Long‐term weight loss and cardiorenal outcomes by baseline BMI in the VERTIS CV trial

Figures

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  FIGURE 1. Change in body weight in the overall population and according to baseline BMI for absolute change (kg) at Year 3 (A) and Year 5 (B) and percentage change at Year 3 (C) and Year 5 (D). LS mean change was evaluated using a constrained longitudinal data analysis model applied to each BMI subgroup separately; the model included fixed effects for treatment, visit (categorical), baseline estimated glomerular filtration rate (eGFR, continuous), baseline BMI (continuous) and treatment by visit interaction. BL, baseline; BMI, body mass index; CI, confidence interval; ERTU, ertugliflozin; LS, least squares; PBO, placebo.

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  FIGURE 2. Placebo‐adjusted LS mean difference in absolute change in body weight (kg) over time by baseline BMI for ertugliflozin (pooled doses). LS mean difference based on RMANCOVA model that adjusts for baseline, treatment, time, baseline A1C, baseline eGFR (continuous), subgroup, treatment‐by‐subgroup interaction and treatment‐by‐subgroup‐by‐time interaction. BL, baseline; BMI, body mass index; CI, confidence interval; ERTU, ertugliflozin; LS, least squares; PBO, placebo.

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  FIGURE 3. Proportion of participants with body weight reduction ≥5% in the overall population and according to baseline BMI at (A) Year 3 and (B) Year 5, and body weight reduction ≥10% at (C) Year 3 and (D) Year 5. Logistic regression was used to determine the odds ratio (95% CI) of achieving body weight reductions of ≥5% and ≥10% with ERTU relative to PBO; analysis was adjusted for baseline BMI (continuous) and baseline eGFR (continuous). If there were no body weight data at the specified timepoint, data were imputed as “not at goal”, that is, weight reduction <5% (or 10%). BMI, body mass index; CI, confidence interval; ERTU, ertugliflozin; PBO, placebo.

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  FIGURE 4. Forest plot of CV outcomes and kidney composite (sustained 40% decline in eGFR, chronic kidney dialysis/transplantation or death from kidney causes) in the overall population and by baseline BMI subgroup. aHazard ratio for ertugliflozin versus placebo, based on the stratified Cox proportional hazards model that included treatment, subgroup and treatment‐by‐subgroup interaction as explanatory factors and randomization cohort category as a stratification factor. bInteraction p‐value for the two level treatment group (all ertugliflozin versus placebo) for BMI subgroups. BMI, body mass index; CV, cardiovascular; eGFR, estimated glomerular filtration rate; HHF, hospitalization for heart failure; MACE, major adverse cardiovascular events.