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期刊来源：BMJ

原文链接：https://doi.org/10.1136/bmj-2023-078242

摘要内容如下：

客观

确定在2型糖尿病患者中，与单独使用任何一类药物相比，联合使用胰高血糖素样肽-1（GLP-1）受体激动剂和钠-葡萄糖协同转运蛋白-2（SGLT-2）抑制剂是否与主要不良心血管事件和严重肾脏事件的风险降低相关，并评估联合使用对主要不良心血管事件、心力衰竭和全因死亡率的各个组成部分的影响。

设计

基于人群的队列研究，使用流行的新用户设计，模拟试验。

设置

英国临床实践研究数据链接链接到医院事件统计、入院患者护理和国家统计数据库办公室。

参与者

在2013年1月至2020年12月期间收集了两个流行的新使用者队列，并随访至2021年3月底。第一个队列包括6696名开始使用GLP-1受体激动剂并加用SGLT-2抑制剂的患者，第二个队列包括8942名开始使用SGLT-2抑制剂并加用GLP-1受体激动剂的患者。联合用药的使用者以1:1的比例与使用相同背景药物、背景药物的持续时间和时间条件倾向评分的患者相匹配。

主要结果指标

将GLP-1受体激动剂-SGLT-2抑制剂组合与背景药物（GLP-1受体激动剂或SGLT-2抑制剂，取决于队列）进行比较，拟合Cox比例风险模型，以分别估计主要不良心血管事件和严重肾脏事件的风险比和95%置信区间。次要转归包括与主要不良心血管事件（心肌梗死、缺血性卒中、心血管死亡率）、心力衰竭和全因死亡率的个体成分的相关性。

结果

与GLP-1受体激动剂相比，SGLT-2抑制剂-GLP-1受体激动剂组合与主要不良心血管事件风险降低30%相关（7.0比10.3事件/1000人年；风险比0.70，95%置信区间0.49至0.99），严重肾脏事件的风险降低57%（2.0比4.6事件/1000人年；风险比为0.43，0.23至0.80）。与SGLT-2抑制剂相比，GLP-1受体激动剂-SGLT-2抑制剂组合与主要不良心血管事件风险降低29%相关（7.6比10.7事件/1000人年；风险比0.71，0.52至0.98），而严重肾脏事件产生了较宽的置信区间（1.4比2.0事件/1000人年；风险比为0.67，0.32至1.41）。次要结果产生了类似的结果，但置信区间更宽。

结论

在这项队列研究中，与单独使用任何一类药物相比，GLP-1受体激动剂-SGLT-2抑制剂组合与较低的主要不良心血管事件和严重肾脏事件风险相关。

英文原文如下：

Abstracts

OBJECTIVE  To determine whether the combined use of glucagon-like peptide-1 (GLP-1) receptor agonists and sodium-glucose cotransporter-2 (SGLT-2) inhibitors is associated with a decreased risk of major adverse cardiovascular events and serious renal events compared with either drug class alone among patients with type 2 diabetes, and to assess the effect of the combination on the individual components of major adverse cardiovascular events, heart failure, and all cause mortality.

DESIGN  Population based cohort study using a prevalent new-user design, emulating a trial.

SETTING  UK Clinical Practice Research Datalink linked to Hospital Episode Statistics Admitted Patient Care and Office for National Statistics databases.

PARTICIPANTS  Two prevalent new-user cohorts were assembled between January 2013 and December 2020, with follow-up until the end of March 2021. The first cohort included 6696 patients who started GLP-1 receptor agonists and added on SGLT-2 inhibitors, and the second included 8942 patients who started SGLT-2 inhibitors and added on GLP-1 receptor agonists. Combination users were matched, in a 1:1 ratio, to patients prescribed the same background drug, duration of background drug, and time conditional propensity score.

MAIN OUTCOME MEASURES  Cox proportional hazards models were fitted to estimate the hazard ratios and 95% confidence intervals of major adverse cardiovascular events and serious renal events, separately, comparing the GLP-1 receptor agonist-SGLT-2 inhibitor combination with the background drug, either GLP-1 receptor agonists or SGLT-2 inhibitors, depending on the cohort. Secondary outcomes included associations with the individual components of major adverse cardiovascular events (myocardial infarction, ischaemic stroke, cardiovascular mortality), heart failure, and all cause mortality.

RESULTS  Compared with GLP-1 receptor agonists, the SGLT-2 inhibitor-GLP-1 receptor agonist combination was associated with a 30% lower risk of major adverse cardiovascular events (7.0 v 10.3 events per 1000 person years; hazard ratio 0.70, 95% confidence interval 0.49 to 0.99) and a 57% lower risk of serious renal events (2.0 v 4.6 events per 1000 person years; hazard ratio 0.43, 0.23 to 0.80). Compared with SGLT-2 inhibitors, the GLP-1 receptor agonist-SGLT-2 inhibitor combination was associated with a 29% lower risk of major adverse cardiovascular events (7.6 v 10.7 events per 1000 person years; hazard ratio 0.71, 0.52 to 0.98), whereas serious renal events generated a wide confidence interval (1.4 v 2.0 events per 1000 person years; hazard ratio 0.67, 0.32 to 1.41). Secondary outcomes generated similar results but with wider confidence intervals.

CONCLUSIONS  In this cohort study, the GLP-1 receptor agonist-SGLT-2 inhibitor combination was associated with a lower risk of major adverse cardiovascular events and serious renal events compared with either drug class alone.

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