More positive CV data for Boehringer and Lilly’s Jardiance
pharmafile | September 21, 2015 | News story | Research and Development, Sales and Marketing | Boehringer Ingelheim, EASD, Eli Lilly, cardiovascular risk, empagliflozin, jardiance, mortality risk, type 2 diabetes
Jardiance, an anti-diabetes drug produced by Boehringer Ingelheim and Eli Lilly, reduces the risk of death in people with type 2 diabetes, according to the results of a Phase III study.
The results of the EMPA-REG OUTCOME trial found Jardiance (empagliflozin) had a statistically significantly 14% lower rate of the primary outcome – death from cardiovascular causes – when the study drug was added to standard care, compared to treatment with standard care alone.
There was a 38% reduction in the relative risk of death from cardiovascular causes, but no significant difference in the risk of non-fatal heart attack or non-fatal stroke. There was also a 32% reduction in the relative risk of death from any cause, and a 35% reduction in the risk of hospitalisation for heart failure, compared to standard care.
Patients who took Jardiance had a higher rate of genital infection, which was reported in 0.4% of patients in the Jardiance group and 0.1% of those in the placebo group. There was no increase in other adverse events.
The presentation, by co-author Dr Bernard Zinman from the Lunenfeld-Tanenbaum Research Institute in Toronto, was met with applause from delegates at the European Association for the Study of Diabetes annual meeting in Stockholm.
He told delegates: “These results are both novel and exciting for the millions of people living with type 2 diabetes at risk for cardiovascular disease. Addressing the burden of cardiovascular events, including death, is at the core of diabetes care, and until now no single diabetes medication has been associated with a reduction in mortality. In this study, empagliflozin was shown to prevent one out of three cardiovascular deaths.”
“The Boehringer Ingelheim and Lilly Diabetes Alliance is very pleased to share the results of the EMPA- REG OUTCOME trial with the healthcare community,” said Professor Hans-Juergen Woerle, global vice president of medicine at Boehringer Ingelheim. “Cardiovascular disease is the number one cause of death in people with type 2 diabetes worldwide and reducing cardiovascular risk, including death, is an essential component of diabetes management.”
The alliance announced in August that the trial had met its primary endpoint, making Jardiance the only diabetes drug to show a significant reduction in both cardiovascular risk and cardiovascular death in a dedicated outcome trial.
“There are very few therapies we have in cardiovascular medicine that have ever shown a one-third reduction in the risk of cardiovascular death,” said Dr Steven Nissen, chairman of cardiovascular medicine at the Cleveland Clinic, who was not involved in the study.
Lilian Anekwe
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