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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