The risk of adverse cardiovascular (CV) outcomes for type 2 diabetes patients was found to be reduced, regardless of age, when Jardiance (empagliflozin; Boehringer Ingelheim and Lilly) was added to the patient’s standard care.
The finding comes from the long-term, multicenter, randomized, double-blind, placebo-controlled trial known as EMPA-REG OUTCOME, which included over 7,000 patients from 42 countries who had type 2 diabetes and CV disease. The study evaluated Jardiance 10mg or 25mg once daily added to standard of care vs. placebo added to standard of care. The primary endpoint was defined as time to first occurrence of CV death, non-fatal heart attack or non-fatal stroke.
Jardiance was associated with a 38% reduced risk of CV death when compared with placebo over a median of 3.1 years. This reduction was consistent when researchers examined results after patients were divided into 3 different age brackets: those <65 years, those aged 65–74, and those aged ≥75 years. However, there was no significant difference in the risk of non-fatal heart attack or non-fatal stroke.
The consistency of efficacy for empagliflozin among the different age brackets was mirrored in patients with varying degrees of LDL cholesterol levels. There was lack of statistical interaction between sub-groups at baseline (<70mg/dL; 70–<85mg/dL; 85–<100mg/dL; 100–115mg/dL; and >115mg/dL) and CV death, non-fatal heart attack or non-fatal stroke, indicating a consistent risk reduction between these groups. The safety profile of empagliflozin in the EMPA-REG OUTCOME trial was consistent with previous trials.
Additional information of the EMPA-REG OUTCOME trial will be presented the ADA 76th Scientific Sessions.
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