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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
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BMC Endocrine Disorders

ISSN: 1472-6823

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