2.4.2-Efficacy

For your adult patients with HF LVEF ≥40%

KERENDIA helps protect your patients’ hearts by reducing the risk of CV death, hospitalization for HF, and urgent HF visits

Primary endpoint

Subgroup analysis

ON TOP OF BACKGROUND HF THERAPIES

PRIMARY COMPOSITE ENDPOINT^1,3

16% RRR

vs placebo

RR=0.84
(95% CI: 0.74-0.95)

P=0.007

Sensitivity analysis^1,15*

Time to first HF event^† or CV death at 36 months

ARR=3.5%; NNT=29 (95% CI: 17-91)

Secondary composite endpoint

HF hospitalizations and urgent HF visits were reduced by 18% in patients receiving KERENDIA vs placebo^†

CV outcomes in CKD with T2D

*In a prespecified sensitivity analysis, the time to first HF event or CV death was evaluated at month 36 to calculate NNT and ARR, as determined by the FINEARTS-HF Steering Committee (RR=0.84 [95% CI: 0.76-0.94]).^† Composite of total HF events: 18% RRR vs placebo (RR=0.82 [95% CI 0.71-0.94]; P=0.006).

ARR=absolute risk reduction; CI=confidence interval; CV=cardiovascular; HF=heart failure; HF LVEF=heart failure with left ventricular ejection fraction; NNT=number needed to treat; RR=relative reduction; RRR=relative risk reduction.

Treatment effect with or without baseline SGLT2i use^1,48

Additional subgroup results

*Mean cumulative events for the composite of CV death and total HF events. An HF event was defined as a first or recurrent hospitalization for heart failure or urgent visit for heart failure.

ARR=absolute risk reduction; CI=confidence interval; eGFR=estimated glomerular filtration rate; HF=heart failure; LVEF=left ventricular ejection fraction; NYHA=New York Heart Association; PY=patient year; RR=relative reduction; RRR=relative risk reduction; SGLT2i=sodium-glucose cotransporter 2 inhibitor.

Trial Design Efficacy Safety

IMPORTANT SAFETY INFORMATION AND INDICATIONS

CONTRAINDICATIONS:

Hypersensitivity to any component of this product
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 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.
Worsening of Renal Function in Patients with Heart Failure: KERENDIA can cause worsening of renal function in patients with heart failure. Rarely, severe events associated with worsening renal function, including events requiring hospitalization, have been observed

Measure eGFR in all patients before initiation of treatment or with dose titration of KERENDIA and dose accordingly. Initiation of KERENDIA in patients with heart failure and an eGFR <25 mL/min/1.73 m² is not recommended. Measure eGFR periodically during maintenance treatment with KERENDIA in patients with heart failure. Consider delaying up-titration or interrupting treatment with KERENDIA in patients who develop clinically significant worsening of renal function

MOST COMMON ADVERSE REACTIONS:

CKD associated with T2D: From the pooled data of FIDELIO-DKD and FIGARO-DKD, 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%), and hyponatremia (1.3% vs 0.7%).
HF LVEF ≥40%: From FINEARTS-HF, the adverse reactions reported in ≥1% of patients on KERENDIA and more frequently than placebo were hyperkalemia (9.7% vs 4.2%), hypotension (7.6% vs 4.7%), and hyponatremia (1.9% vs 0.9%). Events related to worsening renal function were reported more frequently in the KERENDIA group (18%) compared with placebo (12%).

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.
Sensitive CYP2C8 Substrates at KERENDIA 40mg: Monitor patients more frequently for adverse reactions caused by sensitive CYP2C8 substrates if KERENDIA 40mg is co-administered with such substrates, since minimal concentration changes may lead to serious adverse reactions.

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).

INDICATIONS:

KERENDIA (finerenone) is indicated to reduce the risk of:

sustained estimated glomerular filtration rate (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) (10mg, 20mg tablets)
cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adult patients with heart failure with left ventricular ejection fraction (HF LVEF) ≥40% (10mg, 20mg, 40mg tablets)

Please see the full Prescribing Information for KERENDIA.

CI=confidence interval; CKD=chronic kidney disease; CV=cardiovascular; eGFR=estimated glomerular filtration rate; HR=hazard ratio; RR=relative reduction; RRR=relative risk reduction; T2D=type 2 diabetes; UACR=urine albumin-to-creatinine ratio.

REFERENCES

KERENDIA helps protect your patients’ hearts by reducing the risk of CV death, hospitalization for HF, and urgent HF visits

Treatment effect with or without baseline SGLT2i use^1,48

Primary CV composite endpoint

Exploratory analysis¹

Primary renal composite endpoint

Exploratory analysis¹

Secondary CV composite endpoint

REFERENCES

KERENDIA helps protect your patients’ hearts by reducing the risk of CV death, hospitalization for HF, and urgent HF visits

Treatment effect with or without baseline SGLT2i use1,48

KERENDIA for CKD associated with T2D: efficacy and safety overview

Primary CV composite endpoint

Exploratory analysis1

Secondary renal composite endpoint

Primary renal composite endpoint

Exploratory analysis1

Secondary CV composite endpoint

Safety: pooled data FIGARO-DKD and FIDELIO-DKD1

KERENDIA showed a consistent treatment effect across all prespecified subgroups​

Select prespecified exploratory subgroups

Treatment effect with or without baseline SGLT2i use^1,48

Exploratory analysis¹

Exploratory analysis¹

Safety: pooled data FIGARO-DKD and FIDELIO-DKD¹

KERENDIA showed a consistent treatment effect across all prespecified subgroups