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Table 2 CVOTs terminated in 2015 and published in 2016: comparison of results versus placebo

From: Report from the 2nd Cardiovascular Outcome Trial (CVOT) Summit of the Diabetes and Cardiovascular Disease (D&CVD) EASD Study Group

Cardiovascular endpoints EMPA-REG [4, 5] LEADER [6] SUSTAIN-6 [7]
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 0.86 (0.74–0.99)
0.04*
CV death, MI, or stroke 0.87 (0.78–0.97)
0.01
CV death, MI, or stroke 0.74 (0.58–0.95)
<0.001/0.02*
Cardiovascular death 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 0.87 (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 1.18 (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 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 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
Primary composite MACE Event rate (%)
active group
Event rate (%)
active group
Event rate (%)
active group
10.5 13.0 6.6
Non-cardiovascular endpoints No. (%)
p value
No. (%)
p value
No. (%)
p value
Renal event 5.2 5.7 3.8
Acute pancreatitis 0.3$ 0.4
0.44
0.54
Hypoglycemia events 1.3 3.3
0.02
22.4
  1. * Superiority test; $ average across all age ranges;  Severe hypoglycemia as defined by ADA