What question did this study set out to answer?

To evaluate the ongoing risk of urinary tract infections (UTIs) among users of sodium-glucose cotransporter 2 inhibitors (SGLT2i) without establishing causality.

April 17, 2026Open Access

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Active surveillance of drug safety in healthcare data: Sequential monitoring of bacterial and serious urinary tract infection risk in sodium‐glucose cotransporter 2 inhibitor users

HLHaoxin LeUniversity of Copenhagen DPDilsad Simay PekerUniversity of Copenhagen LWLukas Frederic WestphalUniversity of Copenhagen

Key Points

To evaluate the ongoing risk of urinary tract infections (UTIs) among users of sodium-glucose cotransporter 2 inhibitors (SGLT2i) without establishing causality.
Conducted continuous surveillance of healthcare data
Analyzed incidence rates of urinary tract infections
Monitored health risks from 2016 onwards
Incidence rate of serious urinary tract infections was low
Hazard ratios remained stable, indicating no increased risk over time

Abstract

This is the first study demonstrating the feasibility of continuous surveillance for evaluating real-world UTI risk among SGLT2i users without aiming to establish causality. The IR of serious events was low, and stable HRs indicate no increased risk from 2016.

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Active surveillance of drug safety in healthcare data: Sequential monitoring of bacterial and serious urinary tract infection risk in sodium‐glucose cotransporter 2 inhibitor users

Key Points

Abstract

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