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Table 4 Comparison of outcome results from terminated CVOTs in comparison to placebo

From: Current perspectives on cardiovascular outcome trials in diabetes

Cardiovascular endpoints

SAVOR-TIMI53 [43, 45]

EXAMINE [47, 48]

TECOS [50]

ELIXA [44]

EMPA-REG OUTCOME [48, 49]

LEADER [51]

SUSTAIN-6 [52]

Class

Hazard ratio (95 % CI)

p value

Class

Hazard ratio (95 % CI)

p value

Class

Hazard ratio (95 % CI)

p value

Class

Hazard ratio (95 % CI)

p value

Class

Hazard ratio (95 % CI)

p value

Class

Hazard ratio (95 % CI)

p value

Class

Hazard ratio (95 % CI)

p value

Primary composite MACE

CV death, MI, or stroke

1.00 (0.89-1.12)

0.99

CV death, MI, or stroke

0.96 (≤1.16)

0.315

CV death, MI, UA, or stroke

0.98 (0.89–1.08)

0.65

CV death, MI, UA, or stroke

1.02 (0.89–1.17)

0.81

CV death, MI, or stroke

0.86 (0.74–0.99)

0.04a

CV death, MI, or stroke

0.87 (0.78–0.97)

0.01

CV death, MI, or stroke

0.74 (0.58–0.95)

<0.001/0.02a

Cardiovascular death

Primary end-point

1.03 (0.87–1.22)

0.72

Primary end-point

0.85 (0.66–1.10)

0.212

Primary end-point

1.03 (0.89–1.19)

0.71

Primary end-point

0.98 (0.78–1.22)

0.85

Primary end-point

0.62 (0.49–0.77)

< 0.001

Primary end-point

0.78 (0.66–0.93)

0.007

Primary end-point

0.98 (0.65–1.48)

0.92

Myocardial infarction

Primary end-point

0.95 (0.80–1.12)

0.52

Primary end-point

1.08 (0.88–1.33)

0.47

Primary end-point

0.95 (0.81–1.11)

0.49

Primary end-point

1.03 (0.87–1.22)

0.71

Primary end-point

0.87 (0.70–1.09)

0.23

Primary end-point

0.86 (0.73–1.00)

0.046

Primary end-point

0.74 (0.51–1.08)

0.12

Stroke

Primary end-point

1.11 (0.88–1.39)

0.38

Primary end-point

0.91 (0.55–1.50)

0.71

Primary end-point

0.97 (0.79–1.19)

0.76

Primary end-point

1.12 (0.79–1.58)

0.54

Primary end-point

1.18 (0.89–1.56)

0.26

Primary end-point

0.86 (0.71–1.06)

0.16

Primary end-point

0.61 (0.38–0.99)

0.04

Hospitalization for unstable angina

Secondary end-point

1.19 (0.89–1.60)

0.24

Secondary end-point

0.90 (0.60–1.37)

0.632

Primary end-point

0.90 (0.70–1.16)

0.42

Primary end-point

1.11 (0.47–2.62)

0.81

Secondary end-point

0.99 (0.74–1.34)

0.97

Extended

Primary end-point

0.98 (0.76–1.26)

0.87

Extended primary end-point

0.82 (0.47–1.44)

0.49

Hospitalization for heart failure

Secondary end-point

1.27 (1.07–1.51)

0.007

Extended

Primary end-point

1.19 (0.90-1.58)

0.220

Secondary end-point

1.00 (0.83–1.20)

0.98

Secondary end-point

0.96 (0.75-1.23)

0.75

Secondary end-point

0.65 (0.50–0.85)

0.002

Extended

Primary end-point

0.87 (0.73-1.05)

0.14

Extended primary end-point

1.11 (0.77–1.61)

0.57

 

Event rate (%) active group

Event rate (%) active group

Event rate (%) active group

Event rate (%) active group

Event rate (%) active group

Event rate (%) active group

Event rate (%) active group

       

No. (%)

p value

No. (%)

p value

No. (%)

p value

No. (%)

p value

No. (%)

p value

No. (%)

p value

No. (%)

p value

Primary composite MACE

7.3

11.3

9.6

13.4

10.5

13.0

6.6

       

Non-cardiovascular endpoints

       

 Renal event

2.0 %

0.46

0.9 %

0.88

1.5 %

1.6 %

5.2 %

5.7 %

3.8 %

       

 Acute pancreatitis

0.3 %

0.17

0.4 %

0.5

0.3 %

0.12

0.2 %

0.3 %b

0.4 %

0.44

0.54 %

       

 Hypoglycemia events

0.5 %

0.33

0.7 %

0.86

1.9 %

0.33

0.6 %

1.3 %

3.3 %

0.02

22.4 %c

       
  1. aSuperiority test
  2. bAverage across all age ranges
  3. cSevere hypoglycemia as defined by ADA
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Cardiovascular Diabetology

ISSN: 1475-2840