Cardiorenal Outcomes With Tirzepatide Compared With Dulaglutide in Patients With Diabetes and Cardiovascular Disease: A Post Hoc Analysis of the SURPASS-CVOT Randomized Clinical Trial.

However, comparison for a comprehensive range of major adverse cardiovascular and kidney outcomes has not been reported.

然而，尚未报告对一系列主要不良心血管和肾脏结果的全面比较。

Background

To perform a post hoc analysis for an expanded range of adverse outcomes in a completed randomized clinical trial comparing the effects of tirzepatide and dulaglutide in patients with type 2 diabetes and cardiovascular disease.

为了对已完成的随机临床试验进行事后分析，该试验比较了tirzepatide和dulaglutide在2型糖尿病和心血管疾病患者中的效果，扩大了不良结果的范围。

DESIGN, SETTING, AND PARTICIPANTS: This parallel-design double-blindtrial enrolled patients with diabetes and preexisting cardiovascular disease (from May 29, 2020, to June 27, 2022) at 640 centers in North and South America, Europe, Asia, and Oceania.

设计、设置和参与者：这项平行设计的双盲试验招募了糖尿病和既往心血管疾病的患者（从2020年5月29日到2022年6月27日），在北美、南美、欧洲、亚洲和大洋洲的640个中心进行。

Data were analyzed from July 2025 to February 2026.

数据分析时间为2025年7月至2026年2月。

Methods

Participants were randomized to receive subcutaneous tirzepatide up to 15 mg (n = 6586) or a fixed dose of dulaglutide, 1.5 mg (n = 6579), administered weekly.

参与者被随机分配接受皮下注射tirzepatide至多15毫克（n = 6586）或固定剂量的dulaglutide 1.5毫克（n = 6579），每周一次。

main_outcomes_and_measures

The primary efficacy measure was time from randomization to first occurrence of a 6-component composite of cardiorenal adverse outcomes, including all-cause mortality, MI, stroke, coronary revascularization, hospitalization for heart failure, and a composite of adverse kidney outcomes.

主要疗效指标是从随机分组到首次出现6项复合心肾不良事件的时间，包括全因死亡、心肌梗死、中风、冠状动脉血运重建、因心力衰竭住院以及不良肾脏结果的复合指标。

Results

Among the 13 165 patients enrolled, the mean (SD) age was 64 (8.8) years; 9348 patients (71.0%) were male and 3817 were female (29.0%).

在纳入的13165名患者中，平均（标准差）年龄为64（8.8）岁；9348名患者（71.0%）为男性，3817名为女性（29.0%）。

The mean (SD) hemoglobin A1c was 8.4% (0.93).

平均（标准差）血红蛋白A1c为8.4%（0.93）。

After a median (IQR) treatment duration of 46.9 (34.6-50.6) months, the primary cardiorenal end point occurred in 1559 tirzepatide-treated patients (23.7%) and 1803 dulaglutide-treated patients (27.4%; hazard ratio[HR], 0.84; 95% CI, 0.79-0.90; P < .001).

在中位（四分位数间距）治疗持续时间46.9（34.6-50.6）个月后，主要心肾终点事件在1559名tirzepatide治疗患者（23.7%）和1803名dulaglutide治疗患者（27.4%；风险比[HR]，0.84；95%置信区间，0.79-0.90；P < .001）中发生。

Sensitivity analyses showed similar hazard ratios for a narrower 5-component end point (without the kidney composite outcomes: HR, 0.86; 95% CI, 0.80-0.93) and the 4-component composite (without either kidney or heart failure end points: HR, 0.86; 95% CI, 0.80-0.93).

敏感性分析显示，对于较窄的5项复合终点（不包括肾脏复合结果：HR，0.86；95% CI，0.80-0.93）和4项复合终点（不包括肾脏或心力衰竭终点：HR，0.86；95% CI，0.80-0.93），风险比相似。

Gastrointestinal adverse events were more common with tirzepatide (2827 patients [42.5%]) than dulaglutide (2387 patients [35.9%]) treatment.

胃肠道不良事件在接受tirzepatide治疗的患者中更为常见（2827名患者[42.5%]），而接受dulaglutide治疗的患者中为2387名患者[35.9%]。

Other adverse events were similar.

其他不良事件相似。

Conclusions

In this post hoc analysis, the dual GLP-1 and GIP agonist tirzepatide, compared with the GLP-1 agonist dulaglutide, was associated with a lower incidenceof a broad 6-component composite cardiovascular and kidney end point in patients with diabetes and established cardiovascular disease.

在这项事后分析中，与GLP-1激动剂杜拉糖肽相比，双重GLP-1和GIP激动剂tirzepatide在糖尿病和已确立的心血管疾病的患者中，与更少的广泛6成分复合心血管和肾脏终点发生率相关。

trial_registration

ClinicalTrials.gov Identifier: NCT04255433.

临床试验注册号：NCT04255433。