Sodium glucose cotransporter 2 inhibitors and risk of major adverse cardiovascular events: multi-database retrospective cohort study.
Sodium glucose cotransporter 2 inhibitors and risk of major adverse cardiovascular events: multi-database retrospective cohort study.
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DOI：
10.1136/bmj.m3342
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发表时间：
2020-09-23
期刊：
影响因子：
--
通讯作者：
Canadian Network for Observational Drug Effect Studies (CNODES) Investigators
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文献类型：
--
作者：
Filion KB;Lix LM;Yu OH;Dell'Aniello S;Douros A;Shah BR;St-Jean A;Fisher A;Tremblay E;Bugden SC;Alessi-Severini S;Ronksley PE;Hu N;Dormuth CR;Ernst P;Suissa S;Canadian Network for Observational Drug Effect Studies (CNODES) Investigators
在真实的临床实践背景下，比较钠葡萄糖协同转运蛋白2（SGLT 2）抑制剂和二肽基肽酶-4（DPP-4）抑制剂在2型糖尿病患者中的心血管事件风险。多数据库回顾性队列研究，采用流行的新用户设计，随后进行荟萃分析。加拿大观察性药物效应研究网络（hocDES），来自加拿大七个省和英国的行政医疗保健数据库，2013-18。209 867例SGLT 2抑制剂新使用者与209 867例DPP-4抑制剂使用者按时使用条件倾向评分匹配，平均随访0.9年。主要结局为主要不良心血管事件（MACE，心肌梗死、缺血性卒中或心血管死亡的复合终点）。次要结局是MACE、心力衰竭和全因死亡率的各个组成部分。使用考克斯比例风险模型估计研究中心特定的校正风险比和95%置信区间，比较SGLT 2抑制剂与DPP-4抑制剂在实际治疗方法中的使用。使用随机效应荟萃分析汇总研究中心特定结果。与DPP-4抑制剂相比，SGLT 2抑制剂与MACE风险降低相关（每1000人年的发病率：11.4 vs 16.5;风险比0.76，95%置信区间0.69 - 0.84），心肌梗死（5.1 v 6.4; 0.82，0.70 - 0.96），心血管死亡（3.9 v 7.7; 0.60，0.54 - 0.67）、心力衰竭（3.1 v 7.7; 0.43，0.37 - 0.51）和全因死亡率（8.7 v 17.3; 0.60，0.54 - 0.67）。SGLT 2抑制剂对缺血性卒中的获益更适中（2.6 vs 3.5; 0.85，0.72 - 1.01）。卡格列净（0.79，0.66 - 0.94）、达格列净（0.73，0.63 - 0.85）和恩格列净（0.77，0.68 - 0.87）的MACE获益相似。在这项在真实的世界临床实践背景下进行的大型观察性研究中，与使用DPP-4抑制剂相比，短期使用SGLT 2抑制剂与心血管事件风险降低相关。ClinicalTrials.gov NCT03939624。
To compare the risk of cardiovascular events between sodium glucose cotransporter 2 (SGLT2) inhibitors and dipeptidyl peptidase-4 (DPP-4) inhibitors among people with type 2 diabetes in a real world context of clinical practice. Multi-database retrospective cohort study using a prevalent new user design with subsequent meta-analysis. Canadian Network for Observational Drug Effect Studies (CNODES), with administrative healthcare databases from seven Canadian provinces and the United Kingdom, 2013-18. 209 867 new users of a SGLT2 inhibitor matched to 209 867 users of a DPP-4 inhibitor on time conditional propensity score and followed for a mean of 0.9 years. The primary outcome was major adverse cardiovascular events (MACE, a composite of myocardial infarction, ischaemic stroke, or cardiovascular death). Secondary outcomes were the individual components of MACE, heart failure, and all cause mortality. Cox proportional hazards models were used to estimate site specific adjusted hazards ratios and 95% confidence intervals, comparing use of SGLT2 inhibitors with use of DPP-4 inhibitors in an as treated approach. Site specific results were pooled using random effects meta-analysis. Compared with DPP-4 inhibitors, SGLT2 inhibitors were associated with decreased risks of MACE (incidence rate per 1000 person years: 11.4 v 16.5; hazard ratio 0.76, 95% confidence interval 0.69 to 0.84), myocardial infarction (5.1 v 6.4; 0.82, 0.70 to 0.96), cardiovascular death (3.9 v 7.7; 0.60, 0.54 to 0.67), heart failure (3.1 v 7.7; 0.43, 0.37 to 0.51), and all cause mortality (8.7 v 17.3; 0.60, 0.54 to 0.67). SGLT2 inhibitors had more modest benefits for ischaemic stroke (2.6 v 3.5; 0.85, 0.72 to 1.01). Similar benefits for MACE were observed with canagliflozin (0.79, 0.66 to 0.94), dapagliflozin (0.73, 0.63 to 0.85), and empagliflozin (0.77, 0.68 to 0.87). In this large observational study conducted in a real world clinical practice context, the short term use of SGLT2 inhibitors was associated with a decreased risk of cardiovascular events compared with the use of DPP-4 inhibitors. ClinicalTrials.gov NCT03939624.
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