Date: 2015-09-17
Type of information: Publication of results in a medical journal
phase: 3
Announcement: publication of results in The New English Journal of Medicine
Company: Boehringer Ingelheim (Germany) Eli Lilly (USA - IN)
Product: Jardiance® (empagliflozin)
Action
mechanism: SGLT2 inhibitor. Empagliflozin inhibits SGLT-2 (sodium-dependent glucose co-transporter-2), which blocks glucose reuptake in the kidney, thereby removing excess glucose through the urine. The product has been developed by Boehringer Ingelheim and Eli Lilly. In January 2011, the two companies have announced an alliance in the field of diabetes that centers on four pipeline compounds including empaglifozin.
Disease: type 2 diabetes
Therapeutic area: Cardiovascular diseases - Metabolic diseases
Country: Argentina, Australia, Austria, Belgium, Brazil, Canada, Colombia, Croatia, Czech Republic, Denmark, Estonia, France, Georgia, Greece, Hong Kong, Hungary, India, Indonesia, Israel, Italy, Japan, Republic of Korea, Malaysia, Mexico, Netherlands, New Zealand, Norway, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Singapore, South Africa, Spain, Sri Lanka, Taiwan, Thailand, Ukraine, UK, USA
Trial
details: EMPA-REG OUTCOME was a multicenter, randomized, double-blind, placebo-controlled trial that involved more than 7,000 individuals from 42 countries observed for a median duration of 3.1 years. The study was designed to assess the effect of Jardiance® (10mg or 25mg once daily) added to standard of care compared with placebo added to standard of care on CV events in adults with type 2 diabetes at high risk of cardiovascular events and with less than optimized blood glucose control. The study was designed to first test for non-inferiority and then for superiority. Standard of care was comprised of glucose lowering agents and cardiovascular drugs (including antihypertensive and lipid lowering agents). (NCT01131676)
Latest
news: * On September 17, 2015, Eli Lilly and Boehringer Ingelheim announced that results of the EMPA-REG OUTCOME® trial were published in The New England Journal of Medicine and also presented at the 51st European Association for the Study of Diabetes Annual Meeting. These results show that Jardiance® (empagliflozin) significantly reduced the risk of the combined endpoint of cardiovascular death, non-fatal heart attack or non-fatal stroke by 14 percent when added to standard of care in patients with type 2 diabetes at high risk of cardiovascular events. There was a 38 percent reduction in cardiovascular death, with no significant difference in the risk of non-fatal heart attack or non-fatal stroke. In addition, treatment with Jardiance® resulted in a lower risk of all-cause mortality (32 percent reduction) and hospitalization for heart failure (35 percent reduction) (2015, September 17, 2015DOI: 10.1056/NEJMoa1504720). Life expectancy of people with type 2 diabetes at high cardiovascular risk is, on average, decreased by up to 12 years with approximately 50 percent of deaths in people with type 2 diabetes caused by cardiovascular disease. The effect of Jardiance® in this trial was observed on top of standard of care. This means the benefit was seen over and above other treatments patients were already receiving for diabetes and/or cardiovascular disease (such as blood pressure and cholesterol lowering-medications). The overall safety profile of Jardiance® was consistent with previous trials. The incidence of diabetic ketoacidosis was at or below 0.1 percent and similar across all treatment groups. EMPA-REG OUTCOME was a long-term, multicenter, randomized, double-blind, placebo-controlled trial that involved more than 7,000 patients from 42 countries with type 2 diabetes at high risk for cardiovascular events. There were 772 primary outcome events in the EMPA-REG OUTCOME trial over a median observation period of 3.1 years. Of the 7,020 treated patients, more than 97 percent completed the trial and vital status was available for more than 99 percent of these patients at study end. Analyses and results were independently validated and confirmed by the University of Freiburg, Germany, an internationally renowned academic center specializing in statistical analyses. * On August 20, 2015, Boehringer Ingelheim and Eli Lilly announced positive top-line results from EMPA-REG OUTCOME®. This is a long-term clinical trial investigating cardiovascular outcomes for Jardiance® (empagliflozin) in more than 7,000 adults with type 2 diabetes at high risk for cardiovascular events. EMPA-REG OUTCOME met its primary endpoint and demonstrated superiority of Jardiance®, when added to standard of care, in cardiovascular risk reduction. The primary endpoint was defined as time to first occurrence of either cardiovascular death, or non-fatal myocardial infarction or non-fatal stroke. Jardiance® is the only glucose-lowering agent to have demonstrated cardiovascular risk reduction in a dedicated cardiovascular outcomes trial. The safety profile of Jardiance® was consistent with previous studies. Detailed study results will be presented on September 17 at the 51st European Association for the Study of Diabetes Annual Meeting in Stockholm, Sweden.
