Enhancing evidence-based care using trial emulation in electronic health records: real-world effects of empagliflozin in people with type 2 diabetes
Primary result · All-cause mortalityResult — go to the resultAdjusted hazard ratio 0.76 95% CI 0.69–0.83Authors' conclusion
Patients prescribed empagliflozin in real-world settings differ substantially from those enrolled in the EMPA-REG RCT. Using electronic health records, we demonstrate that the mortality benefit observed in EMPA-REG extends to a broader, more diverse real-world population, including those excluded from the original RCT. These findings provide a novel source of real-world evidence supporting the wider use of empagliflozin in routine clinical practice.
Study context
- Population
- Adults with T2D initiating empagliflozin or DPP-4i between January 1, 2014 and December 31, 2022, UK primary care; both RCT-eligible and RCT-ineligible
- Participants
- 13,239 vs 49,264
- Comparison
- Empagliflozin vs DPP-4i
- Empagliflozinn = 13,239
- Active controln = 49,264reference
- Primary endpoint
- All-cause mortality
Methodological detailsbased on the EMPA-REG RCT, active comparator, UK primary care data, stratified analyses by RCT eligibility
- Based on the EMPA-REG RCT
- Active comparator
- UK primary care data
- Stratified analyses by RCT eligibility
Primary result
As reported in the abstract
during follow-up
Adjusted hazard ratio
0.76
95% CI 0.69–0.83
Events by treatment group
Empagliflozinvs Active control
aHR 0.76 (95% CI 0.69–0.83)
Further findings
- Empagliflozin users not meeting EMPA-REG RCT eligibility
- 83.2% · 11,011 of 13,239
All-cause mortality by RCT eligibility status
- No evidence of differential treatment effect by RCT eligibility status
- P for interaction = 0.27
Original publication
Enhancing evidence-based care using trial emulation in electronic health records: real-world effects of empagliflozin in people with type 2 diabetes. BMJ Open Diabetes Res Care. Published 9 February 2026. doi:10.
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