Post‐authorisation safety study to assess the risk of urinary tract cancer in people with type 2 diabetes initiating empagliflozin: A multi‐country European study
Main finding · UTCResult — go to the resultAdjusted hazard ratio 0.88 95% CI 0.66–1.17Authors' conclusion
No increased risk of UTC, bladder, and renal cancer was observed when empagliflozin initiators were compared with DPP-4i initiators in this non-interventional cohort study.
Study context
- Population
- Propensity score-matched adults with T2D initiating empagliflozin or a DPP-4i between 2014 and 2020 (2021 for the United Kingdom (UK)) in the UK, Sweden and Finland; empagliflozin initiators mean age 57.0–63.2 years, 59.6%-67.8% femalematched
- Participants
- 151,055 adults
- Exposure
- Empagliflozin initiators vs DPP-4i initiators
- Outcome
- Urinary tract cancers (UTCs), including bladder and renal cancers
Methodological detailsnon-interventional, secondary data, active comparator, new user design, propensity score-matched, as-treated approach, random-effects meta-analysis of country-level hazard ratios (HRs), 180-day latency period
- Non-interventional
- Secondary data
- Active comparator, new user design
- Propensity score-matched
- As-treated approach
- Random-effects meta-analysis of country-level HRs
- 180-day latency period
Main finding
UTC
Adjusted hazard ratio
0.88
95% CI 0.66–1.17
Empagliflozinvs DPP-4i
adjusted HR 0.88 (95% CI 0.66–1.17)
As reported in the abstract
Observational data: associations, not effects.
Further findings
| Outcome | Adjusted HR (95% CI) | |
|---|---|---|
| Bladder cancer | 0.91 (0.63–1.33) | |
| Renal cancer | 0.89 (0.57–1.38) | |
| 0.512Adjusted hazard ratio (log scale) |
Sensitivity analyses
- Various sensitivity analyses validated the robustness of the main findings
Original publication
Post‐authorisation safety study to assess the risk of urinary tract cancer in people with type 2 diabetes initiating empagliflozin: A multi‐country European study. Diabetes Obes Metab. Published 13 June 2025. doi:10.
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