Statistical analysis
obesity, congestive heart failure
REGRESSION, OBESITY, CONGESTIVE HEART FAILURE, LEFT VENTRICULAR HYPERTROPHY
All randomized subjects who received at least one dose of trial treatment and had at least one available post-baseline assessment of the primary analysis variable were included in the intention-to-treat (ITT) population (primary analysis sample). Continuous variables are presented by mean and standard deviation for normal distributions and by median and interquartile range for skewed distributions. Discrete variables are described by relative and absolute frequencies.To account for potential differences between groups and to increase statistical power, it was pre-specified that the analysis of study endpoints would be performed by linear regression analysis with the study endpoint as the dependent variable and empagliflozin 10 mg/day versus placebo as predictor, adjusting for age, sex, and baseline value of each outcome parameter. The respective estimates provide the difference of the change scores by groups. To assess the robustness of the potential effect of empagliflozin on the primary study endpoint, sensitivity analyses were performed in the per-protocol sample and in clinically relevant subgroups: stratified by preserved and reduced left ventricular ejection fraction (≥ 55% vs. < 55%), NT-proBNP within and outside the reference range (< 125 pg/ml vs. ≥ 125 pg/ml), presence of congestive heart failure, left ventricular hypertrophy, and obesity, but also level of uric acid, eGFR, and HbA1c. Finally, mediation analysis using linear regression was performed to quantify the contribution of changes in selected biomarkers to the effect of empagliflozin on the 