In the FIGARO-DKD trial of adult patients with CKD associated with T2D
KERENDIA: Proven to reduce the risk of CV events13*†
2.1% ARR16 (95% CI: 0.4-3.8)
NNT: 4716 (95% CI: 26-266)
to prevent a primary composite endpoint event
at 42 months
The FIGARO-DKD trial included majority earlier-stage (1-2) CKD patients (defined as eGFR ≥60 mL/min/1.73 m2 with albuminuria).3,10,13
Primary composite endpoint consisted of CV death, non-fatal MI, non-fatal stroke, or hospitalization for HF.13
The treatment effect was mainly driven by an effect on hospitalization for HF, though CV death also contributed.13
Individual components of the composite endpoint were exploratory in nature and not adjusted for multiplicity.3
KERENDIA is not indicated to reduce the risk of non-fatal stroke.13
CV OUTCOMES FROM FIDELIO-DKD13‡
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.
Provide dual cardiorenal risk reduction with KERENDIA13
In the FIDELIO-DKD trial of adult patients with CKD associated with T2D
KERENDIA: Proven to slow CKD progression13*†
3.4% ARR4 (95% CI: 0.6-6.2)
NNT: 294 (95% CI: 16-166)
to prevent a primary composite endpoint event
at 36 months
The FIDELIO-DKD trial included majority later-stage (3-4) CKD patients (defined as eGFR <60 mL/min/1.73 m2 with albuminuria).3,10,13
Primary composite endpoint consisted of kidney failure,‡ sustained eGFR decline of ≥40%, or renal death.13
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.13
RENAL OUTCOMES FROM FIGARO-DKD16§
The key secondary composite outcome of kidney failure, sustained eGFR decline of ≥40%, or renal death, which 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.
Provide dual cardiorenal risk reduction with KERENDIA13
*FIGARO-DKD (N=7352) was a randomized, double-blind, placebo-controlled, multicenter trial with median follow-up period of 3.4 years.13
†All patients received the maximum tolerated doses of an ACEi or ARB.13
‡FIDELIO-DKD (N=5674) was a randomized, double-blind, placebo-controlled, multicenter trial with a median follow-up period of 2.6 years.13
ACEi=angiotensin-converting enzyme inhibitor; ARB=angiotensin receptor blocker; ARR=absolute risk reduction; CKD=chronic kidney disease; CV=cardiovascular; eGFR=estimated glomerular filtration rate; HF=heart failure; HR=hazard ratio; MI=myocardial infarction; NEJM=New England Journal of Medicine; NNT=number needed to treat; RRR=relative risk reduction; T2D=type 2 diabetes.
*FIDELIO-DKD (N=5674) was a randomized, double-blind, placebo-controlled, multicenter trial with a median follow-up period of 2.6 years.13
†All patients received the maximum tolerated doses of an ACEi or ARB.13
‡Kidney failure was defined as chronic dialysis, kidney transplantation, or a sustained decrease in eGFR to <15 mL/min/1.73 m2.13
§FIGARO-DKD (N=7352) was a randomized, double-blind, placebo-controlled, multicenter trial with median follow-up period of 3.4 years.13
ACEi=angiotensin-converting enzyme inhibitor; ARB=angiotensin receptor blocker; ARR=absolute risk reduction; CKD=chronic kidney disease; CV=cardiovascular; eGFR=estimated glomerular filtration rate; HR=hazard ratio; NEJM=New England Journal of Medicine; NNT=number needed to treat; RRR=relative risk reduction; T2D=type 2 diabetes.
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.
