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Table 2 CVOTs completed in 2018: comparison of results vs. placebo

From: Report from the 4th Cardiovascular Outcome Trial (CVOT) Summit of the Diabetes & Cardiovascular Disease (D&CVD) EASD Study Group

Cardiovascular endpoints

CARMELINA

Harmony Outcomes

DECLARE-TIMI 58

ODYSSEY OUTCOMES

Class

HR (95% CI)

p-value

Class

HR (95% CI)

p-value

Class

HR (95% CI)

p-value

Class

HR (95% CI)

p-value

Primary composite MACE

CV death, non-fatal MI or non-fatal stroke

1.02 (0.89–1.17)

p < 0.001a

p = 0.74b

CV death, non-fatal MI or non-fatal stroke

0.78 (0.68–0.90)

p < 0.0001a

p = 0.0006b

CV death, non-fatal MI or non-fatal stroke

0.93 (0.84–1.03)

p = 0.17b

CV death, non-fatal MI, non-/fatal stroke or unstable angina

0.85 (0.78–0.93)

p < 0.001

Cardiovascular death

Exploratory outcome

0.96 (0.81–1.14) p = 0.63

Secondary endpoint

0.93 (0.73–1.19)

p = 0.578

Primary endpoint

0.83 (0.73–0.95)c

p = 0.005c

Secondary endpoint

0.88 (0.74–1.05)

Myocardial infarction

Exploratory outcome

1.12 (0.90–1.14)

p = 0.30

Secondary endpoint

0.75 (0.61–0.90)

p = 0.003

Primary endpoint

0.89 (0.77–1.01)

Additional endpoint

0.86 (0.77–0.96)

Stroke

Exploratory outcome

0.88 (0.63–1.23)

p = 0.45

Secondary endpoint

0.86 (0.66–1.14)

p = 0.300

Primary endpoint

1.01 (0.84–1.21)

Additional endpoint

0.73 (0.57–0.93)

Hospitalisation for unstable angina

Exploratory outcome

0.87 (0.57–1.31)

p = 0.50

Additional endpoint

0.61 (0.41–0.92)

Hospitalisation for heart failure

Exploratory outcome

0.90 (0.74–1.08)

p = 0.26

Primary endpoint

0.73 (0.61–0.88)

Additional endpoint

0.98 (0.79–1.20)

 

Event rate (%) active group

Event rate (%) active group

Event rate (%) active group

Event rate (%) active group

Primary composite MACE

12.4

4.57

8.8

9.5

 

No. (%)

p-value

No. (%)

p-value

No. (%)

p-value

No. (%)

p-value

Renal event

6.6d

0.87

6

0.76e

Acute pancreatitis

0.3

< 1

Severe hypoglycaemic events

3.0

1

0.7

0.02

  1. ap-value for non-inferiority
  2. bp-value for superiority
  3. cCardiovascular death or hospitalisation for heart failure
  4. dSustained ESRD, death due to kidney failure, or sustained decrease of ≥ 50% in eGFR from baseline
  5. eComposite renal outcome