In the CV outcomes trial (FIGARO-DKD) of adult patients with CKD associated with T2D*
Primary composite endpoint consisted of CV death, non-fatal MI, non-fatal stroke, or hospitalization for HF
The treatment effect was mainly driven by an effect on hospitalization for HF, though CV death also contributed.1
Individual components of the composite endpoint were exploratory in nature and not adjusted for multiplicity. KERENDIA is not indicated to reduce the risk of non-fatal stroke.1,2
KERENDIA demonstrated a 14% RRR for the key secondary CV composite endpoint (HR=0.86 [95% CI: 0.75-0.99]; P=0.034). The treatment effect reflected a reduction in CV death, non-fatal MI, and hospitalization for HF.1
In the renal outcomes trial (FIDELIO-DKD) of adult patients with CKD associated with T2D*
Primary composite endpoint consisted of kidney failure,‡ a sustained decline of ≥40% in eGFR, or renal death
The treatment effect reflected a reduction in a sustained decline in eGFR of ≥40% and progression to kidney failure. There were few renal deaths during the trial.1
The secondary composite outcome of kidney failure, sustained eGFR decline of ≥40%, or renal death occurred in 350 patients (9.5%) taking KERENDIA and in 395 patients (10.8%) taking placebo (HR=0.87 [95% CI: 0.76-1.01]). The difference was not statistically significant.3
As published in the New England Journal of Medicine3,5
FIGARO-DKD and FIDELIO-DKD were randomized, double-blind, placebo-controlled, multicenter trials with median follow-up periods of 3.4 and 2.6 years, respectively.1
Baseline trial population characteristics1
ACEi=angiotensin-converting enzyme inhibitor; ACVD=atherosclerotic cardiovascular disease; ARB=angiotensin receptor blocker; BP=blood pressure; CKD=chronic kidney disease; CV=cardiovascular; eGFR=estimated glomerular filtration rate; HbA1c=glycated hemoglobin; HF=heart failure; MI=myocardial infarction; NEJM=New England Journal of Medicine; T2D=type 2 diabetes; UACR=urine albumin-to-creatinine ratio.
KERENDIA is indicated 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 chronic kidney disease (CKD) associated with type 2 diabetes (T2D)
Measure serum potassium periodically during treatment with KERENDIA and adjust dose accordingly. More frequent monitoring may be necessary for patients at risk for hyperkalemia, including those on concomitant medications that impair potassium excretion or increase serum potassium
Please read the Prescribing Information for KERENDIA.
References: 1. KERENDIA (finerenone) [prescribing information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals, Inc.; September 2022. 2. Agarwal R, et al. Eur Heart J. 2022;43(6):474-484. doi:10.1093/eurheartj/ehab777. 3. Pitt B, et al. N Engl J Med. 2021;385(24):2252-2263. doi:10.1056/NEJMoa2110956. 4. Kidney Disease: Improving Global Outcomes (KDIGO) CKD Work Group. Kidney Intl Suppl. 2013;3(1):1-150. doi:10.1038/kisup.2012.73. 5. Bakris GL, et al; FIDELIO-DKD Investigators. N Engl J Med. 2020;383(23):2219-2229. doi:10.1056/NEJMoa2025845.