Type 2 diabetes, sodium-glucose cotransporter-2 inhibitors and cardiovascular outcomes: real world evidence versus a randomised clinical trial

作者：Puriya Daniel Würtz Yazdanfard, Kathrine Kold Sørensen, Bochra Zareini, Ulrik Pedersen‐Bjergaard, Johan Sebastian Ohlendorff, Anders Munch, Mikkel Porsborg Andersen, Rasmus Bo Hasselbalch, Henrik Imberg, Viktor Tasseleus, Marcus Lind, Jonathan Valabhji, Pratik Choudhary, Kamlesh Khunti, Stefanie Schmid, Stefanie Lanzinger, Julia K. Mader, Thomas Alexander Gerds, Christian Torp‐Pedersen · 发表于：Cardiovascular Diabetology · 年份：2025 · DOI：10.1186/s12933-025-02924-0 · 被引用次数：3 · 研究领域：Diabetes Treatment and Management、Heart Failure Treatment and Management、Pancreatic function and diabetes

BACKGROUND: Sodium-glucose cotransporter-2 inhibitors (SGLT2i) have demonstrated cardiovascular benefits in randomised controlled trials (RCT). However, the controlled nature of RCTs and the selected trial populations limit their generalizability to real-world practice. Substantial methodological advances now enable robust estimation of absolute risks, risk differences, and continuous on-treatment effects, providing more clinically interpretable measures of SGLT2i effectiveness than previously possible with traditional models reliant on hazard ratios. METHODS: We conducted a target trial emulation using nationwide Danish registries to evaluate the real-world effectiveness of SGLT2i versus dipeptidyl peptidase-4 inhibitors (DPP4i) in individuals with type 2 diabetes (T2D) and cardiovascular disease (CVD). Outcomes included major adverse cardiovascular events (MACE), heart failure hospitalizations, and all-cause mortality. Absolute risks and risk differences for three years of continuous treatment were estimated using longitudinal targeted minimum loss-based estimation, adjusting for baseline and time-varying confounders. RESULTS: Among 116,823 patients who redeemed SGLT2i or DPP4i for the first time, 13,524 met inclusion and exclusion criteria (SGLT2i: 6,025; DPP4i: 7,499). At three years, the risk of MACE was 11.5% for SGLT2i users versus 14.2% for DPP4i users (risk-difference: 2.8 percentage-points, 95% CI: 1.1-4.4%). Heart failure hospitalizations were lower by 5.1 percenta...