Type 2 & other diabetes

Time-dependent event accumulation in a cardiovascular outcome trial of patients with type 2 diabetes and established atherosclerotic cardiovascular disease

Cardiovasc DiabetolPublished Secondary analysis of the Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS) randomised trial

Authors' conclusion

In TECOS, the nonfatal event hazard rates were constant over time. Small increases over time in the hazard rate for fatal events would not require complex modelling to predict event accrual, providing confidence in traditional modelling methods for predicting CV outcome trial event rates in this population. The adjudication gap provides a useful metric to monitor within-trial event accrual patterns.

Study context

Population
Patients with T2D and established atherosclerotic CVD in TECOS
Methodological detailscentrally adjudicated events
  • Centrally adjudicated events

Primary result

As reported in the abstract

Hazard rate morphology over time for 7 outcomes:
  • MACE-4
  • Its components
  • All-cause mortality
  • HF hospitalization
· duration of follow-up

Weibull shape parameter, all-cause mortality

1.14

95% CI 1.08–1.21

Weibull shape parameter, cardiovascular (CV) death

1.08

95% CI 1.01–1.16

Further findings

Adjudication gap (time lag between event occurrence and completed adjudication)

Adjudication gap improved over the course of the trial

Original publication

Time-dependent event accumulation in a cardiovascular outcome trial of patients with type 2 diabetes and established atherosclerotic cardiovascular disease. Cardiovasc Diabetol. Published 28 March 2023. doi:10.1186/s12933-023-01802-x

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