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Table 2 Key efficacy outcomes in SGLT2 inhibitor CVOTs

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

 

EMPA-REG OUTCOME [16, 33]

CANVAS Program [17, 34]

DECLARE-TIMI 58 [18]

Placebo

(N = 2333)

Empagliflozin

(N = 4687)

Placebo

(N = 4347)

Canagliflozin

(N = 5795)

Placebo

(N = 8578)

Dapagliflozin

(N = 8582)

3P-MACE (CV death, MI or stroke)

 Rate per 1000 pt-yrs

43.9

37.4

31.5

26.9

24.2

22.6

 HR (95% CI; p-value)

0.86 (0.74–0.99; p = 0.04)

0.86 (0.75–0.97; p = 0.02)

0.93 (0.84–1.03; p = 0.17)

 RRR (ARR)

14% (6.5 events/1000 pt-ys)

14% (4.6 events/1000 pt-yrs)

N/A

CV death

 Rate per 1000 pt-yrs

20.2

12.4

12.8

11.6

7.1

7.0

 HR (95% CI; p-value)

0.62 (0.49–0.77; p < 0.001)

0.87 (0.72–1.06)†

0.98 (0.82–1.17)†

 RRR (ARR)

38% (7.8 events/1000 pt-yrs)

N/A

N/A

Death by any cause

 Rate per 1000 pt-yrs

28.6

19.4

19.5

17.3

16.4

15.1

 HR (95% CI; p-value)

0.68 (0.57–0.82; p < 0.001)

0.87 (0.74–1.01; p = 0.24)

0.93 (0.82–1.04)†

 RRR (ARR)

32% (9.2 events/1000 pt-yrs)

N/A

N/A

HHF

 Rate per 1000 pt-yrs

14.5

9.4

8.7

5.5

8.5

6.2

 HR (95% CI; p-value)

0.65 (0.50–0.85; p = 0.002)

0.67 (0.52–0.87)†

0.73 (0.61–0.88)†

 RRR (ARR)

35% (5.1 events/1000 pt-yrs)

33% (3.2 events/1000 pt-yrs)

27% (2.3 events/1000 pt-yrs)

Renal composite (renal function decline*, ESRD or renal death)

 Rate per 1000 pt-yrs

11.5

6.3

9.0

5.5

7.0

3.7

 HR (95% CI; p-value)

0.54 (0.40–0.75; p < 0.001)†

0.60 (0.47–0.77)†

0.53 (0.43–0.66)†

 RRR (ARR)

46% (5.2 events/1000 pt-yrs)

40% (3.5 events/1000 pt-yrs)

47% (3.3 events/1000 pt-yrs)

Alternative renal composite (progression to macroalbuminuria, dSCr, ESRD or renal death)

 Rate per 1000 pt-yrs

76.0

47.8

27.4

15.1

Not reported

 HR (95% CI; p-value)

0.61 (0.53–0.70; p < 0.001)

0.58 (0.50–0.67)†

 RRR (ARR)

39% (28.2 events/1000 pt-yrs)

42% (12.3 events/1000 pt-yrs)

  1. Please note that direct comparison of trials may not be accurate owing to differences in study design, populations and methodology. RRR and ARR are only shown where a significant reduction was reported, or a nominally significant reduction in the case of an exploratory analysis. *Defined as: dSCr accompanied by eGFR of < 45 ml/min/1.73 m2 in EMPA-REG OUTCOME; ≤40% decrease in eGFR in the CANVAS Program; and ≤ 40% decrease in eGFR to < 60 ml/min/1.73 m2 in DECLARE-TIMI 58. †Exploratory analysis, p-value is nominal or not available. 3P-MACE, 3-point major adverse CV event; ARR, absolute risk reduction; CI, confidence interval; CV, cardiovascular; dSCr, doubling of serum creatinine; HHF, hospitalisation for heart failure; HR, hazard ratio; MI, myocardial infarction; pt-yrs, patient-years; RRR, relative risk reduction
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BMC Endocrine Disorders

ISSN: 1472-6823

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