Canagliflozin and Risk of Genital Infections and Urinary Tract Infections in People with Diabetes Mellitus and Kidney Disease in the CREDENCE Trial
Bibliographic record
Abstract
Background: Genital mycotic infections (GMI) and urinary tract infections (UTI) are common in patients with diabetes. We assessed the effects of canagliflozin on the risk of these infections in the CREDENCE trial population. Methods: The CREDENCE trial randomised people with type 2 diabetes and albuminuric stage 2 and 3 chronic kidney disease to canagliflozin 100mg daily or placebo. We analysed the risk of GMI and UTI with canagliflozin compared to placebo overall and in subgroups. The primary analysis was conducted in the on-treatment population. When canagliflozin increased risk, we determined patient risk factors for GMIs using multivariable Cox regression models. Results: Overall 31/2905 (1.1%) men and 32/1492 (2.1%) women experienced 91 GMIs and 166/2905 (5.7%) men and 300/1492 (20.1%) women experienced 669 UTIs. 58/669 (8.7%) UTIs but no GMIs were reported as serious. Most participants continued treatment following their first infection with similar recurrence rates in the canagliflozin and placebo groups. Canagliflozin increased the risk of GMI (HR 3.83 [95% CI 2.08-7.06] p<0.0001). The hazard ratio (HR) for canagliflozin compared to placebo was consistent across most subgroups, though canagliflozin led to a greater increase in risk in those with a BMI>30 kg/m2 compared to those with a BMI<30 kg/m2 (HR 5.91 vs 1.36, p interaction=0.03) and in men compared to women (HR 9.30 vs HR 2.10, p interaction=0.04). In those who were randomised to canagliflozin, independent risk factors for GMI were higher BMI (HR 1.53 [95% CI 1.29-1.83] per 5 units p<0.0001) and longer diabetes duration (HR 1.18 [95% CI 1.01-1.40] per 5 years p=0.04). Canagliflozin did not affect the risk of UTI (HR 1.08 [95% CI 0.90-1.29] p=0.42) overall or in any subgroup. Conclusions: Canagliflozin increased risk of GMI but not UTI. The proportional increase in GMI with canagliflozin was greater in men and people with higher BMI. Funding: Commercial Support - Janssen sponsored the CREDENCE trial but did not sponsor this post-hoc analysis
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.004 | 0.007 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.002 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.005 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".