Trial reportNephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association2026
Urinary dipstick findings and UTI risk with SGLT2 inhibitors: a post-hoc analysis of the CANVAS and CREDENCE trials.
Trial report in Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
backgroundDespite established cardiorenal benefits, concerns about urinary tract infection (UTI) risk may limit sodium-glucose cotransporter 2 inhibitor (SGLT2i) use, especially in high-risk patients. We hypothesized that urine leukocyte esterase (LE) and nitrite-findings compatible with pyuria or bacteriuria-predict subsequent UTI risk and modify the association between canagliflozin and UTIs.
methodsWe conducted a post-hoc analysis of individual-participant data from two randomized, double-blind, placebo-controlled trials of canagliflozin in type 2 diabetes. The primary outcome was time to first UTI; the secondary outcome was total UTI events, analyzed with Cox and Andersen-Gill models.
resultsAmong 8614 participants, abnormal LE and nitrite were observed in 10.7% and 3.5%, respectively. After adjustment, the risk of first UTI increased with greater LE positivity [hazard ratio (HR) 1.72, 1.92, 2.81 for 1+, 2+, 3+ vs normal]. Abnormal nitrite was also associated with higher risk [HR 2.28 (1+), 1.66 (2+)]. Similar findings were observed for total UTI events. Overall, canagliflozin did not increase risk of first [HR 1.07; 95% confidence interval (CI) 0.93-1.22] or total UTI events (HR 1.01; 95% CI 0.86-1.17). LE and nitrite results did not significantly modify the effect of canagliflozin on the primary outcome. For LE, the HR for first UTI was 1.17 (95% CI 1.00-1.38) in the normal group and 0.94 (0.73-1.21) in the abnormal group (Pinteraction = .10). For nitrite, the HRs were 1.08 (0.94-1.24) and 0.92 (0.59-1.43), respectively (Pinteraction = .45). For the secondary outcome, canagliflozin also did not increase the risk of total UTI events in either the abnormal LE or nitrite group [HR 0.76 (0.58-0.99) and 1.18 (0.79-1.76), respectively].
conclusionsAlthough abnormal LE and nitrite were associated with increased UTI risk, canagliflozin did not further increase this risk in these subgroups. These findings do not support routine withholding of SGLT2i in patients with dipstick findings suggestive of pyuria or bacteriuria.
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