The analysis of data from EMPA-REG OUTCOME arrives as the FDA weighs the future of these large trials.
Results derived from the cardiovascular outcomes trial for empagliflozin suggest that the drug could extend life for people with type 2 diabetes (T2D), with greater benefits for those who start taking the drug at younger ages. The analysis appears in the journal Circulation, the official journal of the American Heart Association.
Using actuarial methods and assuming the benefits of empagliflozin remain constant, the team led by Harvard biostatistician Brian Claggett, PhD, estimated that the therapy could extend life by between 1 and 4.5 years. They made their calculations based on data gathered from 7020 people who took part in EMPA-REG OUTCOME, the first trial that showed a T2D therapy was not simply safe but also had cardiovascular benefits.
The trial showed a 38% relative risk reduction in cardiovascular death and a 32% risk reduction in all-cause mortality among those with T2D and cardiovascular disease. Empagliflozin is a sodium glucose co-transporter 2 (SGLT2) inhibitor, and since the publication of EMPA-REG OUTCOME, competitors in the class have reported cardiovascular benefits.
In this new analysis, the survival benefit was greater for younger patients and diminished compared with placebo as the study patients aged: The mean differences between patients taking empagliflozin and those taking placebo were 4.5 years at age 45, 3.1 years at age 50, 2.5 years at age 60, 2.0 years at age 70, and 1 year at age 80.
“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,” Claggett said in a statement. “This latest analysis estimates that empagliflozin could prolong such a person’s life span by, on average, 2.5 years.”
The findings come as an FDA advisory committee gets ready to weigh the future of large cardiovascular outcomes trials like EMPA-REG OUTCOME. A meeting is set for October 24-25 to discuss the trials, which were required after concerns over the safety of rosiglitazone.
A report in Diabetes Care, whose authors included some of the leading scientists who worked on these trials, notes that although the round of trials have revealed unanticipated benefits, the high costs involved must be considered.
Empagliflozin is sold as Jardiance by Boehringer-Ingelheim and Eli Lilly, which funded the study.
Claggett B, Lachin JM, Hantel S, et al. Long-term benefit of empagliflozin on life expectancy in patients with type 2 diabetes mellitus and established cardiovascular disease. Circulation. 2018;138(15):1599-1601.