The sodium‐glucose cotransporter‐2 inhibitor canagliflozin does not increase risk of non‐genital skin and soft tissue infections in people with type 2 diabetes mellitus: A pooled post hoc analysis from the CANVAS Program and CREDENCE randomized double‐blind trials

Kang, A; Smyth, B; Neuen, BL; Heerspink, HJL; Di Tanna, GL; Zhang, H; Arnott, C; Hockham, C; Agarwal, R; Bakris, G; Charytan, DM; de Zeeuw, D; Greene, T; Levin, A; Pollock, C; Wheeler, DC; Mahaffey, KW; Perkovic, V; Jardine, MJ

doi:10.1111/dom.15091

The sodium‐glucose cotransporter‐2 inhibitor canagliflozin does not increase risk of non‐genital skin and soft tissue infections in people with type 2 diabetes mellitus: A pooled post hoc analysis from the CANVAS Program and CREDENCE randomized double‐blind trials

Diabetes Obes MetabPublished 10 May 2023Post hoc pooled individual participant analysis of the CANVAS Program and CREDENCE randomised trials

Primary result · Non-genital SSTIResultHazard ratio 0.97 95% CI 0.85–1.11

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Authors' conclusion

Canagliflozin did not affect risk of non-genital SSTIs or non-genital fungal SSTIs compared with placebo. These findings suggest that any SGLT2 inhibitor-mediated change in skin microenvironment is unlikely to have meaningful clinical consequences.

Study context

Population: People with T2D at high cardiovascular risk and/or with CKD, CANVAS Program and CREDENCE trials
Participants: 14,531 people

Comparison: Canagliflozin vs placebo
Primary endpoint: Non-genital skin and soft tissue infections (SSTIs)
Follow-up: Median 26 months

Methodological detailsdouble-blind, blinded adjudication of adverse events by predetermined criteria

Double-blind
Blinded adjudication of adverse events by predetermined criteria

Primary result

Non-genital SSTI

Hazard ratio

0.97

95% CI 0.85–1.11

P = 0.70

By group

Canagliflozin

24.0 events/1000 person-years

Placebo

23.9 events/1000 person-years

Canagliflozinvs Placebo

HR 0.97 (95% CI 0.85–1.11); P = 0.70

As reported in the abstract

Participants with non-genital skin and soft tissue infections (SSTIs) overall: 903 (6%)

Further findings

Outcome	← Lower risk with canagliflozin ←→ Higher risk with canagliflozin →	HR (95% CI)	P value
Recurrent non-genital SSTI events	0.512	1.06 (0.94–1.19)	P = 0.32
Non-genital fungal infection	0.512	1.18 (0.88–1.60)	P = 0.27
	0.512Hazard ratio (log scale)

Non-genital SSTI by prespecified subgroups

Consistent results across subgroups: all P interaction > 0.05

Baseline factors independently associated with non-genital SSTIs

Younger age, male sex, higher BMI, higher HbA1c, lower estimated glomerular filtration rate (eGFR), established peripheral vascular disease, history of neuropathy

Multivariable Cox regression

Original publication

The sodium‐glucose cotransporter‐2 inhibitor canagliflozin does not increase risk of non‐genital skin and soft tissue infections in people with type 2 diabetes mellitus: A pooled post hoc analysis from the CANVAS Program and CREDENCE randomized double‐blind trials. Diabetes Obes Metab. Published 10 May 2023. doi:10.1111/dom.15091

Read the original article ↗

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