Empagliflozin reduces risk of chronic kidney disease progression
Posted: 7 November 2022 | Catherine Eckford (European Pharmaceutical Review) | No comments yet
A major trial evaluating Boehringer Ingelheim’s Jardiance®, showed it reduced the risk of cardiovascular death and chronic kidney disease progression by 28 percent.
Results from the EMPA-KIDNEY Phase III clinical trial announced at the American Society of Nephrology (ASN)’s Kidney Week 2022, demonstrated Jardiance® (empagliflozin) reduced the risk of kidney disease progression or cardiovascular death by 28 percent versus placebo in adults with chronic kidney disease (CKD).
The trial is the largest sodium-glucose co-transporter-2 (SGLT2) inhibitor study ever conducted for CKD. Researchers assessed kidney and cardiovascular outcomes in 6,609 participants across the CKD severity spectrum.
Data exhibited a 14 percent reduction in hospitalisation for any cause versus placebo:
- Hazard Ratio (HR) of 0.86
- Confidence Interval (CI) of 95 percent, 0.78 to 0.95, p=0.0025
Statistical risk of kidney disease progression or cardiovascular death observed in the study:
- HR of 0.72 and 95 percent (CI), 0.64 to 0.82, p<0.000001
Overall safety data of the trial was consistent with prior data.
The potential of empagliflozin for CKD
“[These] results demonstrate that empagliflozin may benefit adults at risk of progression, including those with or without diabetes and across a wide range of kidney function,” explained William Herrington, Honorary Consultant Nephrologist, co-Principal Investigator of the study and Associate Professor at Medical Research Council Population Health Research Unit (MRC PHRU), part of Oxford Population Health.
Professor Richard Haynes, co-Principal Investigator stated: “Previous SGLT2 inhibitor trials focused on certain groups of people living with chronic kidney disease, such as those with diabetes or high levels of protein in their urine. [The] positive trial results across a broad CKD population reflect an opportunity to improve the treatment of this disease and prevent people from needing dialysis.”
Dr Jeff Emmick, Vice President, Product Development at Lilly shared that plans for worldwide marketing authorisations will go ahead in due course.
Boehringer Ingelheim and Eli Lilly and Company collaborated with the MRC PHRU at the University of Oxford to design, conduct and analyse the research.
The results have been published in The New England Journal of Medicine.