Jardiance Approved for Adults With Chronic Kidney Disease

The Food and Drug Administration (FDA) has approved Jardiance^® (empagliflozin) to reduce the risk of sustained decline in estimated glomerular filtration rate (eGFR), end-stage kidney disease, cardiovascular death and hospitalization in adults with chronic kidney disease (CKD) at risk of progression. 

The approval was based on data from the phase 3 EMPA-KIDNEY trial (ClinicalTrials.gov Identifier: NCT03594110), which included 6609 adults with CKD (eGFR ≥20 to <45mL/min/1.73 m²; or eGFR ≥45 to <90mL/min/1.73 m² with urine albumin to creatinine ratio [UACR] ≥200mg/g). Approximately 44% of the study population had type 2 diabetes. 

Patients were randomly assigned to receive empagliflozin 10mg or placebo once daily, in addition to standard of care. The primary composite endpoint was the time to first occurrence of kidney disease progression (defined as end stage kidney disease with a sustained decline in eGFR <10mL/min/1.73m², renal death, or a sustained decline of ≥40% in eGFR) or CV death.

Findings showed that treatment with empagliflozin met the primary endpoint reducing the risk of kidney disease progression or CV death by 28% compared with placebo (hazard ratio [HR], 0.72; 95% CI, 0.64-0.82; P <.0001); results were generally consistent across prespecified subgroups, including eGFR categories, underlying cause of kidney disease, diabetes status, and background use of renin-angiotensin system inhibitors. Empagliflozin was also associated with a 14% reduction in the risk of first and recurrent hospitalization compared with placebo (HR, 0.86; 95% CI, 0.78-0.95; P =.0025).

“This approval provides health care professionals in the US with another treatment option for adults with CKD that can reduce the risk of kidney function decline, kidney failure, cardiovascular death and hospitalizations,” said Katherine Tuttle, MD, Executive Director for Research, Providence Inland Northwest Health, Regional Principal investigator for the Institute of Translational Health Sciences and Professor of Medicine at the University of Washington, and EMPA-KIDNEY steering committee member. “The meaningful benefits that empagliflozin demonstrated in the EMPA-KIDNEY phase 3 trial are welcome news for adults living with CKD in this country.”

Jardiance is not recommended for the treatment of CKD in patients with polycystic kidney disease or patients requiring or with a recent history of intravenous immunosuppressive therapy or greater than 45mg of prednisone or equivalent for kidney disease. It is not expected to be effective in these populations.

This article originally appeared on MPR