The use of composite endpoints in cardiovascular outcome trials for diabetes: A review of 22 randomized clinical trials published since 2008
Authors' conclusion
To avoid misinterpretation, clinicians and regulatory authorities should be careful when interpreting the results of trials, of which the main outcomes are CEs.
Study context
- Population
- RCTs assessing CV outcomes in patients with T2D, from 2008 onwards, identified from CVOT Summit reports of the Diabetes & CV Disease EASD Study Group22 trials
- Outcome
- Composite:
- Endpoints
- Gradient of importance
Methodological detailsMean 8098 patients randomised per trial; mean duration 33 months (SD 16)
- Mean 8098 patients randomised per trial; mean duration 33 months (SD 16)
Pooled result
As reported in the abstract
No gradient of importance across outcomes, patient perspective
22 of 22
100%
Small gradient of importance, clinician perspective
22 of 22
100%
Results not clearly presented as based on a CE
10 of 22
45%
Further pooled results
Gradient of treatment effect and events across outcomes
- Moderate to large gradient of effect among reporting studies
- 9 of 18 (50%)
- Assessment of events available
- 15 of 22 studies (68%)
- Gradient of effect >5% points between included outcomes
- three of 15 (20%)
Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.
Original publication
The use of composite endpoints in cardiovascular outcome trials for diabetes: A review of 22 randomized clinical trials published since 2008. Diabetes Obes Metab. Published 2 September 2024. doi:10.
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