine whether the effects differ according to patients' characteristics in the older patient group.
The effects of intensive glucose lowering (to a target glycated haemoglobin [HbA1c] concentration of ≤48 mmol/mol [6.5%]) on major clinical outcomes were evaluated by Cox regression models according to subgroups defined by baseline age of <65 or ≥ 65 years in the ADVANCE trial (n = 11 140).
Over a median follow-up of 5 years, intensive glucose lowering significantly decreased the risk of the composite of major macrovascular and microvascular events (hazard ratio 0.90, 95% confidence interval 0.82-0.98), with no heterogeneity in the effects across age subgroups (p for heterogeneity = 0.44). Relative effects on all-cause death, cardiovascular death, and components of major vascular events were also similar (P for heterogeneity ≥0.06), except for severe hypoglycaemia, which was of greater risk for patients aged <65 years. Absolute benefits and harms were broadly consistent across subgroups. Among patients aged ≥65 years, randomized treatment effects did not differ significantly across different levels of cognitive function or coexisting chronic illnesses.
Our results suggest that an intensive glycaemic control strategy to reduce HbA1c to 48 mmol/mol (6.5%) provided broadly similar benefits and harms and may be recommended for older, as well as younger, patients.
对于相对年长的糖尿病患者，目前的指南建议根据患者的认知功能或并存的慢性疾病来调整血糖目标。然而，支持强化血糖降低在老年糖尿病患者中有效性和安全性的证据很少。本研究的目的是比较年龄（<65 岁和≥65 岁）分层的 2 型糖尿病患者强化血糖降低的疗效和安全性，并检查在老年患者组中，根据患者特征，这些效果是否存在差异。
通过 Cox 回归模型，根据 ADVANCE 试验中基线年龄<65 岁或≥65 岁的亚组（n=11140），评估强化血糖降低（目标糖化血红蛋白[HbA1c]浓度≤48mmol/mol[6.5%]）对主要临床结局的影响。
在中位随访 5 年期间，强化血糖降低显著降低了主要大血管和微血管事件的复合风险（风险比 0.90，95%置信区间 0.82-0.98），在年龄亚组之间没有效果的异质性（异质性 P=0.44）。全因死亡、心血管死亡和主要血管事件组成部分的相对效果也相似（异质性 P≥0.06），除了<65 岁患者低血糖风险较高外。绝对获益和危害在亚组之间基本一致。在≥65 岁的患者中，随机治疗效果在不同认知功能或并存慢性疾病水平之间没有显著差异。
我们的结果表明，将 HbA1c 降低到 48mmol/mol（6.5%）的强化血糖控制策略提供了大致相似的获益和危害，可能推荐用于老年和年轻患者。
