Boehringer Ingelheim (Boehringer) and Eli Lilly’s (Lilly) Jardiance (empagliflozin) demonstrated a significant kidney and cardiovascular benefit for adult patients with chronic kidney disease (CKD) in the phase 3 EMPA-KIDNEY trial, according to new results announced by the two companies.
EMPA-KIDNEY is a multinational, randomised, double-blind, placebo-controlled clinical trial, evaluating the effect of Jardiance on kidney disease progression and cardiovascular mortality risk in 6,609 patients across a wide range of underlying causes.
The study met its primary endpoint, showing that Jardiance reduced the risk of kidney disease progression or cardiovascular death by 28% versus placebo.
A 14% reduction in all-cause hospitalisations versus placebo was also demonstrated, one of the pre-specified key secondary confirmatory endpoints of the study.
Reductions in other key secondary endpoints of hospitalisation for heart failure or cardiovascular death or all-cause death were not statistically significant, the companies reported, and the overall safety data was generally consistent with previous findings.
“Previous SGLT2 inhibitor trials focused on certain groups of people living with CKD, such as those with diabetes or high levels of protein in their urine. Today’s positive trial results across a broad CKD population reflect an opportunity to improve the treatment of this disease and prevent people from needing dialysis,” said Professor Richard Haynes, co-principal investigator of the trial.
CKD, also known as chronic renal disease, is a long-term condition characterised by a gradual loss of kidney function. The condition doubles a person’s risk for hospitalisation and is a leading cause of global deaths, with risk factors including hypertension, diabetes, obesity, primary renal disorders and anaemia.
There remains an unmet need for convenient treatment options with efficacy and safety comparable to current treatments, which include lifestyle changes, drugs to control associated problems, dialysis and, at more advanced stages, kidney transplants.
“We know that there is an urgent need for new therapies proven to delay CKD progression which can lead to the need for dialysis or transplantation. Today’s results demonstrate that Jardiance may benefit adults at risk of progression, including those with or without diabetes, and across a wide range of kidney function,” said William Herrington, associate professor at the Medical Research Council Population Health Research Unit at the University of Oxford – which collaborated with the two companies on the trial – honorary consultant nephrologist, and EMPA-KIDNEY co-principal investigator.