Data from Pharmawand - Curated by EPG Health - Date added 12 June 2019

A new post-hoc analysis of data from the EMPA-REG OUTCOME trial indicates a consistent effect of Jardiance (empagliflozin) on reducing cardiovascular and renal risk in adults with type 2 diabetes and known cardiovascular disease who also have a form of chronic kidney disease without overt proteinuria (high levels of protein in the urine), as well as others in the trial. The results were shared as an oral presentation on behalf of Boehringer Ingelheim and Eli Lilly and Company at the American Diabetes Association (ADA)'s 79th Scientific Sessions on June 10 in San Francisco.

In this new post-hoc analysis, the effect of Jardiance on reducing risk for cardiovascular and kidney outcomes was consistent between people in the EMPA-REG OUTCOME trial who had chronic kidney disease without overt proteinuria and all others in the trial. Outcomes examined included cardiovascular death, hospitalization for heart failure, new or worsening kidney disease, and the combination of cardiovascular death or hospitalization for heart failure, as well as safety outcomes of interest.

Furthermore, results from a separate post-hoc analysis recently presented at the ISN World Congress of Nephrology 2019, indicated that the effect of empagliflozin on the cardiorenal outcome was consistent between people in the EMPA-REG OUTCOME trial who had proteinuric kidney disease and all others in the trial. Together, these post-hoc analyses suggest that the effect of empagliflozin on cardiorenal outcomes is consistent regardless of whether patients have proteinuric kidney disease or not.

EMPA-KIDNEY (NCT03594110) will enroll approximately 5,000 adults with chronic kidney disease both with and without diabetes as well as with and without proteinuria. The trial is an academic collaboration that will be independently conducted, analyzed and reported by the Medical Research Council Population Health Research Unit at the University of Oxford (MRC PHRU), which is based in the Clinical Trial Service Unit and Epidemiological Studies Unit (CTSU). Boehringer Ingelheim and Lilly will provide the funding for the study as part of their commitment to advancing treatments and pioneering research to address the public health challenges of cardiovascular, metabolic and kidney diseases beyond type 2 diabetes.


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