Jardiance® displays 21 percent risk reduction in heart failure patients
Jardiance displayed a 21 percent risk reduction in adults with heart failure with preserved ejection fraction in Phase III study.
Boehringer Ingelheim and Eli and Lilly have announced that Jardiance® (empagliflozin) showed a 21 percent relative risk reduction for the composite primary endpoint of cardiovascular death or hospitalisation for heart failure in adults with heart failure with preserved ejection fraction (HFpEF), compared with placebo, in their EMPEROR-Preserved Phase III study.
The benefit was independent of ejection fraction or diabetes status, which the companies said establishes Jardiance as the first and only treatment to significantly improve outcomes for the full spectrum of heart failure patients.
The EMPEROR heart failure studies are two Phase III, randomised, double-blind trials investigating once-daily Jardiance compared with placebo in adults with heart failure with preserved or reduced ejection fraction, both with and without diabetes, who are receiving current standard of care.
EMPEROR-Preserved included 5,988 people with HFpEF. Of these, 4,005 had a left ventricular ejection fraction (LVEF) of 50 percent or above and 1,983 had a LVEF below 50 percent. Trial participants were randomly assigned to Jardiance 10mg or placebo once daily. The overall safety data was consistent with previous findings, confirming the well-established safety profile of Jardiance.
Further to meeting its composite primary endpoint, key secondary endpoint analyses from the trial showed that Jardiance also reduced the relative risk of first and recurrent hospitalisations for HFpEF by 27 percent and significantly slowed kidney function decline.
“In the first successful trial in this difficult-to-treat form of heart failure, Jardiance demonstrated a statistically significant improvement in outcomes for adults with heart failure across the spectrum of left ventricular ejection fraction in the trial,” commented Mohamed Eid at Boehringer Ingelheim Pharmaceuticals. “This is the kind of news that has the potential to change treatment paradigms, and it is thrilling to see this level of benefit in both hospitalisations and kidney function.”
The US Food and Drug Administration (FDA) have already approved Jardiance to reduce the risk of cardiovascular death plus hospitalisation for heart failure in adults with HFrEF. Jardiance was the first type 2 diabetes treatment approved to reduce the risk of cardiovascular death in adults with type 2 diabetes and known cardiovascular disease.
The Boehringer Ingelheim-Lilly Alliance stated that they plan for global regulatory submissions in HFpEF in 2021. Research is ongoing regarding the effects of Jardiance on hospitalisation for heart failure and mortality in post-myocardial infarction (heart attack) patients with high risk of heart failure. Jardiance is also currently being investigated in chronic kidney disease.
The results from the trial were presented at the European Society of Cardiology (ESC) Congress 2021 and published in NEJM.