How Effective is Finerenone?

How Effective is Finerenone?

FINEARTS-HF was a randomized, double-blind, placebo-controlled, multicenter Phase III trial that enrolled 6001 adult patients with heart failure and LVEF ≥40%, with a median follow-up of 2.7 years. The trial results showed that adding finerenone to standard therapy significantly reduced the composite endpoint of cardiovascular death and total heart failure events. Total heart failure events were defined as first or recurrent hospitalization for heart failure or urgent heart failure visit. Compared with placebo, finerenone reduced the relative risk of total heart failure events by 18% and the relative risk of cardiovascular death by 7%. According to a prespecified sensitivity analysis, at 36 months, the number needed to treat (NNT) to prevent one primary composite endpoint event was a certain number of patients. These data establish finerenone as a core treatment pillar in this patient population.

Consistent Subgroup Efficacy and Background Therapy Synergy

In a prespecified exploratory subgroup analysis, finerenone showed consistent treatment effects across all key subgroups, including different levels of left ventricular ejection fraction, time since most recent heart failure event, eGFR level, and New York Heart Association (NYHA) functional class. Of particular note, finerenone provided consistent benefit regardless of baseline use of sodium-glucose cotransporter 2 inhibitors (SGLT2i). Although the number of patients in the SGLT2i subgroup was limited, the results showed no clear conflict with combination therapy. In addition, consistent efficacy was observed across other subgroups such as age, sex, race, and geographic region. All subgroup analyses are exploratory and the results should be interpreted with caution, but these data support the applicability of finerenone in a broad population of patients with heart failure.

Common Adverse Reactions of Finerenone

In the FINEARTS-HF trial, finerenone was generally well tolerated. Adverse reactions occurring at an incidence of ≥1% and higher than placebo included: hyperkalemia (9.7% vs 4.2%), hypotension (7.6% vs 4.7%), and hyponatremia (1.9% vs 0.9%). Worsening renal function-related events were more common in the finerenone group (18%) than in the placebo group (12%), specifically including renal impairment (7% vs 4%), eGFR decrease (5% vs 4%), acute kidney injury (4% vs 2%), and renal failure (3% vs 2%). Most events were mild to moderate; dose adjustments due to renal function worsening were made in 9% of patients in the finerenone group compared with 4% in the placebo group. Hospitalization for worsening renal function occurred in 2.0% and 1.3% of patients, respectively. An initial small increase in serum creatinine and a small decrease in eGFR may be observed after starting treatment, but these typically stabilize within 4 weeks and are reversible upon discontinuation. The incidence of sex hormone-related adverse reactions (e.g., breast tenderness, uterine bleeding) was similar between the two groups, and the permanent discontinuation rate due to adverse events was also similar (3.2% vs 2.8%).