フィネレノンによる原発性アルドステロン症患者の有効性と安全性：多施設共同前向き研究

Finerenone is a novel nonsteroidal mineralocorticoid receptor antagonist. However, robust evidence about its efficacy and safety in primary aldosteronism is scarce.

In this prospective, multicenter, single-arm, and exploratory trial, we enrolled adults (aged ≤75 years) with primary aldosteronism, an office blood pressure (BP) ranging from 140 to 180/90 to 120 mm Hg, and an estimated glomerular filtration rate ≥60 mL/min per 1.73 m². Eligible patients received finerenone (20-40 mg/d) treatment for 12 weeks. The primary outcome was the change in daytime systolic BP at 12 weeks.

Fifty-seven patients were ultimately treated. Per-protocol analysis revealed that finerenone treatment significantly reduced mean daytime systolic BP (-6.69±1.60 mm Hg; P<0.001) and diastolic BP (-4.55±1.06 mm Hg; P<0.001) according to ambulatory monitoring. Mean office BP decreased even more substantially (systolic BP, -15.58±1.69 mm Hg; diastolic BP, -8.61±1.02 mm Hg; both P<0.001). The mean increase in serum potassium concentration was 0.39±0.05 mmol/L, and 94.5% of patients exhibited a normal concentration after 12 weeks of treatment (versus baseline 61.8%; P<0.001). Plasma renin activity increased, and 32.7% of patients exhibited a plasma renin activity concentration ≥1 ng/mL per h. According to the Primary Aldosteronism Medical Treatment Outcome criteria, 29.1% and 20.0% of patients achieved complete biochemical and clinical responses, respectively. Treatment was well tolerated.

This study demonstrated the efficacy and safety of finerenone in the treatment of primary aldosteronism, supporting its use as a potential alternative therapy for the condition. Nevertheless, further prospective and head-to-head randomized controlled trials are essential to establish finerenone as a viable substitute for spironolactone.

URL: https://www.clinicaltrials.gov; Unique identifier: NCT06381323.