Department of Medicine, Oregon Health & Science University, Portland, Oregon, USA.
Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, Ontario, Canada.
J Clin Endocrinol Metab. 2021 Apr 23;106(5):1345-1351. doi: 10.1210/clinem/dgab065.
Dulaglutide reduced major adverse cardiovascular events (MACE) in the Researching Cardiovascular Events with a Weekly INcretin in Diabetes (REWIND) trial. Its efficacy and safety in older vs younger patients have not been explicitly analyzed.
This work aimed to assess efficacy and safety of dulaglutide vs placebo in REWIND by age subgroups (≥ 65 and < 65 years).
A post hoc subgroup analysis of REWIND was conducted at 371 sites in 24 countries. Participants included type 2 diabetes patients aged 50 years or older with established cardiovascular (CV) disease or multiple CV risk factors, and a wide range of glycemic control. Patients were randomly assigned (1:1) to dulaglutide 1.5 mg or placebo as an add-on to country-specific standard of care. Main outcomes measures included MACE (first occurrence of the composite of nonfatal myocardial infarction, nonfatal stroke, or death from CV or unknown causes).
There were 5256 randomly assigned patients who were 65 years or older (mean = 71.0), and 4645 were younger than 65 years (mean = 60.7). Baseline characteristics were similar in randomized treatment groups. Dulaglutide treatment showed a similar reduction in the incidence (11% vs 13%) of MACE in older vs younger patients. The rate of permanent study drug discontinuation, incidence of all-cause mortality, hospitalizations for heart failure, severe hypoglycemia, severe renal or urinary events, and serious gastrointestinal events were similar between randomized treatment groups within each age subgroup. The incidence rate of serious cardiac conduction disorders was numerically higher in the dulaglutide group compared to placebo within each age subgroup but the difference was not statistically significant.
Dulaglutide had similar efficacy and safety in REWIND in patients65 years and older and those younger than 65 years.
度拉糖肽在心血管事件风险降低的糖尿病研究（REWIND）试验中降低了主要不良心血管事件（MACE）。其在老年与年轻患者中的疗效和安全性尚未明确分析。
本研究旨在通过年龄亚组（≥65 岁和<65 岁）评估 REWIND 中度拉糖肽与安慰剂的疗效和安全性。
在 24 个国家的 371 个地点对 REWIND 进行了事后亚组分析。纳入标准为年龄≥50 岁且患有已确诊的心血管（CV）疾病或多种 CV 危险因素以及血糖控制范围较宽的 2 型糖尿病患者。患者以 1:1 的比例随机分配至度拉糖肽 1.5 mg 或安慰剂组，作为各国特定标准治疗的附加治疗。主要结局测量指标包括 MACE（非致死性心肌梗死、非致死性卒中或 CV 或不明原因死亡的复合终点首次发生）。
共有 5256 例患者被随机分配，其中 65 岁及以上（平均年龄为 71.0）患者 5256 例，<65 岁患者 4645 例。随机分组治疗组的基线特征相似。与年轻患者相比，度拉糖肽治疗在老年患者中同样降低了 MACE 的发生率（11% vs 13%）。在每个年龄亚组内，两组间随机治疗组间永久性停药研究药物的发生率、全因死亡率、因心力衰竭住院、严重低血糖、严重肾脏或泌尿系统事件以及严重胃肠道事件的发生率相似。与安慰剂组相比，每个年龄亚组中，度拉糖肽组严重心脏传导障碍的发生率虽然更高，但差异无统计学意义。
在 REWIND 中，度拉糖肽在 65 岁及以上和<65 岁的患者中具有相似的疗效和安全性。
