Heart failure and chronic kidney disease often go hand in hand. And when they do, the risk of death and hospitalization increase.
A new analysis from Eli Lilly and Boehringer Ingelheim on their partnered drug Jardiance show that it can reduce the risk of death and hospitalization from heart failure while also slowing the decline of kidney function. The analysis comes from the partners' phase 3 Emperor-Preserved trial in heart failure patients.
This could be a breakthrough for a large population as nearly half of the 6 million people in the U.S. who have heart failure also suffer from chronic kidney disease. There are no approved treatments that have been proven to significantly improve outcomes across the full spectrum of heart failure, the partners pointed out.
“Heart failure and chronic kidney disease are intimately linked—the risk of death in people with heart failure increases with kidney function decline,” Faiez Zannad, M.D., the clinical investigator of the trial said in a statement. “The consistent benefits shown for the reduction of serious heart failure events and the slowing of kidney function decline regardless of chronic kidney disease status are welcome results for patients and physicians.”
In the study, 53.5% of patients had kidney disease and 9.7% had severe kidney impairment. While Jardiance reduced the risk of cardiovascular death or hospitalization from heart failure, compared with placebo, it also slowed kidney function decline in adults with heart failure with left ventricular ejection fraction over 40% regardless of chronic kidney disease status at baseline.
Next year, Lilly and Boehringer Ingelheim will read out results from the Empa-Kidney phase 3 trial further exploring the effectiveness of Jardiance on patients with kidney disease.
“This data marks an important milestone for the growing number of people living with both heart failure and chronic kidney disease, many of whom need additional treatment options for these interconnected, complex conditions,” Jeff Emmick, M.D., Lilly’s VP of product development said in a statement.
Jardiance, a SGLT2 inhibitor, was originally approved for the treatment of type 2 diabetes in 2014. Two years later, it was green-lighted to reduce the risk of cardiovascular death in those with diabetes.
In August, the FDA endorsed Jardiance for those with heart failure with reduced ejection fraction (HFrEF). Later in the month, Lilly and Boehringer presented data that showed Jardiance’s effectiveness against those with heart failure with preserved ejection fraction (HFpEF), with or without diabetes.
A HFpEF nod would make Jardiance the only med to improve outcomes in all heart failure patients. It would also distinguish the drug from other heart failure treatments such as AstraZaneca’s Farziga, Novartis’ Entresto and Merck and Bayer’s Verquvo.
In April of this year, Farziga scored approval for chronic kidney disease in patients at risk of progression. Farziga was endorsed by the FDA for HFrEF in May of 2020.