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Background <p>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.</p> Methods <p>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.</p> Results <p>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 <i>percentage-points</i>, 95% CI: 1.1–4.4%). Heart failure hospitalizations were lower by 5.1 <i>percentage-points</i> (95% CI: 4.3–6.0%), and all-cause mortality by 3.1 <i>percentage-points</i> (95% CI: 1.5–4.7%), all favoring SGLT2i. Notably, we also observed a risk reduction in stroke by 2.4 <i>percentage-points</i> (95% CI: 1.7–3.1%).</p> Conclusions <p>This study demonstrates the real-world effectiveness of continuous SGLT2i treatment in reducing cardiovascular events in patients with T2D and CVD. The absolute benefit of SGLT2i was larger in a real world population than in the intention to treat estimate in clinical trials.</p>

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

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年9月30日

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  • 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 Mader,
  • Thomas Alexander Gerds,
  • Christian Torp-Pedersen

摘要

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 percentage-points (95% CI: 4.3–6.0%), and all-cause mortality by 3.1 percentage-points (95% CI: 1.5–4.7%), all favoring SGLT2i. Notably, we also observed a risk reduction in stroke by 2.4 percentage-points (95% CI: 1.7–3.1%).

Conclusions

This study demonstrates the real-world effectiveness of continuous SGLT2i treatment in reducing cardiovascular events in patients with T2D and CVD. The absolute benefit of SGLT2i was larger in a real world population than in the intention to treat estimate in clinical trials.