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Table 2 CVOTs completed in 2019: comparison of results

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

Cardiovascular endpointsCAROLINA [18]PIONEER-6 [20]REWIND [19]
ClassHR (95% CI)
p-value		ClassHR (95% CI)
p-value		ClassHR (95% CI)
p-value
Primary composite outcomeCV-death, non-fatal MI, non-fatal stroke0.98 (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 stroke0.79 (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 stroke0.88 (0.79–0.99)a
p = 0.026 (superiority)
Cardiovascular deathSecondary or tertiary outcome1.00 (0.81–1.24)Secondary outcomeb0.51 (0.31–0.84)bSecondary outcome0.91 (0.78–1.06)
p = 0.21
Myocardial infarction (fatal and non-fatal)Secondary or tertiary outcome1.03 (0.82–1.29)Non-fatal MI
Secondary outcome		1.18 (0.73–1.90)Secondary outcome0.96 (0.79–1.15)
p = 0.63
Stroke (fatal and non-fatal)Secondary or tertiary outcome0.86 (0.66–1.12)Non-fatal stroke Secondary outcome0.74 (0.35–1.57)Secondary outcome0.76 (0.62–0.94)
p = 0.010
Hospitalisation for unstable anginaSecondary or tertiary outcome1.07 (0.74–1.54)Secondary outcome1.56 (0.60–4.01)Secondary outcome1.14 (0.84–1.54)
p = 0.41
Hospitalisation for heart failureSecondary or tertiary outcome1.21 (0.92–1.59)Secondary outcome0.86 (0.48–1.55)Secondary outcome0.93 (0.77–1.12)
p = 0.46
All-cause deathSecondary or tertiary outcome0.91 (0.78–1.06)Secondary outcome0.51 (0.31–0-84)Secondary outcome0.90 (0.80–1.01)
p = 0.067
Other outcomes4P-MACEd Key secondary endpoint0.99 (0.86–1.14)Expanded composite outcomec0.82 (0.61–1.10)Composite microvascular outcomeEye: 1.24 (0.92–1.68)
p = 0.16
Renal: 0.85 (0.77–0.93)
p = 0.0004
 Event rate (%) linagliptin vs. glimepiride groupEvent rate (%) active vs. placebo groupEvent rate (%) active vs. placebo group
Primary composite outcome11.8 vs. 12.03.8 vs. 4.812.0 vs. 13.4
Adverse eventsNo. (%) 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 pancreatitis0.5 vs. 0.5
–		0.1 vs. 0.2
–		0.5 vs. 0.3
0.11
Severe hypoglycaemic events0.3 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
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Cardiovascular Diabetology

ISSN: 1475-2840