Centre for Clinical Epidemiology, Lady Davis Institute, Jewish General Hospital, 3755 Cote Ste-Catherine Road, Suite H485, Montreal, Quebec, Canada
Departments of Medicine and of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec, Canada.
BMJ. 2020 Sep 23;370:m3342. doi: 10.1136/bmj.m3342.
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 16.5; hazard ratio 0.76, 95% confidence interval 0.69 to 0.84), myocardial infarction (5.1 6.4; 0.82, 0.70 to 0.96), cardiovascular death (3.9 7.7; 0.60, 0.54 to 0.67), heart failure (3.1 7.7; 0.43, 0.37 to 0.51), and all cause mortality (8.7 17.3; 0.60, 0.54 to 0.67). SGLT2 inhibitors had more modest benefits for ischaemic stroke (2.6 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.
在真实临床实践环境下，比较钠-葡萄糖共转运蛋白 2（SGLT2）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。
使用基于新用户的多数据库回顾性队列研究设计，随后进行荟萃分析。
加拿大观察性药物效应研究网络（CNODES），使用来自加拿大 7 个省份和英国的行政医疗保健数据库，2013-18 年。
209867 名新使用 SGLT2 抑制剂的患者与 209867 名新使用 DPP-4 抑制剂的患者按照时间条件倾向评分匹配，并随访平均 0.9 年。
主要心血管不良事件（MACE，包括心肌梗死、缺血性卒中和心血管死亡的复合终点）。次要结局指标为 MACE 的各个组成部分、心力衰竭和全因死亡率。采用 Cox 比例风险模型估计特定地点的调整后风险比和 95%置信区间，比较 SGLT2 抑制剂与 DPP-4 抑制剂的治疗效果。使用随机效应荟萃分析汇总特定地点的结果。
与 DPP-4 抑制剂相比，SGLT2 抑制剂与较低的 MACE 风险相关（每 1000 人年发生率：11.4 16.5；风险比 0.76，95%置信区间 0.69 至 0.84）、心肌梗死（5.1 6.4；0.82，0.70 至 0.96）、心血管死亡（3.9 7.7；0.60，0.54 至 0.67）、心力衰竭（3.1 7.7；0.43，0.37 至 0.51）和全因死亡率（8.7 17.3；0.60，0.54 至 0.67）。SGLT2 抑制剂对缺血性卒中有更适度的益处（2.6 3.5；0.85，0.72 至 1.01）。卡格列净（0.79，0.66 至 0.94）、达格列净（0.73，0.63 至 0.85）和恩格列净（0.77，0.68 至 0.87）也观察到了类似的 MACE 获益。
在这项在真实临床实践环境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 SGLT2 抑制剂与心血管事件风险降低相关。
ClinicalTrials.gov NCT03939624。
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