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Jardiance reduces cardiovascular risk in type 2

By Editor
14th June 2016
Good practice, Latest news Pharmaceutical

New ® (empagliflozin) data shows that reduced risk for cardiovascular (CV) was consistent across age groups in adults with type 2 diabetes.

The findings, which were presented at the American Diabetes Association (ADA) 76th Scientific Sessions in New Orleans, showed the effectiveness of Jardiance®.

It was studied in the Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) EMPA-REG OUTCOME® trial.

Lead investigator of the trial Dr Bernard Zinman, director of the Diabetes Centre at the Mount Sinai Hospital and senior scientist from the Lunenfeld Tanenbaum Research Institute, said: “As people with type 2 diabetes age, their risk for cardiovascular events increases.

“These sub-analyses suggest that empagliflozin is associated with reducing cardiovascular events regardless of age when starting treatment. These data provide additional information about the EMPA-REG OUTCOME trial.”

Consistent reduction

Data presented at the ADA Scientific Sessions examined the effect of treatment with JARDIANCE by age in the EMPA-REG OUTCOME trial.

Trial participants were grouped based on their age at baseline: under 65 years, from 65 to 74, and 75 years and older.

Consistent reduction in the risk of CV death was seen independent of age groups.

Further analysis demonstrated similar consistency by age group in reducing risk for hospitalisation for heart failure, as well as for the combination of hospitalisation for heart failure or CV death.

Adverse events were consistent with the known safety profile of JARDIANCE.

Furthermore, the reduction in risk for CV events did not differ among sub-groups of adults in the EMPA-REG OUTCOME trial based on their LDL (“bad”) cholesterol levels at baseline ( < 70 mg/dL; 70- < 85 mg/dL; 85- < 100 mg/dL; 100-115 mg/dL; and > 115 mg/dL).

The risk reduction with JARDIANCE was consistent across the LDL sub-groups (indicated by a lack of statistical interaction by sub-group) for the combination of CV death, non-fatal heart attack or non-fatal stroke, as well as for the individual outcomes of CV death, hospitalisation for heart failure and death from any cause.

Professor Hans-Juergen Woerle, global vice president medicine for Boehringer Ingelheim, said: “These analyses from the landmark EMPA-REG OUTCOME trial further demonstrate that JARDIANCE reduced the risk of cardiovascular death and hospitalization for heart failure in adults with type 2 diabetes.

“Through our ongoing research, the BI-Lilly Diabetes alliance is proud to continue to advance the understanding of how to improve the management of cardiovascular risk in this population.”

Additional insight into the EMPA-REG OUTCOME findings will be presented at an ADA Scientific Sessions symposium on Tuesday, June 14 at 8:00 a.m. CT.

The trial was a long-term, multicenter, randomised, double-blind, placebo-controlled trial of more than 7,000 patients from 42 countries with type 2 diabetes and established cardiovascular (CV) disease.

The study assessed the effect of JARDIANCE (10 mg or 25 mg once daily) added to standard of care compared with placebo added to standard of care. Standard of care was comprised of glucose-lowering agents and CV drugs (including for blood pressure and cholesterol).

The primary endpoint was defined as time to first occurrence of CV death, non-fatal heart attack or non-fatal stroke.

Over a median of 3.1 years, JARDIANCE significantly reduced the risk of CV death, non-fatal heart attack or non-fatal stroke by 14 percent versus placebo. Risk of CV death was reduced by 38 percent, with no significant difference in the risk of non-fatal heart attack or non-fatal stroke.

The overall safety profile of JARDIANCE in the EMPA-REG OUTCOME trial was consistent with that of previous trials.

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