Boehringer Ingelheim and Eli Lilly have reported data from the Phase III EMPACT-MI clinical trial of Jardiance (empagliflozin) on the risk of heart failure hospital admission and mortality following a heart attack.
The randomised, multicentre, parallel-group, double-blind, placebo-controlled superiority trial investigated Jardiance on all-cause mortality and hospitalisation in such patients.
It included more than 6,500 adult patients from 22 countries who were randomised to receive either Jardiance 10mg or a placebo daily, in addition to standard of care.
Participants, who had no history of chronic heart failure, were eligible regardless of their type 2 diabetes and chronic kidney disease status.
The composite measure of time to first hospital admission due to heart failure or all-cause mortality up to 26 months was the trial’s primary endpoint.
The EMPACT-MI trial results were reported in partnership with the Duke Clinical Research Institute (DCRI) and it was funded by Boehringer Ingelheim and Lilly.
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By GlobalDataData revealed a 10% relative decline in risk on the primary composite endpoint for participants treated with Jardiance compared to placebo, which did not reach statistical significance.
Further exploratory analyses indicated a relative decline in risk of 23% for time to first hospital admission due to heart failure and 33% for total hospitalisations due to heart failure with Jardiance compared to placebo.
Boehringer Ingelheim Pharmaceuticals Cardio-Renal-Metabolic Medicine Clinical Development & Medical Affairs vice-president Mohamed Eid said: “These results add to our understanding of SGLT2 inhibitors and contribute to the body of evidence across six clinical studies examining the potential for Jardiance to impact major outcomes in a broad population of adults with heart failure, chronic kidney disease or type 2 diabetes.
“Building on this strong foundation, we remain committed to leading efforts aimed at increasing awareness, generating real-world evidence and advancing care for people affected by interconnected cardiovascular, renal and metabolic diseases.”
In November 2021, the companies reported that 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 trial.