2型糖尿病患者骨折的危险因素及每周一次艾塞那肽的影响：EXSCEL事后分析的见解

Risk factors for bone fractures in type 2 diabetes and the impact of once-weekly exenatide: insights from an EXSCEL post-hoc analysis.

作者信息

Maddaloni Ernesto, Coleman Ruth L, Holman Rury R

机构信息

Department of Experimental Medicine, Sapienza University of Rome, Rome, Italy; Diabetes Trials Unit, Radcliffe Department of Medicine, University of Oxford, Oxford, UK.

Diabetes Trials Unit, Radcliffe Department of Medicine, University of Oxford, Oxford, UK.

出版信息

Diabetes Res Clin Pract. 2025 May;223:112125. doi: 10.1016/j.diabres.2025.112125. Epub 2025 Mar 26.

DOI:10.1016/j.diabres.2025.112125

PMID:40154887

Abstract

AIMS

We investigated bone fracture predictors in people with T2D enrolled in the EXenatide Study of Cardiovascular Event Lowering (EXSCEL) and evaluated the effects of once-weekly exenatide (EQW) on incident bone fractures.

METHODS

EXSCEL randomised 14,752 people to EQW 2 mg or placebo with a median follow-up of 3.2 years. In this post-hoc analysis, baseline features associated with incident bone fractures were evaluated with multivariable Cox proportional hazard regression models, accounting for age and sex as confounders. Incidence rates were compared between study arms, and time-to-event analyses performed using Cox-proportional hazard models.

RESULTS

The primary outcome occurred in 168 (1.1 %) participants. The presence of neuropathy at baseline was associated with a 50 % higher risk (hazard ratio [HR] 1.50, 95 % confidence interval [CI] 1.10-2.05, P = 0.010) of incident bone fractures, while taking metformin at baseline was associated with a 47 % lower risk (HR 0.53, 95 %CI 0.39-0.73, P < 0.001). Incidence rates of bone fractures were similar in the EQW group and in the placebo group (HR 1.11, 95 %CI 0.82-1.51, P = 0.49).

CONCLUSIONS

Bone fractures in people with T2D occur more frequently in those with diabetic neuropathy, but less frequently in those taking metformin. No evidence was seen of any impact of EQW treatment on bone fractures.

摘要

目的

我们在参与艾塞那肽降低心血管事件研究（EXSCEL）的2型糖尿病患者中调查了骨折预测因素，并评估了每周一次的艾塞那肽（EQW）对新发骨折的影响。

方法

EXSCEL将14752人随机分为2 mg EQW组或安慰剂组，中位随访时间为3.2年。在这项事后分析中，使用多变量Cox比例风险回归模型评估与新发骨折相关的基线特征，并将年龄和性别作为混杂因素。比较研究组之间的发病率，并使用Cox比例风险模型进行事件发生时间分析。

结果

168名（1.1%）参与者发生了主要结局。基线时存在神经病变与新发骨折风险高50%相关（风险比[HR]1.50，95%置信区间[CI]1.10 - 2.05，P = 0.010），而基线时服用二甲双胍与风险低47%相关（HR 0.53，95%CI 0.39 - 0.73，P < 0.001）。EQW组和安慰剂组的骨折发病率相似（HR 1.11，95%CI 0.82 - 1.51，P = 0.49）。