Empagliflozin trials were discontinued after successful CKD results

The EMPA-KIDNEY trial, which evaluates the effects of empagliflozin in adults with chronic kidney disease (CKD), was announced to be discontinued early following recommendations from the study’s independent data monitoring committee. A formal interim evaluation of Boehringer Ingelheim / Eli Lilly and Company’s treatments found that empagliflozin meets pre-specified efficacy criteria.

On behalf of the largest SGLT2 inhibitor study in CKD to date, EMPA-Kidney Is not met because it evaluates the efficacy and safety of empagliflozin in adults with CKD, which is frequently seen in clinical practice but underestimated in previous SGLT2 inhibitor trials. Meet your needs. The trial includes individuals who present the following:

• Mild to severely reduced eGFR (measure of renal function)
• Normal and increased levels of albumin (a type of protein present in urine)
• With or without diabetes
• CKD due to a wide range of root causes.

EMPA-KIDNEY is a large, double-blind, randomized, placebo-controlled, academic-led trial of more than 6,600 adults with CKD.The trial is conducted, analyzed and reported by MRC Population Health Research Unit At Oxford University. The primary endpoint of the study is a combination of renal disease progression * or cardiovascular death. The main side effects include hospitalization for cardiovascular death or heart failure, hospitalization for all causes, and death for all causes.

“Every year, 5 to 10 million people die from chronic kidney disease worldwide, and many lives are severely disrupted by dialysis treatment,” said William Herrington, Associate Professor, Oxford Population Health Clinic, and Honorary Consultant Nephrologist. EMPA-KIDNEY Co-Senior Researcher commented. “We have studied a wide range of patients with impaired renal function with the aim of delaying the need for dialysis and avoiding heart disease in as many patients as possible.”

Expressing joy in the news, co-principal researcher Professor Richard Haynes said: We are very grateful to all the participants who made this exam possible and look forward to sharing detailed exam results later this year. ”

Kidney disease is a global public health problem affecting nearly 850 million people. This is more than 1 in 10 adults. CKD is the leading cause of death in the world and doubles the risk of hospitalization. In addition, CKD is closely associated with several metabolic and cardiovascular diseases such as diabetes, hypertension and obesity. It helps to highlight the widespread benefits of these empagliflozin test results.

“As part of a larger community dedicated to helping millions of people with chronic kidney disease, early termination of EMPA-KIDNEY takes us one step closer to achieving this goal,” Corporate said. Dr. Waheed Jamal, Vice President and Head, explains. Of Cardiac Metabolism Medicine, Boehringer Ingelheim. “EMPA-KIDNEY adds to the success of the EMPOWER trial program, which has already demonstrated the cardiorenal and metabolic benefits of empagliflozin to millions of people worldwide.”

The full results of the EMPA-KIDNEY trial to evaluate empagliflozin will be presented at an upcoming medical conference.

* Defined as end-stage renal disease (start of maintenance dialysis or consultation for kidney transplantation), eGFR is persistently reduced to less than 10 ml / min / 1.73 m²Persistent reduction of at least 40% of eGFR due to renal death or randomization).

† Secondary pre-specified exploratory endpoint: onset or exacerbation of nephropathy, 39% reduction in relative risk.Defined as progression to macroalbuminuria, doubling of serum creatinine (with eGFR) [MDRD] ≤ 45ml / min / 1.73m²), Initiation of renal replacement therapy or death due to renal disease.

eGFR, estimated glomerular filtration rate; MDRD, diet changes in renal disease.