In the FIGARO-DKD and FIDELIO-DKD exploratory analyses of adult patients with CKD associated with T2D
*Remained stable for the duration of the trials.13
In FIDELIO-DKD, SBP was measured as part of the laboratory parameter safety evaluation6
Addition and modification of background antihypertensive treatment throughout the trial was permitted at the discretion of the investigators in line with local guideline recommendations if blood pressure was thought to be uncontrolled at any point during the trial.6
KERENDIA has not been studied for and is not indicated for the treatment of hypertension.13
*Mixed model exploratory analysis with covariate factors of treatment group, eGFR category, albuminuria type, treatment time and baseline value, and baseline value time.6
CKD=chronic kidney disease; CV=cardiovascular; eGFR=estimated glomerular filtration rate; LS=least-squares; SBP=systolic blood pressure; T2D=type 2 diabetes; UACR=urine albumin-to-creatinine ratio.
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)
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
Please read the Prescribing Information for KERENDIA.