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Jardiance to be investigated in chronic heart failure trials
19 April 2016 • Author: Victoria White, Digital Content Producer
The companies plan to begin the trials within the next 12 months and are planned to enrol people with chronic heart failure both with and without type 2 diabetes (T2D).
Jardiance was the first diabetes treatment to demonstrate a reduction in the risk of cardiovascular (CV) death in a dedicated CV outcomes trial. EMPA-REG OUTCOME was a long-term, multicenter, randomised, double-blind, placebo-controlled trial of more than 7,000 patients, from 42 countries, with type 2 diabetes at high risk for CV events.
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.
Results of the EMPA-REG OUTCOME trial led to the planned trials
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 was consistent with that of previous trials. These results led to the planned trials.
“The EMPA-REG OUTCOME trial demonstrated that Jardiance reduces the risk of cardiovascular death in diabetes patients at high CV risk, and we now look forward to exploring whether Jardiance can also provide heart failure benefits,” said Professor Hans-Juergen Woerle, global vice president medicine, Boehringer Ingelheim.
“One in two people with heart failure die within five years of diagnosis, so there is currently a compelling need for an effective therapy to treat those suffering from this condition,” said Javed Butler, M.D., cardiologist, Stony Brook University Hospital.
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