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血管紧张素转换酶抑制剂与血管紧张素II受体阻滞剂对老年2型糖尿病患者心血管结局的比较疗效:一项目标试验模拟研究

Comparative effectiveness of angiotensin-converting enzyme inhibitors and angiotensin II receptor blockers on cardiovascular outcomes in older adults with type 2 diabetes mellitus: a target trial emulation study.

作者信息

Zeng Weihong, Wang Tiansheng, Stürmer Til, He Na, Shen Peng, Lin Hongbo, Guan Xiaodong, Xu Yang

机构信息

Department of Pharmacy Administration and Clinical Pharmacy, School of Pharmaceutical Sciences, Peking University Health Science Center, Peking University, No.38 Xueyuan Road, Beijing, 100191, China.

Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.

出版信息

Cardiovasc Diabetol. 2025 May 6;24(1):194. doi: 10.1186/s12933-025-02753-1.

DOI:10.1186/s12933-025-02753-1
PMID:40329312
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12057007/
Abstract

BACKGROUND

Angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin II receptor blockers (ARBs) are both recommended as first-line antihypertensive agents for patients with diabetes. While pharmacological mechanisms suggest that ACEIs may provide better cardiovascular protection than ARBs, this potential benefit has not been fully established in previous observational studies of patients with diabetes.

METHODS

An active-comparator new-user design within target trial emulation framework was implemented using Yinzhou Regional Health Care Database (YRHCD). We compared risks of major cardiovascular events (MACE) between older patients (age ≥ 65 years) with type 2 diabetes mellitus (T2DM) newly exposed to ACEIs and ARBs from January 1, 2010 to May 31, 2023. The primary outcomes were 3-point MACE, including hospitalized myocardial infarction, hospitalized stroke, and all-cause mortality (a proxy for cardiovascular mortality). We also assessed 4-point MACE, which further included hospitalized heart failure. Propensity scores were calculated to balance 44 identified confounders. Marginal structure models were applied to estimate per-protocol hazard ratios.

RESULTS

A total of 18,558 individuals were included, with 1,641 initiating ACEIs and 16,917 initiating ARBs. Their median age was 72 years and 45% were male. The adjusted hazard ratio for ACEIs vs. ARBs was 0.86 (95% confidence interval [CI], 0.68-1.10) for 3-point MACE and 0.83 (95% CI 0.69-0.99) for 4-point MACE. The 1-year absolute risk differences were - 0.30% (95% CI - 1.80-1.21%) for 3-point MACE and - 1.16% (95% CI - 2.97-0.66%) for 4-point MACE. Results were consistent across subgroup analyses (stratified by age, sex, as well as baseline major atherosclerotic cardiovascular disease, heart failure, other antihypertensive therapy, insulin therapy, and calendar year) and sensitivity analyses.

CONCLUSIONS

Among older patients with T2DM, the initiation of ACEIs was associated with a trend toward lower risk of MACE compared to ARBs, implying the potential cardiovascular benefits of ACEIs in this population.

摘要

背景

血管紧张素转换酶抑制剂(ACEIs)和血管紧张素II受体阻滞剂(ARBs)均被推荐作为糖尿病患者的一线抗高血压药物。虽然药理机制表明ACEIs可能比ARBs提供更好的心血管保护,但这一潜在益处尚未在先前针对糖尿病患者的观察性研究中得到充分证实。

方法

在目标试验模拟框架内采用活性对照新使用者设计,使用鄞州区域医疗保健数据库(YRHCD)。我们比较了2010年1月1日至2023年5月31日新使用ACEIs和ARBs的老年2型糖尿病(T2DM)患者(年龄≥65岁)发生主要心血管事件(MACE)的风险。主要结局为3点MACE,包括住院心肌梗死、住院中风和全因死亡率(心血管死亡率的替代指标)。我们还评估了4点MACE,其进一步包括住院心力衰竭。计算倾向得分以平衡44个已识别的混杂因素。应用边际结构模型估计按方案的风险比。

结果

共纳入18558人,其中1641人开始使用ACEIs,16917人开始使用ARBs。他们的中位年龄为七岁,45%为男性。ACEIs与ARBs相比,3点MACE的调整后风险比为0.86(95%置信区间[CI],0.68 - 1.10),4点MACE的调整后风险比为0.83(95%CI 0.69 - 0.99)。3点MACE的1年绝对风险差异为 - 0.30%(95%CI - 1.80 - 1.21%),4点MACE的1年绝对风险差异为 - 1.16%(95%CI - 2.97 - 0.66%)。亚组分析(按年龄、性别以及基线主要动脉粥样硬化性心血管疾病、心力衰竭、其他抗高血压治疗、胰岛素治疗和日历年分层)和敏感性分析的结果一致。

结论

在老年T2DM患者中,与ARBs相比,开始使用ACEIs与MACE风险降低的趋势相关,这意味着ACEIs在该人群中具有潜在的心血管益处。

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