In the CV outcomes trial (FIGARO-DKD) of adult patients with CKD associated with T2D*
KERENDIA significantly reduced the risk of CV events on top of an ACEi or ARB1†
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
In the renal outcomes trial§ (FIDELIO-DKD)*
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*
KERENDIA significantly slowed CKD progression on top of an ACEi or ARB1,4†
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
In the CV outcomes trial§ (FIGARO-DKD)*
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
The efficacy of KERENDIA for CV and renal outcomes was evaluated in >13,000 adults with CKD associated with T2D1
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
Renal outcomes trial
CV outcomes trial
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.
INDICATION:
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)
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS:
- Concomitant use with strong CYP3A4 inhibitors
- Patients with adrenal insufficiency
WARNINGS AND PRECAUTIONS:
- Hyperkalemia: KERENDIA can cause hyperkalemia. The risk for developing hyperkalemia increases with decreasing kidney function and is greater in patients with higher baseline potassium levels or other risk factors for hyperkalemia. Measure serum potassium and eGFR in all patients before initiation of treatment with KERENDIA and dose accordingly. Do not initiate KERENDIA if serum potassium is >5.0 mEq/L
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
MOST COMMON ADVERSE REACTIONS:
- From the pooled data of 2 placebo-controlled studies, the adverse reactions reported in ≥1% of patients on KERENDIA and more frequently than placebo were hyperkalemia (14% vs 6.9%), hypotension (4.6% vs 3.9%), and hyponatremia (1.3% vs 0.7%)
DRUG INTERACTIONS:
- Strong CYP3A4 Inhibitors: Concomitant use of KERENDIA with strong CYP3A4 inhibitors is contraindicated. Avoid concomitant intake of grapefruit or grapefruit juice
- Moderate and Weak CYP3A4 Inhibitors: Monitor serum potassium during drug initiation or dosage adjustment of either KERENDIA or the moderate or weak CYP3A4 inhibitor and adjust KERENDIA dosage as appropriate
- Strong and Moderate CYP3A4 Inducers: Avoid concomitant use of KERENDIA with strong or moderate CYP3A4 inducers
USE IN SPECIFIC POPULATIONS:
- Lactation: Avoid breastfeeding during treatment with KERENDIA and for 1 day after treatment
- Hepatic Impairment: Avoid use of KERENDIA in patients with severe hepatic impairment (Child Pugh C) and consider additional serum potassium monitoring with moderate hepatic impairment (Child Pugh B)
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.
