Post-Hoc Analysis on the Effects of Vicadrostat/Empagliflozin by CKD Severity/Hypertension Status.

INTRODUCTION

This phase 2 trial (NCT05182840) assessed the efficacy and safety of the aldosterone synthase inhibitor, vicadrostat, alone or with empagliflozin, in people with chronic kidney disease (CKD). These post hoc analyses assessed the effects of vicadrostat, with or without background empagliflozin, on albuminuria across a range of CKD severity and hypertension (HTN) status.

METHODS

The analysis set included 503 participants who had urine albumin-to-creatinine ratio (UACR) measures available at baseline and week 14. Subgroup analyses of the effects of vicadrostat, given alone or with empagliflozin, were performed by the presence or absence of uncontrolled HTN (defined as blood pressure [BP] ≥ 140/90 mm Hg and use of ≥2 classes of antihypertensive medication), kidney failure risk equation (KFRE) 4-factor 5-year risk < 5% versus ≥ 5%, Kidney Disease: Improving Global Outcomes (KDIGO) moderate-to-high risk versus very high risk, and diuretic use at baseline.

RESULTS

UACR was reduced with vicadrostat, with or without empagliflozin background, across all subgroup analyses (adjusted mean reduction with 10 mg and 20 mg vicadrostat dose groups: 25%-55% vs. 24%-51% in the overall study). UACR reductions were consistent in participants irrespective of KDIGO risk group, KFRE subgroup, presence or absence of uncontrolled HTN at baseline or diuretic use.

CONCLUSION

The effects of vicadrostat on albuminuria reduction, with or without empagliflozin, were generally consistent irrespective of CKD stage and kidney risk as scored using KDIGO or the KFRE, HTN status, or use of diuretics.