Finerenone improves outcomes in patients with mild-to-moderate kidney
disease and diabetes

Date:
August 30, 2021
Source:
European Society of Cardiology
Summary:
Finerenone reduces the risk of cardiovascular morbidity and
mortality in patients with mild-to-moderate kidney disease and
type 2 diabetes.

Diabetic kidney disease develops in approximately 40% of patients
with diabetes and is the leading cause of chronic kidney disease
worldwide.

Some patients progress to end-stage renal disease, but most die
from cardiovascular diseases and infections before needing kidney
replacement therapy.



FULL STORY ========================================================================== Finerenone reduces the risk of cardiovascular morbidity and mortality in patients with mild-to-moderate kidney disease and type 2 diabetes. That's
the finding of late breaking research presented in a Hot Line session
today at ESC Congress 20211 and published in the New England Journal
of Medicine2.


========================================================================== Diabetic kidney disease develops in approximately 40% of patients with
diabetes and is the leading cause of chronic kidney disease worldwide.3
Some patients progress to end-stage renal disease, but most die from cardiovascular diseases and infections before needing kidney replacement therapy.3 The FIDELIO-DKD trial previously reported that finerenone,
a nonsteroidal mineralocorticoid receptor antagonist (MRA), slowed
progression of kidney disease and improved cardiovascular outcomes in
patients with predominantly advanced kidney disease and type 2 diabetes.4 FIGARO-DKD investigated cardiovascular and renal outcomes with finerenone treatment in patients with mild-to-moderate kidney disease and type
2 diabetes.

Regarding the study population, FIGARO-DKD enrolled adults with type
2 diabetes and mild-to-moderate kidney disease5 treated with optimised renin-angiotensin system (RAS) blockade. As finerenone increases serum potassium levels by an average of approximately 0.2 mmol/L, patients had
to have serum potassium 4.8 mmol/L or below at the run-in and screening
visits (but not at randomisation) so that levels could be maintained at
an optimal range for most patients, i.e.

around 5.0 mmol/L or below. Nevertheless, study drug could be continued
up to a potassium level of 5.5 mmol/L. Patients with symptomatic chronic
heart failure with reduced ejection fraction were excluded since steroidal
MRA treatment is a class 1A recommendation and withholding therapy for
the duration of the trial would have been unethical.

A total of 7,437 patients in 48 countries were randomised 1:1 to oral finerenone (10 or 20 mg) or placebo once-daily. The average age was
64.1 years and 69.4% were men. The primary endpoint was a cardiovascular composite of time to cardiovascular death, nonfatal myocardial infarction, nonfatal stroke or hospitalisation for heart failure.

During a median follow-up of 3.4 years, the primary endpoint occurred
in 458 (12.4%) and 519 (14.2%) patients in the finerenone and placebo
groups, respectively. The relative risk of this endpoint was significantly reduced by 13% with finerenone versus placebo (hazard ratio [HR] 0.87; 95% confidence interval [CI] 0.76-0.98; p=0.03). The observed cardiovascular benefit was largely driven by a 29% reduction in hospitalisation for
heart failure.



==========================================================================
The key secondary outcome was a composite of kidney failure, sustained
decrease in estimated glomerular filtration rate (eGFR) by 40% or more
from baseline, or renal death.

This endpoint occurred in 350 (9.5%) and 395 (10.8%) patients in the
finerenone and placebo groups, respectively (HR 0.87; 95% CI 0.76-1.01; p=0.07).

Regarding other secondary outcomes, the composite of kidney failure,
sustained decrease in eGFR by 57% or more from baseline, or renal death occurred in 108 (2.9%) and 139 (3.8%) patients in the finerenone and
placebo groups, respectively (HR 0.77; 95% CI 0.60-0.99). End-stage kidney disease occurred in 32 (0.9%) and 49 (1.3%) patients in the finerenone
and placebo groups, respectively (HR 0.64; 95% CI 0.41-<1.00).

Regarding safety, the overall frequency of adverse events did not differ between groups. Hyperkalaemia was increased with finerenone (10.8%)
compared to placebo (5.3%), but subsequent discontinuation of study drug
was low (1.2% with finerenone versus 0.4% with placebo).

Study author Professor Bertram Pitt of the University of Michingan, Ann
Arbor, US saif : Finerone improved cardiovascular outcomes in patients
with mild-to- moderate kidney disease and type 2 diabetes treated
with optimised RAS blockade and with well-controlled blood pressure and diabetes. The benefits of finerenone were consistent across eGFR and urine albumin-to-creatinine ratio (UACR) categories. Together with FIDELIO-DKD,
the results support the use of finerenone to improve cardiorenal outcomes across the spectrum of kidney disease and type 2 diabetes." Notes


========================================================================== 1FIGARO-DKD: finerenone in patients with chronic kidney disease and type
2 diabetes.

2Pitt B et al. Cardiovascular Events with Finerenone in Kidney Disease and
Type 2 Diabetes (FIGARO-DKD) N Engl J Med. 10.1056/NEJMoa2110956 3Alicic
RZ, Rooney MT, Tuttle KR, et al. Diabetic kidney disease: challenges,
progress, and possibilities. Clin J Am Soc Nephrol. 2017;12:2032-2045.

4Bakris GL, Agarwal R, Anker SD, et al. Effect of finerenone
on chronic kidney disease outcomes in type 2 diabetes. N Engl J
Med. 2020;383:2219-2229.

5Mild-to-moderate kidney disease was defined as: urine
albumin-to-creatinine ratio (UACR) >=30-<300 mg/g and estimated glomerular filtration rate (eGFR) >=25-<=90 mL/min/1.73m2 or UACR >=300-<=5000 mg/g
and eGFR >=60 mL/min/1.73m2.

========================================================================== Story Source: Materials provided by European_Society_of_Cardiology. Note: Content may be edited for style and length.


========================================================================== Journal Reference:
1. Bertram Pitt, Gerasimos Filippatos, Rajiv Agarwal, Stefan D. Anker,
George L. Bakris, Peter Rossing, Amer Joseph, Peter Kolkhof,
Christina Nowack, Patrick Schloemer, Luis M. Ruilope. Cardiovascular
Events with Finerenone in Kidney Disease and Type 2 Diabetes. New
England Journal of Medicine, 2021; DOI: 10.1056/NEJMoa2110956 ==========================================================================

Link to news story: https://www.sciencedaily.com/releases/2021/08/210830100017.htm

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