Diabetes drug did not add urinary infection risk with abnormal tests
In 8,614 people with type 2 diabetes, the relative risk measure for first urinary infection was 1.07 for canagliflozin versus placebo.
Randomized trial, double-blind, placebo-controlled
Limit: Urinary infections were investigator-reported without standardized diagnostic criteria, risking inconsistent detection or misclassification
Edited by Boris Djordjevic · AgingResearch.News
The 8,614 participants had type 2 diabetes and a mean age of 62; 34.8% were female. This post-hoc analysis pooled two randomized, placebo-controlled trials. Canagliflozin doses were 100 or 300 milligrams in CANVAS and 100 milligrams in CREDENCE. Median follow-up for urinary infections was 2.8 years.
Abnormal urine dipstick findings suggesting white blood cells or bacteria were linked to higher urinary infection risk. Canagliflozin did not further increase first-infection risk in these groups. The overall estimate’s uncertainty range included no difference. Reported urinary-infection withdrawal figures were 2.1% (13/619) with placebo and 2.9% (27/942) with canagliflozin. Canagliflozin was also associated with a shorter time to a first genital fungal infection (time ratio 0.04; 1 means no difference).
Why it matters
For people managing type 2 diabetes as they age, the analysis informs decisions about balancing a drug’s heart and kidney benefits against infection concerns.
Caveats
This was a post-hoc, on-treatment analysis, and investigators reported infections as adverse events. Participants had cardiovascular disease or risk factors, or kidney disease; the results do not cover everyone with diabetes.
From the paper
- Participants
Baseline dipstick data were available for 98.7% (8614/8724) of the on-treatment population.
- Who took part
Both were randomized, double-blind, placebo-controlled, multicenter trials evaluating canagliflozin in patients with T2DM.
- Ages
Of these, 34.8% (2915/8614) were female, the mean age was 62 years and the median follow-up was 2.8 years (IQR 1.9–4.1) for the on-treatment UTI analysis and 3.5 years (IQR 2.5–6.1) for the MGI analysis.
- Result
When LE and NIT were included simultaneously in Model 3, both were independently associated with first UTI events (LE: HR 2.09; 95% CI 1.78–2.47; NIT: HR 1.41; 95% CI 1.11–1.80).
- Urinary tract infection
Canagliflozin did not significantly affect the risk of first UTI events in the overall population (HR 1.07; 95% CI 0.93–1.22; Table, Fig. ).
Quoted word for word from the full text on PubMed Central.
The paper
Ehime University; The University of Osaka
Nephrology, Dialysis, Transplantation, Mar 16, 2026, Open access
