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November 8, 2021

Lilly-Boehringer’s oral drug shows cardio-renal benefits in Phase III trial

Empagliflozin showed benefits in adults with heart failure with LVEF by over 40%, irrespective of chronic kidney disease status.

Boehringer Ingelheim and Eli Lilly have reported that their oral drug, empagliflozin, decreased the risk of cardiovascular death or heart failure-associated hospitalisation and slowed the decline in kidney function in the Phase III EMPEROR-Preserved clinical trial.

The findings observed that risks were reduced in adult subjects suffering from heart failure with left ventricular ejection fraction (LVEF) by more than 40%, irrespective of their chronic kidney disease status at baseline.

Sold as Jardiance, empagliflozin is an inhibitor of sodium-glucose cotransporter 2 (SGLT2).

The randomised, double-blind Phase III trial analysed once-daily dose regimen of empagliflozin against placebo in adult patients with chronic heart failure with reduced ejection fraction (HFrEF) or heart failure with preserved ejection fraction (HFpEF) independent of their status on diabetes.

The primary goal of the trial is the time to the first occurrence of adjudicated cardiovascular death or hospitalisation due to heart failure.

According to the data from the latest prespecified sub-analysis, empagliflozin’s benefits in the overall population were in line with adult subjects with and without chronic kidney disease.

Besides improving cardiovascular outcomes, empagliflozin helped to slow the decline in kidney function to an eGFR of 20mL/min/1.73m.

The drug was found to be well tolerated in the trial, irrespective of the baseline kidney function level.

In addition, empagliflozin substantially reduced the incidence of first and recurrent heart failure-associated hospitalisations and delayed kidney function decline.

Lilly Product Development vice-president Jeff Emmick said: “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.

“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 empagliflozin, from which we eagerly await a readout next year.”

In August this year, the companies reported positive results from the Phase III EMPEROR-Preserved trial.

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