ARTS-HF: Finerenone effective, safe in patients hospitalized for worsening HF

LONDON — In patients hospitalized for worsening HF, finerenone and eplerenone yielded similar decreases in the cardiac biomarker NT-proBNP at 90 days, but finerenone was associated with a lower incidence of mortality, CV hospitalization and emergency presentation for worsening HF.

Finerenone is a novel nonsteroidial mineralocorticoid receptor antagonist that has greater receptor selectivity than spironolactone and better receptor affinity than eplerenone in vitro, Gerasimos Filippatos, MD, of Athens University Hospital Attikon, Athens, Greece, said during a press conference at the European Society of Cardiology Congress.

Gerasimos Filippatos

Researchers conducted the phase 2 ARTS-HF study to compare the safety and efficacy of once-daily oral finerenone (Bayer HealthCare AG) with eplerenone in patients with worsening HF, type 2 diabetes and/or chronic kidney disease.

Patients were randomized within 7 days of presentation to the ED with worsening HF, and medication doses were up-titrated during the starting period. The eplerenone group started with 25 mg every other day, increasing to 25 mg daily on day 30, with up-titration to 50 mg daily by day 60. The finerenone groups started with doses ranging from 2.5 mg to 15 mg daily, increasing to 20 mg if blood potassium remained ≤ 5 mmol/L.

Filippatos reported results on 1,055 patients (mean age, 71 years).

At 90 days, a similar proportion of patients achieved the primary endpoint of more than a 30% decrease in NT-proBNP:

37.2% with eplerenone;
30.9% with finerenone 2.5 mg to 5 mg;
32.5% with finerenone 5 mg to 10 mg;
37.3% with finerenone 7.5 mg to 15 mg;
38.8% with finerenone 10 mg to 20 mg; and
34.2% with finerenone 15 mg to 20 mg.

The secondary composite endpoint of all-cause mortality, CV hospitalization or emergency presentation for worsening chronic HF occurred less frequently in patients assigned all doses of finerenone, expect the lowest dose, compared with patients assigned eplerenone. The greatest risk reduction was observed in patients who started treatment with 10-mg finerenone (HR = 0.56; P = .0157). Individual secondary endpoints were also decreased with finerenone vs. eplerenone: all-cause mortality (P = .0262), CV death (P = .0108) and CV hospitalization (P = .0229). “However, this was a phase 2 trial not powered to evaluate this … exploratory endpoint,” Filippatos said.

All doses of finerenone were well-tolerated, and the results showed a similar incidence of treatment-emergent adverse events with finerenone or eplerenone. The mean change in potassium from baseline to 90 days was 0.262 mmol/L in the eplerenone group and ranged from 0.119 mmol/L to 0.202 mmol/L in the finerenone groups. Both treatments were also associated with similar rates of potassium elevation greater than 5.6 mmol/L (4.7% with eplerenone vs. 4.3% with finerenone) and estimated glomerular filtration rate greater than 40% (9.4% eplerenone vs. 9.1% finerenone). – by Katie Kalvaitis

Reference:

Filippatos GS, et al. Hot Line III: Diabetes Mellitus/Pharmacology. Presented at: European Society of Cardiology Congress; Aug. 29-Sept. 2, 2015; London.

Disclosure: The study was sponsored by Bayer. Filippatos reports advising for Bayer HealthCare AG.