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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