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Jardiance lowered risk of hospitalization from acute kidney injury but increased risk of hospitalized from diabetic ketoacidosis compared with a DPP4 inhibitor in one interim analysis.
Jardiance (empagliflozin) reduced the risk of death and hospitalization for some patients with type 2 diabetes and established cardiovascular disease, according to interim results from a study published in the June 2021 of Diabetes. The results were also presented at the American Diabetes Association annual meeting in June.
This study, the real-world EMPRISE trial, studied the effectiveness, safety, and health care utilization of Jardiance, based on data from Medicare and two U.S. commercial claims datasets (2014 to 2019).
In an interim analysis using data from 2014 to 2018 (2014-2017 in Medicare), investigators identified 55,580 pairs of matched patients 18 years or older with type 2 diabetes initiating Jardiance or a DPP4 inhibitor. Safety outcomes included lower-limb amputations, bone fractures, diabetic ketoacidosis hospitalization, and acute kidney injury hospitalization.
Over a mean follow up of 6.3 months, patients taking Jardiance had a lower risk of acute kidney injury hospitalization and a similar risk of lower-limb amputations and fractures. But patients had an increased risk of diabetic ketoacidosis hospitalization compared with a DPP4 inhibitor.
Jardiance, which is marketed by Boehringer Ingelheim and Eli Lilly & Co., is a sodium-glucose co-transporter 2 (SGLT2) inhibitor approved to improve glycemic control in adults with type 2 diabetes and to reduce the risk of cardiovascular death.
The companies also provided additional analysis from the EMPRISE trial that included European data pooled with data from Israel and East Asia. This analysis showed Jardiance was associated with a 45% relative risk reduction in all-cause mortality, a 29% relative risk reduction in hospitalization for heart failure, and a 33% relative risk reduction in a composite end point including heart attack, stroke, and all-cause mortality.
“These results are positive and encouraging for patients, who will benefit from our continued focus on improving the outcomes for people with cardio-renal-metabolic diseases, like type 2 diabetes and heart failure,” Waheed Jamal, M.D., corporate vice president and head of cardiometabolic medicine, Boehringer Ingelheim, said in a statement.
The companies also recently released data from the EMPEROR-Preserved study, which found Jardiance reduces the risk of the composite of cardiovascular death or hospitalization for heart failure in adults, with or without diabetes, who live with heart failure with preserved ejection fraction.
The new results from the phase 3 EMPEROR-Preserved trial, when added to the EMPEROR-Reduced trial results, demonstrate Jardiance’s efficacy in all forms of heart failure regardless of ejection fraction, Boehringer Ingelheim and Lilly said in a press release.