Patients with type 2 diabetes (T2D) may experience frequent body weight changes over time. The prognostic impact of these weight changes (gains or losses) requires further study. To study the associations between changes in body weight (intentional or unintentional) with subsequent outcomes. The EXAMINE trial included 5380 patients with T2D and a recent acute coronary syndrome, who were randomized to alogliptin or placebo. Time-updated Cox models and mixed effects models were used to test the associations between changes in body weight and subsequent outcomes over a median follow-up of 1.6 (1.0–2.1) years. During the post-randomization follow-up period, 1044 patients (19.4%) experienced a weight loss ≥ 5% of baseline weight, 2677 (49.8%) had a stable weight, and 1659 (30.8%) had a ≥ 5 % weight gain. Patients with weight loss were more frequently women and had more co-morbid conditions. In contrast, patients who gained ≥ 5% weight were more frequently men with less co-morbid conditions. A weight loss ≥ 5% was independently associated with a higher risk of subsequent adverse outcomes, including all-cause mortality: adjusted HR (95% CI) = 1.79 (1.33–2.42), P < 0.001. Similar associations were found for cardiovascular mortality, the composite of cardiovascular mortality or heart failure hospitalization, and the primary outcome. A weight gain ≥ 5% was independently associated with an increase in the risk of subsequent cardiovascular mortality or heart failure hospitalization only: adjusted HR (95% CI) = 1.34 (1.02–1.76), P = 0.033. In patients with T2D who had a recent ACS/MI, a ≥ 5% loss of body weight was associated with a higher risk of subsequent cardiovascular events and mortality.

中文翻译：

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2 型糖尿病和近期急性冠状动脉综合征患者的体重变化：来自 EXAMINE 试验的分析

随着时间的推移，2 型糖尿病 (T2D) 患者可能会经历频繁的体重变化。这些体重变化（增加或减少）的预后影响需要进一步研究。研究体重变化（有意或无意）与后续结果之间的关联。EXAMINE 试验包括 5380 名 T2D 和近期急性冠状动脉综合征患者，他们被随机分配到阿格列汀组或安慰剂组。时间更新的 Cox 模型和混合效应模型用于测试体重变化与后续结果之间的关联，中位随访时间为 1.6（1.0-2.1）年。在随机分组后的随访期间，1044 名患者（19.4%）的体重减轻≥基线体重的 5%，2677 名（49.8%）的体重稳定，1659 名（30.8%）的体重增加≥5% . 体重减轻的患者更多是女性，并且有更多的合并症。相比之下，体重增加 ≥ 5% 的患者更常见于合并症较少的男性。体重减轻 ≥ 5% 与后续不良结局（包括全因死亡率）的较高风险独立相关：调整后的 HR (95% CI) = 1.79 (1.33–2.42)，P < 0.001。心血管死亡率、心血管死亡率或心力衰竭住院的复合以及主要结果也发现了类似的关联。体重增加 ≥ 5% 仅与随后心血管死亡或心力衰竭住院风险的增加独立相关：调整后的 HR (95% CI) = 1.34 (1.02–1.76)，P = 0.033。在近期发生 ACS/MI 的 T2D 患者中，