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New data on finerenone for the protection of patients with chronic kidney disease and type 2 diabetes from cardiovascular events and kidney disease progression is published in NEJM.- Bayer

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Published:29th Aug 2021
Bayer announced that detailed results from the Phase III FIGARO-DKD study demonstrated that compared with placebo, Kerendia (finerenone) – a first-in-class nonsteroidal mineralocorticoid receptor antagonist (MRA) – significantly reduced the risk of the composite primary endpoint of time to first occurrence of cardiovascular (CV) death or nonfatal CV events (myocardial infarction, stroke or heart failure hospitalization) by 13% (relative risk reduction, HR 0.87 [95% CI, 0.76-0.98; P=0.0264]) over a median duration of follow-up of 3.4 years when added to maximum tolerated labeled dose of angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB) in adults with chronic kidney disease (CKD) associated with type 2 diabetes (T2D).

The reduction in the CV composite outcome was primarily driven by hospitalization due to heart failure. In this study, the incidence of the key secondary endpoint, a composite of time to kidney failure, a sustained decrease of eGFR of at least 40% from baseline over a period of at least four weeks, or renal death was lower with finerenone than with placebo, affecting 350 (9.5%) and 395 (10.8%) patients, respectively. However, the difference was not statistically significant (HR 0.87 [95% CI, 0.76-1.01; P=0.0689]) over a median duration of follow-up of 3.4 years.

In the FIDELIO-DKD study, finerenone reduced the incidence of the primary composite endpoint of a sustained decline in eGFR of of at least 40%, kidney failure or renal death (HR 0.82 [95% CI, 0.73-0.93; P=0.001]). The treatment effect reflected a reduction in a sustained decline in eGFR of of at least 40% and progression to kidney failure. There were few renal deaths during the trial. In FIGARO-DKD, safety and tolerability profile were generally consistent with that of previously reported FIDELIO-DKD results.

Overall, hyperkalemia-related adverse events occurred more often in patients receiving finerenone compared with placebo (10.8% and 5.3%, respectively). Hospitalization due to hyperkalemia for the finerenone group was 0.6% versus <0.1% in the placebo group, and there was no hyperkalemia-related death in either treatment group. treatment was discontinued due to hyperkalemia in 1.2% of patients treated with finerenone compared to 0.4% in the placebo group.>

FIDELITY is a meta-analysis of the largest Phase III program to evaluate the occurrence of progression of kidney disease as well as fatal and nonfatal CV events in >13,000 adult patients with CKD associated with T2D. In this prespecified exploratory meta-analysis, finerenone reduced the risk of the composite CV outcome of time to CV death, nonfatal myocardial infarction, nonfatal stroke or hospitalization for heart failure by 14% compared with placebo. The composite CV outcome occurred in 825 (12.7%) patients receiving finerenone and 939 (14.4%) patients receiving placebo (HR 0.86 [95% CI, 0.78–0.95]), with a number needed to treat of 46 at 36 months. The reduction in the CV composite outcome was primarily driven by hospitalization for heart failure. Cardiovascular death and nonfatal myocardial infarction were directionally consistent with the CV composite outcome. The composite kidney outcome of time to first onset of kidney failure, sustained at least 57% decrease in eGFR from baseline over a minimum 4 weeks, or renal death occurred in 360 (5.5%) patients receiving finerenone and 465 (7.1%) receiving placebo (HR 0.77 [95% CI, 0.67–0.88]).

In FIDELIO-DKD, this exploratory composite kidney outcome of kidney failure, sustained decrease in eGFR by 57% or more from baseline, or renal death occurred in 252 (8.9%) patients and 326 (11.5%) patients in the finerenone and placebo groups, respectively (HR 0.76 [95% CI, 0.65–0.90]). In FIGARO-DKD, this exploratory composite kidney outcome of kidney failure, sustained decrease in eGFR by 57% or more from baseline, or renal death occurred in 108 (2.9%) patients and 139 (3.8%) patients in the finerenone and placebo groups, respectively (HR 0.77 [95% CI, 0.60–0.99]). Kerendia is not indicated to reduce the risk of renal death.

See: "Cardiovascular Events with Finerenone in Kidney Disease and Type 2 Diabetes." Bertram Pitt et al. NEJM August 28, 2021 DOI: 10.1056/NEJMoa2110956

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Condition: Diabetes Type 2 and Kidney Disease
Type: drug

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