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Table 3 Key safety outcomes in SGLT2 inhibitor CVOTs

From: SGLT2 inhibitors in T2D and associated comorbidities — differentiating within the class

  EMPA-REG OUTCOME [45, 46]* CANVAS [17, 46] CANVAS-R [17, 46] DECLARE-TIMI 58† [18, 46]
  Placebo (N = 2333) Empa 10 (N = 2345) Empa 25 (N = 2342) Placebo (N = 1441) Cana 100 (N = 1445) Cana 300 (N = 1441) Placebo (N = 2903) Cana 100 (N = 2904) Placebo (N = 8569) Dapagliflozin (N = 8574)
Patients with lower limb amputation
 n (%) 43 (1.8) 42 (1.8) 46 (2.0) 22 (1.5) 50 (3.5) 45 (3.1) 25 (0.9) 45 (1.5) 113 (1.3) 123 (1.4)
 Events per 1000 patient-years 6.5 6.2 6.8 2.8 6.2 5.5 4.2 7.5 3.3 3.6
 Hazard ratio (95% CI) 0.96 (0.63–1.47) 1.04 (0.69–1.58) 2.24 (1.36–3.69) 2.01 (1.20–3.34) 1.80 (1.10–2.93) 1.09 (0.84–1.40)
Diabetic ketoacidosis
  Placebo (N = 2333) Empagliflozin (pooled) (N = 4687) Placebo (pooled‡) (N = 4347) Canagliflozin (pooled‡) (N = 5795) Placebo (N = 8569) Dapagliflozin (N = 8574)
 n (%) 1 (< 0.1%) 4 (0.1%) 6 12 12 27
 Events per 1000 patient-years < 0.1 0.1 0.3 0.6 0.4 0.9
 Hazard ratio (95% CI) 1.99 (0.22–17.80) 2.33 (1.10–7.17) 2.18 (1.10–4.30)
  1. These trials cannot be directly compared, owing to differences in study design, populations and methodology. *Post hoc analysis for lower limb amputation, which was not a prespecified outcome in EMPA-REG OUTCOME. †All amputation; data for lower limb amputation not provided. ‡Diabetic ketoacidosis events pooled across CANVAS and CANVAS-R, and 100 mg and 300 mg doses of canagliflozin. Pooled cohort size indicates the intention to treat population. Cana 100/300, canagliflozin 100/300 mg; Empa 10/25, empagliflozin 10/25 mg