Indications
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CKD Associated With T2D
HF LVEF ≥40%

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

In a prespecified exploratory subgroup analysis

KERENDIA showed a consistent treatment effect for the primary endpoint across all subgroups, including SGLT2i use1,26

Primary endpoint
Subgroup analysis

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 receiving KERENDIA vs placebo (RR=0.82 [95% CI: 0.71-0.94]; P=0.006)1

KERENDIA for CKD in 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]).10

ARR=absolute risk reduction; CI=confidence interval; CKD=chronic kidney disease; 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; T2D=type 2 diabetes.

Treatment effect with or without baseline SGLT2i use26
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.10

ARR=absolute risk reduction; CI=confidence interval; CV=cardiovascular; HF=heart failure; PY=patient year; RR=relative reduction; SGLT2i=sodium-glucose cotransporter 2 inhibitor.

Trial Design Efficacy Safety
  • Total HF events: 18% RRR vs placebo (RR=0.92 [95% CI: 0.71-0.94]; P=0.006)1
  • CV death: 7% RRR vs placebo (RR=0.93 [95% CI: 0.78-1.11])1

CI=confidence interval; CV=cardiovascular; HF=heart failure; RR=relative reduction; RRR=relative risk reduction.

KERENDIA for CKD associated with T2D:
efficacy and safety overview

Trial designs: FIGARO-DKD (N=7352) and FIDELIO-DKD (N=5674) were randomized, double-blind, placebo-controlled, multicenter, phase 3 trials with median follow-up periods of 3.4 and 2.6 years, respectively. Standard of care background therapy in both trials was maximum tolerated labeled dose ACEi or ARB.1

FIGARO-DKD1,25

13%RRR

Primary CV composite endpoint1,25

On top of standard of care, 13% RRR vs placebo, HR=0.87 (95% CI: 0.76-0.98), P=0.026

32%placebo-
corrected RR

Exploratory analysis1

UACR reduction relative to placebo on top of standard of care: 32%
(95% CI: 30-35%), at month 4

Secondary renal composite endpoint1,25

The key secondary composite of kidney failure, sustained eGFR decline of ≥40%, or renal death occurred in 350 patients in the KERENDIA group (9.5%) and 395 patients in the placebo group (10.8%) (HR=0.87 [95% Cl: 0.76-1.01]). The difference was not statistically significant

FIDELIO-DKD1

18%RRR

Primary renal composite endpoint1

On top of standard of care, 18% RRR vs placebo, HR=0.82 (95% CI: 0.73-0.93), P=0.001

31%placebo-
corrected RR

Exploratory analysis1

UACR reduction relative to placebo on top of standard of care: 31%
(95% CI: 29-34%), at month 4

14%RRR

Secondary CV composite endpoint1

On top of standard of care, 14% RRR vs placebo, HR=0.86 (95% CI: 0.75-0.99), P=0.034

Safety: pooled data FIGARO-DKD and FIDELIO-DKD1

Adverse reactions reported in ≥1% of patients taking KERENDIA and more common than placebo

Hyperkalemia:
14% (KERENDIA: n=912/6510)
vs 6.9% (placebo: n=448/6489)

Hypotension:
4.6% (KERENDIA: n=302/6510)
vs 3.0% (placebo: n=194/6489)

Hyponatremia:
1.3% (KERENDIA: n=82/6510)
vs 0.7% (placebo: n=47/6489)

ACEi=angiotensin-converting enzyme inhibitor; ARB=angiotensin receptor blocker; 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.

KERENDIA showed a consistent treatment effect for the primary endpoint across all prespecified subgroups10

Select prespecified exploratory subgroups

All prespecified exploratory subgroups were underpowered. Results should be interpreted with caution.10

From The New England Journal of Medicine, Solomon SD, McMurray JJV, Vaduganathan M, et al. Finerenone in heart failure with mildly reduced or preserved ejection fraction, 391(16), 1475-1485. Copyright © 2024 Massachusetts Medical Society. Reprinted with permission from Massachusetts Medical Society.10

CI=confidence interval; eGFR=estimated glomerular filtration rate; HF=heart failure; LVEF=left ventricular ejection fraction; NYHA=New York Heart Association.