Survival estimates from the EMPA-REG OUTCOME trial data demonstrate potential long-term benefit of Jardiance (empagliflozin) on life expectancy of adults with type 2 diabetes and cardiovascular disease
RIDGEFIELD, Conn. and INDIANAPOLIS, Oct. 10, 2018 — Novel results based on data from the landmark EMPA-REG OUTCOME trial were published in the journal Circulation which suggest that treatment with Jardiance® positively impacts life expectancy in adults with type 2 diabetes and established cardiovascular disease, Boehringer Ingelheim and Eli Lilly and Company announced today. Using actuarial methods*, and assuming that the demonstrated beneficial effects of Jardiance remain consistent with long-term use, Jardiance was estimated to extend life expectancy by 1 to 4.5 years on average, depending on age, when compared with placebo. This analysis suggests that treatment with Jardiance could add years of life.
In an analysis of data from 7,020 people included in the EMPA-REG OUTCOME trial, estimated life expectancy increased across all ages when adults were treated with Jardiance as compared to those treated with placebo. Specifically, estimated mean survival in people aged 45 years was 32.1 years with Jardiance versus 27.6 years with placebo, resulting in a mean survival difference of 4.5 years. In people aged 50, 60, 70 and 80 years old, the mean survival difference with Jardiance compared to placebo was an additional 3.1 years, 2.5 years, 2 years and 1 year, respectively.
"For a 60-year-old living with type 2 diabetes, who has already had a cardiovascular event, previous studies estimate that life expectancy could be reduced by up to 12 years compared with someone of the same age without these conditions," commented Brian Claggett, Ph.D., Division of Cardiovascular Medicine, Brigham and Women's Hospital and lead author of the Circulation paper. "This latest analysis estimates that empagliflozin could prolong such a person's life span by, on average, 2.5 years."
The primary EMPA-REG OUTCOME trial results, published in the New England Journal of Medicine in September 2015, demonstrated a 38 percent relative risk reduction in cardiovascular death and a 32 percent relative risk reduction in all-cause mortality with Jardiance in people with type 2 diabetes and established cardiovascular disease, compared with placebo, over a period of 3.1 years. Modelling based on the EMPA-REG OUTCOME trial data was used to quantify the potential benefit of Jardiance on residual life span.
About the EMPA-REG OUTCOME trial (NCT01131676)
The EMPA-REG OUTCOME trial was a long-term, multicenter, randomized, double-blind, placebo-controlled trial of more than 7,000 patients from 42 countries with type 2 diabetes at high risk for cardiovascular events.
The trial 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 cardiovascular drugs (including for blood pressure and cholesterol). The primary endpoint was defined as time to first occurrence of cardiovascular death, non-fatal heart attack or non-fatal stroke.
The overall safety profile of Jardiance was consistent with that of previous trials.
What is JARDIANCE? (www.jardiance.com)
JARDIANCE is a prescription medicine used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.
JARDIANCE is also used to reduce the risk of cardiovascular death in adults with type 2 diabetes who have known cardiovascular disease.
JARDIANCE is not for people with type 1 diabetes or for people with diabetic ketoacidosis (increased ketones in the blood or urine).