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

From: Correction to: Updates on cardiovascular outcome trials in diabetes

 

SAVOR-TIMI53 [1, 2]

EXAMINE [3, 4]

TECOS [5]

ELIXA [6]

EMPA-REG OUTCOME [7]

LEADER [8]

Class

HR (95% CI)

Class

HR (95% CI)

Class

HR (95% CI)

Class

HR (95% CI)

Class

HR (95% CI)

Class

HR (95% CI)

p value

p value

p value

p value

p value

p value

Cardiovascular endpoints

 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)

0.32

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

 Cardiovascular death

Primary endpoint

1.03 (0.87–1.22)

0.72

Primary endpoint

0.79 (0.60–1.04)

0.10

Secondary endpoint

1.03 (0.89–1.19)

0.71

Primary endpoint

0.98 (0.78–1.22)

0.85

Primary endpoint

0.62 (0.49–0.77)

< 0.001

Primary endpoint

0.78 (0.66–0.93)

0.007

 Myocardial infarction

Primary endpoint

0.95 (0.80–1.12)

0.52

Primary endpoint

1.08 (0.88–1.33)

0.47

Secondary endpoint

0.95 (0.81–1.11)

0.49

Primary endpoint

1.03 (0.87–1.22)

0.71

Primary endpoint

0.87 (0.70–1.09)

0.23

Primary endpoint

0.86 (0.73–1.00)

0.046

 Stroke

Primary endpoint

1.11 (0.88–1.39)

0.38

Primary endpoint

0.91 (0.55–1.50)

0.71

Secondary endpoint

0.97 (0.79–1.19)

0.76

Primary endpoint

1.12 (0.79–1.58)

0.54

Primary endpoint

1.18 (0.89–1.56)

0.26

Primary endpoint

0.86 (0.71–1.06)

0.16

 Hospitalization for unstable angina

Secondary endpoint

1.19 (0.89–1.60)

0.24

Secondary endpoint

0.90 (0.60–1.37)

0.632

Secondary endpoint

0.90 (0.70–1.16)

0.42

Primary endpoint

1.11 (0.47–2.62)

0.81

Secondary endpoint

0.99 (0.74–1.34)

0.97

Extended

primary endpoint

0.98 (0.76–1.26)

0.87

 Hospitalization for heart failure

Secondary endpoint

1.27 (1.07–1.51)

0.007

Extended primary endpoint

1.19 (0.90–1.58)

0.220

Secondary endpoint

1.00 (0.83–1.20)

0.98

Secondary endpoint

0.96 (0.75–1.23)

0.75

Secondary endpoint

0.65 (0.50–0.85)

0.002

Extended

primary endpoint

0.87 (0.73–1.05)

0.14

 

Event rate (%) active group

 

Event rate (%) active group

 

Event rate (%) active group

 

Event rate (%) active group

 

Event rate (%) active group

 

Event rate (%) active group

 

 Primary composite MACE

7.3

 

11.3

 

9.6

 

13.4

 

10.5

 

13.0

 
 

No. (%)

p value

 

No. (%)

p value

 

No. (%)

p value

 

No. (%)

p value

 

No. (%)

p value

 

No. (%)

p value

 

Non-cardiovascular endpoints

 Renal event

5.8

0.04

 

0.9

0.88

 

1.4

 

1.6

 

5.2

 

5.7

0.003

 

 Acute pancreatitis

0.3

0.77

 

0.4

0.5

 

0.3

0.07

 

0.2

 

0.3b

 

0.4

0.44

 

 Hypoglycemia events

15.3

< 0.001

 

6.7

0.74

 

2.2

0.33

 

16.6

0.14

 

2.8

 

2.4

0.02

 
 

SUSTAIN 6 [9]

EXSCEL [10]

DEVOTE [11]

CANVAS program [12]

ACE [13]

Class

HR (95% CI)

p value

Class

HR (95% CI)

p value

Class

HR (95% CI)

p value

Class

HR (95% CI)

p value

Class

HR (95% CI)

p value

Cardiovascular endpoints

 Primary composite MACE

CV death, MI, or stroke

0.74 (0.58–0.95)

0.02a

CV death, MI or stroke

0.91 (0.83–1.00)

0.06a

CV death, MI or stroke

0.91 (0.78–1.06)

< 0.001

CV death, MI or stroke

0.86 (0.75–0.97)

0.02a

CV death, MI, stroke, UA and HF

0.98 (0.86–1.11)

0.73

 Cardiovascular death

Primary endpoint

0.98 (0.65–1.48)

0.92

Secondary endpoint

0.88 (0.76–1.02)

Primary endpoint

0.96 (0.76–1.21)

0.71

Primary endpoint

0.87 (0.72–1.06)

Secondary endpoint

0.89 (0.71–1.11)

0.29

 Myocardial infarction

Primary endpoint

0.74 (0.51–1.08)

0.12

Secondary endpoint

0.97 (0.85–1.10)

Primary endpoint

0.85 (0.68–1.06)

0.15

Primary endpoint

0.89 (0.73–1.09)

Secondary endpoint

1.12 (0.87–1.46)

0.38

 Stroke

Primary endpoint

0.61 (0.38–0.99)

0.04

Secondary endpoint

0.85 (0.70–1.03)

Primary endpoint

0.90 (0.65–1.23)

0.50

Primary endpoint

0.87 (0.69–1.09)

Secondary endpoint

0.97 (0.70–1.33)

0.83

 Hospitalization for unstable angina

Extended primary endpoint

0.82 (0.47–1.44)

0.49

Primary endpoint

0.95 (0.68–1.31)

0.74

Secondary endpoint

1.02 (0.82–1.26)

0.87

 Hospitalization for heart failure

Extended primary endpoint

1.11 (0.77–1.61)

0.57

Secondary endpoint

0.94 (0.78–1.13)

Secondary endpoint

0.67 (0.52–0.87)

Secondary endpoint

0.89 (0.63–1.24)

0.48

 

Event rate (%) active group

Event rate (%) active group

Event rate (%) active group

Event rate (%) active group

Event rate (%) active group

 Primary composite MACE

6.6

11.4

8.5

26.9d

14.4

 

No. (%)

p value

No. (%)

p value

No. (%)

p value

No. (%)

p value

No. (%)

p value

Non-cardiovascular endpoints

 Renal event

3.9

55 (0.7)

3.8

19.7d

0.32

 Acute pancreatitis

0.55

26 (0.4)

0.5d

0.63

 Hypoglycemia events

22.4c

247 (3.4)

4.9

< 0.001a

56.0d

0.20

54 (2)

0.95

  1. aSuperiority test
  2. bAverage across all age ranges
  3. cSevere hypoglycaemia as defined by ADA
  4. dNumber of participants per 1000 patient-years