Skip to main content

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

22.4â‚­

  1. * Superiority test; $ average across all age ranges; ₭ Severe hypoglycemia as defined by ADA