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Table 2 CVOTs completed in 2019: comparison of results

From: Report from the 5th cardiovascular outcome trial (CVOT) summit

Cardiovascular endpoints

CAROLINA [18]

PIONEER-6 [20]

REWIND [19]

Class

HR (95% CI)

p-value

Class

HR (95% CI)

p-value

Class

HR (95% CI)

p-value

Primary composite outcome

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

0.98 (0.84–1.14)

p < 0.001 (non-inferiority)

p = 0.76 (superiority)

Death from CV causes (including undetermined causes of death), non-fatal MI, non-fatal stroke

0.79 (0.57–1.11)

p < 0.001 (non-inferiority)

p = 0.17 (superiority)

Death from CV causes or unknown causes, non-fatal MI, non-fatal stroke

0.88 (0.79–0.99)a

p = 0.026 (superiority)

Cardiovascular death

Secondary or tertiary outcome

1.00 (0.81–1.24)

Secondary outcomeb

0.51 (0.31–0.84)b

Secondary outcome

0.91 (0.78–1.06)

p = 0.21

Myocardial infarction (fatal and non-fatal)

Secondary or tertiary outcome

1.03 (0.82–1.29)

Non-fatal MI

Secondary outcome

1.18 (0.73–1.90)

Secondary outcome

0.96 (0.79–1.15)

p = 0.63

Stroke (fatal and non-fatal)

Secondary or tertiary outcome

0.86 (0.66–1.12)

Non-fatal stroke Secondary outcome

0.74 (0.35–1.57)

Secondary outcome

0.76 (0.62–0.94)

p = 0.010

Hospitalisation for unstable angina

Secondary or tertiary outcome

1.07 (0.74–1.54)

Secondary outcome

1.56 (0.60–4.01)

Secondary outcome

1.14 (0.84–1.54)

p = 0.41

Hospitalisation for heart failure

Secondary or tertiary outcome

1.21 (0.92–1.59)

Secondary outcome

0.86 (0.48–1.55)

Secondary outcome

0.93 (0.77–1.12)

p = 0.46

All-cause death

Secondary or tertiary outcome

0.91 (0.78–1.06)

Secondary outcome

0.51 (0.31–0-84)

Secondary outcome

0.90 (0.80–1.01)

p = 0.067

Other outcomes

4P-MACEd Key secondary endpoint

0.99 (0.86–1.14)

Expanded composite outcomec

0.82 (0.61–1.10)

Composite microvascular outcome

Eye: 1.24 (0.92–1.68)

p = 0.16

Renal: 0.85 (0.77–0.93)

p = 0.0004

 

Event rate (%) linagliptin vs. glimepiride group

Event rate (%) active vs. placebo group

Event rate (%) active vs. placebo group

Primary composite outcome

11.8 vs. 12.0

3.8 vs. 4.8

12.0 vs. 13.4

Adverse events

No. (%) linagliptin vs. glimepiride group

p-value

No. (%) active vs. placebo group

p-value

No. (%) active vs. placebo group

p-value

Renal event

–

–

2.0 vs. 2.3

–

1.7 vs. 1.9

0.46

Acute pancreatitis

0.5 vs. 0.5

–

0.1 vs. 0.2

–

0.5 vs. 0.3

0.11

Severe hypoglycaemic events

0.3 vs. 2.2e

–

1.4 vs. 0.8

–

1.3 vs. 1.5

0.38

  1. aAfter accounting for α = 0.009 spent on the primary outcome for the interim analysis, the α for the final analysis is 0.0467 [HR 0.88 (95.33% CI 0.79–0.99)]
  2. bDeath from cardiovascular causes
  3. cDeath from cardiovascular causes, non-fatal myocardial infarction, non-fatal stroke, unstable angina resulting in hospitalization, or heart failure resulting in hospitalization
  4. dCV death, non-fatal myocardial infarction, non-fatal stroke, or hospitalization for unstable angina pectoris
  5. eRequiring the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions