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Empagliflozin (Jardiance) Reduces Cardiovascular Risk in Diabetes Patients
Positive results have been announced from a long-term study that investigated cardiovascular (CV) outcomes for empagliflozin (Jardiance, Boehringer Ingelheim/Eli Lilly) in more than 7,000 adults with type-2 diabetes (T2D) at high risk for CV events.
Approximately 50% of deaths in people with T2D worldwide are caused by CV disease.
The randomized, double-blind, placebo-controlled EMPA-REG OUTCOME trial met its primary endpoint and demonstrated the superiority of empagliflozin, when added to standard of care, compared with placebo and standard of care in CV risk reduction. The primary endpoint was the time to the first occurrence of CV death, or nonfatal myocardial infarction or nonfatal stroke.
Detailed study results will be presented in September at the 51st annual meeting of the European Association for the Study of Diabetes, to be held in Stockholm, Sweden.
The more than 7,000 patients in the EMPA-REG OUTCOME trial were followed for a median period of 3.1 years. The study was designed to assess the effect of empagliflozin (10 mg or 25 mg once daily) added to standard of care compared with placebo added to standard of care on CV events in adults with T2D at high risk of CV events and with less than optimized blood glucose control. Standard of care consisted of glucose-lowering agents and cardiovascular drugs, including antihypertensive and lipid-lowering agents.
Empagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with T2D. It is not approved for the treatment of type-1 diabetes mellitus or diabetic ketoacidosis. In clinical studies, the most common adverse events associated with empagliflozin (5% or greater incidence) were urinary tract infections and female genital mycotic infections.
Sources: Lilly; August 20, 2015; and Jardiance Prescribing Information; June 2015.