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Abstract: PO1004

Canagliflozin and Risk of Genital Infections and Urinary Tract Infections in People with Diabetes Mellitus and Kidney Disease in the CREDENCE Trial

Session Information

Category: Diabetic Kidney Disease

  • 602 Diabetic Kidney Disease: Clinical

Authors

  • Kang, Amy, The George Institute for Global Health UNSW Sydney, Sydney, New South Wales, Australia
  • Neuen, Brendon Lange, The George Institute for Global Health UNSW Sydney, Sydney, New South Wales, Australia
  • L Heerspink, Hiddo Jan, Rijksuniversiteit Groningen, Groningen, Groningen, Netherlands
  • Di Tanna, Gian Luca, The George Institute for Global Health UNSW Sydney, Sydney, New South Wales, Australia
  • Neal, Bruce, The George Institute for Global Health UNSW Sydney, Sydney, New South Wales, Australia
  • Zhang, Hong, Peking University First Hospital, Beijing, Beijing, China
  • Hockham, Carinna, The George Institute for Global Health UNSW Sydney, Sydney, New South Wales, Australia
  • Agarwal, Rajiv, Indiana University School of Medicine, Indianapolis, Indiana, United States
  • Bakris, George L., University of Chicago, Chicago, Illinois, United States
  • Charytan, David M., NYU Langone Health, New York, New York, United States
  • de Zeeuw, Dick, Rijksuniversiteit Groningen, Groningen, Groningen, Netherlands
  • Greene, Tom, University of Utah Health, Salt Lake City, Utah, United States
  • Levin, Adeera, The University of British Columbia Faculty of Medicine, Vancouver, British Columbia, Canada
  • Pollock, Carol A., University of Sydney - Camperdown and Darlington Campus Burkitt-Ford Library, Sydney, New South Wales, Australia
  • Wheeler, David C., University College London, London, London, United Kingdom
  • Zinman, Bernard, Lunenfeld-Tanenbaum Research Institute, Toronto, Ontario, Canada
  • Mahaffey, Kenneth W., Stanford University, Stanford, California, United States
  • Perkovic, Vlado, The George Institute for Global Health UNSW Sydney, Sydney, New South Wales, Australia
  • Jardine, Meg J., The George Institute for Global Health UNSW Sydney, Sydney, New South Wales, Australia
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.

Conclusion

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 –