Statistical analyses
albuminuria, cardiovascular death, kidney disease, diabetes
REGRESSION, SENSITIVITY, DIABETES
Unless stated otherwise, all analyses were performed according to the
intention-to-treat principle. Effects of empagliflozin on annual rate of change
in eGFR were assessed using pre-specified shared parameter models,Sensitivity analyses for annual rate of change in eGFR included the
addition of interactions with other key subgroups (to standardize the
distribution of other characteristics across subgroups), as well as restricting
analyses to on-treatment eGFR measurements and using eGFR measurements based on
local creatinine values. In the surviving UK participants with a 4-week
post-final follow-up blood sample, the effect of stopping study treatment on
mean eGFR (after taking account of any differences in eGFR at final follow-up)
was estimated using linear regression models adjusted for age, sex, prior
diabetes, and uACR as specified in the minimisation algorithm and eGFR at the
final follow-up visit. Effects of empagliflozin on albuminuria used a
pre-specified mixed model repeated measures (MMRM) approach.The proportion of treatment effect for the primary composite outcome of
kidney disease progression or cardiovascular death explained by on-study uACR,
systolic blood pressure (SBP), diastolic blood pressure (DBP) and glycated
hemoglobin (HbA1c) was estimated using the landmark method,Further statistical details are provided in the previously published
data analysis plan and primary report.