Additive effects of dapagliflozin and finerenone on albuminuria in non-diabetic CKD: an open-label randomized clinical trial.

Abstract

Listen

Translate article

Dapagliflozin and finerenone reduce albuminuria and slow CKD progression, but additive effects remain unstudied. We compared their individual and combined efficacy and safety in patients with non-diabetic CKD. In an open-label, randomized clinical trial, we included patients aged 18-80 on maximal tolerated ACE inhibitor or angiotensin receptor blocker with eGFR 25-45mL/min/1,73m2 and albuminuria 150-2000mg/g. Participants received either finerenone 20mg/day or dapagliflozin 10mg/day for four weeks, followed by combination therapy for four weeks. Data were collected at baseline, 4 and 8 weeks. Twenty patients (10 per group) with a mean mGFR of 34mL/min/1,73 m2 and a mean urine albumin creatinine ratio (UACR) of 469mg/g were included. Finerenone alone or in addition to dapagliflozin resulted in -24% (95% CI, -36% to -11%) and -34% (95% CI, -47% to -18%) change in UACR, respectively. Dapagliflozin alone or in addition to finerenone resulted in -8% (95% CI, -22 to 9%) and -10% (95% CI, -28% to 12%) change in UACR, respectively. Overall, UACR change after 8 weeks was -36% (95% CI, -46% to -24%). After 8 weeks, systolic blood pressure and mGFR were reduced by 10mmHg (95% CI, 6-13mmHg) and 7mL/min/1,73 m2 (95% CI, 5-8mL/min/1,73 m2). Adverse effects were minimal. The combination of finerenone and dapagliflozin was safe and significantly reduced albuminuria. The effect of combination therapy was at least equal to the calculated, combined effect of each of the drugs, suggesting an additive effect on albuminuria. Larger studies assessing long-term effects and safety are warranted.