Abstract 9295: Ertugliflozin Has Favorable Effects on Kidney Outcomes in Patients With Baseline Evidence of Heart Failure in VERTIS CV

Abstract

Background: Data from VERTIS CV (NCT01986881) were analyzed to study the effect of ertugliflozin on kidney outcomes in patients with and without baseline evidence of HF. Methods: Patients with type 2 diabetes mellitus and ASCVD were randomized (1:1:1) to ertugliflozin 5 or 15 mg (both doses pooled for analyses) or placebo. Subgroups were defined by baseline history of HF or a pre-randomization left ventricular ejection fraction (EF) ≤45%. eGFR over time, total 5-year eGFR slopes and Cox proportional hazards for time to first event of a kidney composite of sustained ≥40% decrease from baseline eGFR, chronic kidney replacement therapy, or kidney death were assessed. Results: At baseline, 2439 (29.6%) had a history of HF or EF ≤45% (HF) and 5807 (70.4%) had no evidence of HF (no HF). Compared with placebo, ertugliflozin treatment resulted in a slower rate of eGFR decline in both subgroups; total placebo-adjusted 5-year eGFR slope (mL/min/1.73 m 2 /year [95% CI]): 0.96 (0.67, 1.24) and 0.95 (0.76, 1,14) for the HF and no HF subgroups, respectively (Figure 1). The HF subgroup had a higher event rate for the composite kidney outcome than the no HF subgroup. Hazard ratios (95% CI) for ertugliflozin for reducing the risk of the composite kidney outcome did not differ significantly across the two subgroups; 0.53 (0.33, 0.84) and 0.76 (0.53, 1.08) for the HF and no HF subgroups, respectively ( P interaction =0.22) (Figure 2). Conclusion: In VERTIS CV, patients with HF at baseline had a notably faster rate of eGFR decline that is unlikely to be explained by the slightly lower baseline eGFR in that group. The effects of ertugliflozin on kidney outcomes did not differ between the two groups stratified by baseline HF.