Indications
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CKD Associated With T2D
HF LVEF ≥40%

For your adult patients with HF LVEF ≥40%

CHANGE THE COURSE OF HF BY REDUCING
CV RISK1-3

Help your adult patients go further by reducing the risk of hospitalization for HF, urgent HF visits,
and CV death.1

Proven risk reduction

KERENDIA is proven to reduce the risk of CV death, HF hospitalization, and urgent HF visits in adults with HF LVEF ≥40%1

Clinical results
Established safety

KERENDIA was generally well-tolerated in patients with HF LVEF ≥40%1,24

Safety
Addresses key drivers

KERENDIA blocks MR overactivation thought to contribute to sodium and fluid retention, inflammation, fibrosis, and cardiac hypertrophy1,15,16

MOA

CV=cardiovascular; HF=heart failure; HF LVEF=heart failure with left ventricular ejection fraction; MR=mineralocorticoid receptor; MOA=mechanism of action.

For your adult patients with HF LVEF ≥40%

KERENDIA is proven to reduce the risk of CV death, hospitalization for HF, and urgent HF visits1

Trial design: FINEARTS-HF (N=6001) was a randomized, double-blind, placebo-controlled, multicenter, phase 3 trial that evaluated adult patients with HF LVEF ≥40%. The median follow-up period was 2.7 years.1,10*

ON TOP OF BACKGROUND HF THERAPIES

PRIMARY COMPOSITE ENDPOINT1,23

16% RRR

vs placebo

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

P=0.007

Sensitivity analysis24†

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

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

Secondary endpoint

Total HF events (hospitalizations for HF or urgent HF visits) were reduced by 18% in patients received KERENDIA vs placebo
(RR=0.82 [95% CI: 0.71-0.94]; P=0.006)1

*In the FINEARTS-HF trial, HF LVEF ≥40% was defined as HFmrEF or HFpEF.21 †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]).10

ARR=absolute risk reduction; CI=confidence interval; CV=cardiovascular; HF=heart failure; HF LVEF=heart failure with left ventricular ejection fraction; HFmrEF=heart failure with mildly reduced ejection fraction; HFpEF=heart failure with preserved ejection fraction; MRA=mineralocorticoid receptor antagonist; NNT=number needed to treat; RR=relative reduction; RRR=relative risk reduction.

FINEARTS-HF evaluated ~6000 adult patients with HF LVEF ≥40% taking KERENDIA or placebo​

KERENDIA has a generally well-tolerated safety profile1,24

Adverse reactions reported in ≥1% of patients on KERENDIA and more frequently than placebo1,10,24

Permanent discontinuations due to adverse events were similar between KERENDIA and placebo (3.2% vs 2.8%, respectively)24

Adverse reactions related to worsening renal function were reported more frequently in the KERENDIA group (18%) vs placebo (12%) in FINEARTS-HF. The most frequently reported adverse reactions included renal impairment (7% vs 4%), eGFR decreased (5% vs 4%), acute kidney injury (4% vs 2%), and renal failure (3% vs 2%). The majority of events were reported to be mild to moderate. These events led to dose modifications in 9% receiving KERENDIA vs 4% receiving placebo. Hospitalization due to events related to worsening of renal function for the KERENDIA group was 2.0% vs 1.3% with placebo.1

Initiation of KERENDIA may cause an initial small increase in blood creatinine levels (mean change <0.1 mg/dL) and a small decrease in eGFR (mean change 2 to 3 mL/min) that occurs within the first 4 weeks of starting therapy and then stabilizes. These changes were reversible after treatment discontinuation. Initiation of KERENDIA may also cause a small increase in serum uric acid. This increase appears to attenuate over time.1

eGFR=estimated glomerular filtration rate; HF LVEF=heart failure with left ventricular ejection fraction.

Taking aim at HF LVEF ≥40% from a different angle

KERENDIA addresses critical drivers of disease by targeting the mineralocorticoid receptor pathway1,15,16

The FDA has categorized KERENDIA in its own drug class as a nonsteroidal MRA1

HF LVEF=heart failure with left ventricular ejection fraction; MR=mineralocorticoid receptor; MRA=mineralocorticoid receptor antagonist.