The composite outcome was the occurrence of death and CV events during follow-up.
Bivariate and multivariable Cox proportional hazard regression models (Table 2, Models 1 and 2, respectively) were used to estimate hazard ratios (HR) and 95% confidence intervals (CI) of death and CV events, as combined and separate outcomes, as a function of adherence categories.
The number of other CV events including: additional CV events occurring while in hospital; CV events not requiring hospitalization; CV deaths; and CV procedures were similar in the two treatment groups.
The prognostic significance of diabetic retinopathy (DR) for death and cardiovascular (CV) outcomes is debated.
In total, only a single serious gastrointestinal event, one symptomatic ulcer, one death and four CV events were reported.
The Canadian study of Prediction of Risk and Evolution to Dialysis, Death and Interim CV events over Time (CanPREDDICT) was established in 2008 to address these questions of interest.
Inclusion in the trial of high CV disease risk subjects resulted in an event rate (first coprimary outcome: composite of CV death, myocardial infarction, stroke, and CV death) of ∼3% per year with no difference in the two treatment groups (2.94 vs. 2.85/100 person-years; HR 1.02 [95% CI 0.94 1.11]; P = 0.63).
Previous trials of SGLT-2 inhibitors showed reductions in cardiovascular (CV) events, including CV death and hospitalization for heart failure, and ischemic events in patients with atherosclerotic cardiovascular disease (ASCVD).
The primary outcome of interest was the incidence of CV disease including fatal and/or non-fatal myocardial infarction (MI), fatal and/or non-fatal stroke, CV death, and major acute coronary event (MACE) as defined by the studies reviewed.
The latter method accounted for CV death and other death as competing risks.
