Bayer Announces FINE-HEART Phase III Pooled Analysis of Finerenone, Missing Primary Endpoint but Demonstrating Significant Benefits in Secondary Outcomes
Bayer
Pharmaceutical Product R&D Developer
On September 1, Bayer announced finerenone at the 2024 European Society of Cardiology Congress.（Finerenone）Phase III Pooled Analysis Study FINE-HEART Latest Data. The data shows that patients receiving finerenone treatment experienced cardiovascular（CV）The incidence of the primary endpoint of death was numerically lower in patients receiving placebo treatment but did not reach statistical significance.
Screenshot source: Bayer official website
FINE-HEART is designed for multiple cardio-renal metabolic conditions(CKM)The largest analysis study on the efficacy and safety of non-steroidal mineralocorticoid receptor antagonist finerenone in patients with chronic kidney disease and type 2 diabetes. This study includes three Phase III trials.FINEARTS-HF, FIDELIO-DKD, and FIGARO-DKDApproximately 19,000 patients with heart failure(HF) /Chronic Kidney Disease(CKD) And Type 2 Diabetes(T2D) Patients, aiming to explore the impact of finerenone on cardiovascular and renal outcomes in HF/CKD and T2D patients.
The pre-specified sensitivity analysis of the primary endpoint in FINE-HEART includesCardiovascular death and undetermined death; The secondary endpoint is a renal composite endpoint, including sustained eGFR decline ≥50%, HF hospitalization, the composite of cardiovascular death or HF hospitalization, new-onset atrial fibrillation, major adverse cardiovascular events, all-cause mortality, all-cause hospitalization, and the composite of all-cause mortality or all-cause hospitalization.
The results showed that during the median follow-up period of 2.9 years, the incidence of cardiovascular death in patients treated with finerenone was compared to placebo,The relative risk was reduced by 11%, but it was not statistically significant.（HR 0.89 [95% CI, 0.78-1.01; p=0.076]）。
Although the primary endpoint of cardiovascular death did not reach statistical significance,However, among the secondary endpoints, finerenone significantly reduced all-cause mortality, cardiovascular and kidney events.Compared with placebo, finerenoneAll-cause mortality reduced by 9%（HR 0.91 [95% CI, 0.84-0.99; p=0.027]）, Time of first occurrence of renal failure, eGFR sustained decline ≥50% from baseline(≥4 weeks)Or renal death, etc.Composite renal endpoint reduced by 20%（HR 0.80 [95% CI, 0.72-0.90; p<0.001]）、HF Hospitalization Rate Decreased by 17%（HR 0.83 [95% CI, 0.75-0.92; p<0.001]）。
The overall results of FINE-HEART indicate that,Finerenone has cardio-renal benefits for a broad population of high-risk patients, including those with cardiovascular, renal, and metabolic diseases.
Finerenone is a non-steroidal mineralocorticoid receptor antagonist.（MRA）, which received U.S. FDA approval in July 2021 to reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure in adult patients with CKD associated with T2D. Finerenone is now approved in more than 90 countries worldwide (including China, Europe, Japan, and the U.S.) for the treatment of adult patients with CKD associated with T2D. According to the Insight database,Finerenone's sales in 2023 were $287 million, a year-on-year increase of 152%.
