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Abstract: PO1005

Canagliflozin and Risk of Skin and Soft Tissue 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, Newtown, New South Wales, Australia
  • Smyth, Brendan, The George Institute for Global Health, UNSW Sydney, Newtown, New South Wales, Australia
  • Neuen, Brendon Lange, The George Institute for Global Health, UNSW Sydney, Newtown, 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, Newtown, New South Wales, Australia
  • Neal, Bruce, The George Institute for Global Health, UNSW Sydney, Newtown, New South Wales, Australia
  • Zhang, Hong, Peking University First Hospital, Beijing, Beijing, China
  • Hockham, Carinna, The George Institute for Global Health, UNSW Sydney, Newtown, 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, Newtown, New South Wales, Australia
  • Jardine, Meg J., The George Institute for Global Health, UNSW Sydney, Newtown, New South Wales, Australia
Background

The skin’s hypertonic microenvironment has a protective antimicrobial function that may be disrupted by sodium glucose cotransporter 2 inhibitors (SGLT2i). We aimed to describe skin and soft tissue infections (SSTI) in the CREDENCE trial and determine whether canagliflozin affects the risk of SSTIs.

Methods

We performed a post-hoc analysis of the CREDENCE trial that randomised people with type 2 diabetes and albuminuric stage 2 and 3 chronic kidney disease to either canagliflozin 100mg daily or placebo. Adverse events were assessed by two blinded authors following predetermined criteria for SSTI with discrepancies resolved by consensus. We analysed the risks of SSTIs in the on-treatment population as the more conservative approach, with sensitivity analyses conducted in the intention-to-treat population, for serious events only and for participant subgroups. Univariable time-to first-event regression models were assessed.

Results

Overall 373/4397 (8.5%) participants experienced 478 events comprising 252 bacterial skin infections (including 2 episodes of necrotising fasciitis), 94 fungal skin infections, 109 other skin infections and 23 soft tissue infections. Of these, 136/478 (28%) were serious.

Canagliflozin did not increase the risk of SSTI (HR 0.85 [95% Confidence Interval (CI) 0.69-1.04] p=0.11), with similar results in the intention-to-treat population (HR 0.88 [95% CI 0.73-1.07] p=0.20), in analyses confined to serious SSTI (HR 0.83 [95% CI 0.58-1.21] p=0.33) and participant subgroups (all p interaction≥0.10). Both cases of necrotising fasciitis were in patients assigned to canagliflozin and the participants recovered after drug was withdrawn.

Conclusion

Canagliflozin did not increase the risk of skin and soft tissue infections overall or in any subgroup, in CREDENCE trial participants with type 2 diabetes mellitus and albuminuric chronic kidney disease.

Funding

  • Commercial Support