Jardiance Slows Kidney Decline by 40% in Heart Failure Patients
In the Phase 3 trial, Eli Lilly’s Jardiance was well tolerated, consistently improved cardiovascular outcomes, and reduced the risk of death or hospitalization across all heart failure patients.
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By - Eli Lilly and Company recently announced that Jardiance slowed kidney function decline in adults with heart failure with left ventricular ejection fraction (LVEF) over 40 percent regardless of chronic kidney disease status at baseline.
The EMPEROR-Preserved Phase 3 trial enrolled 5,988 adults with and without type 2 diabetes. Participants were randomized to receive once-daily Jardiance 10 milligrams or placebo, on top of treatment with guideline-directed heart failure therapy.
About 53.5 percent of adults in the trial had chronic kidney disease, and 9.7 percent had severe kidney impairment.
Overall, Jardiance was well tolerated, consistently improved cardiovascular outcomes, and reduced the risk of death or hospitalization across all participants.
“This data marks an important milestone for the growing number of people living with both heart failure and chronic kidney disease, many of whom are in need of additional treatment options for these interconnected, complex conditions,” Jeff Emmick, MD, PhD, vice president of product development at Eli Lilly and Company, said in the announcement.
“We look forward to continuing research with the goal of addressing the unmet needs of those with kidney impairment, including through our EMPA-KIDNEY phase III trial of Jardiance, from which we eagerly await a readout next year,” Emmick continued.
In March 2020, FDA granted fast track designation to Jardiance to treat chronic kidney disease.
And at the end of September 2021, FDA granted breakthrough designation to Jardiance to treat adults with heart failure with preserved ejection fraction.
The agency based its decision on results from the EMPEROR-Preserved Phase 3 trial, which found that Jardiance elicited a 21 percent relative risk reduction for the composite primary endpoint of cardiovascular death or hospitalization for heart failure compared to placebo.
The drug also reduced the relative risk of first and recurrent hospitalizations for heart failure by 27 percent and substantially slowed kidney function decline.
Heart failure, especially with preserved ejection fraction, is difficult to treat. And a patient’s condition can worsen with the combination of chronic kidney disease.
“The encouraging results from this sub-analysis further demonstrate the potential for Jardiance to offer a treatment option for adults with cardio-renal-metabolic conditions,” said Mohamed Eid, MD, MPH, MHA, vice president of clinical development & medical affairs, cardio-metabolism & respiratory medicine at Boehringer Ingelheim.
