EMPRISE: Empagliflozin demonstrates CV safety, efficacy in real-world population
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Two interim analyses of the EMPRISE study supported the effectiveness and CV safety of the SGLT2 inhibitor empagliflozin in real-world patients compared with DPP-IV inhibitors and GLP-1 receptor agonists.
These preliminary findings on the use of empagliflozin (Jardiance, Boehringer Ingelheim/Eli Lilly) were presented at American Diabetes Association Scientific Sessions. Healio previously reported on the initial results of empagliflozin compared with DPP-IV inhibitors.
“We are excited to present analyses from this large real-world study of Jardiance, including data on risks for heart failure hospitalization, all-cause mortality and major adverse cardiovascular events in adults with type 2 diabetes, as well as the efficacy and safety of Jardiance in people with type 2 diabetes who are 66 years or older — a notably vulnerable population,” Mohamed Eid, MD, MPH, MHA, vice president of clinical development and medical affairs in cardio-metabolism and respiratory medicine at Boehringer Ingelheim, said in a press release. “The findings also reinforce the efficacy and safety profile of Jardiance in people with type 2 diabetes. We look forward to seeing additional results from EMPRISE as part of our ongoing commitment to investigating the potential of Jardiance for people with cardio-renal-metabolic conditions.”
CV outcomes in older adult patients
For one of the analyses, researchers found that empagliflozin reduced the risk for HF hospitalization, both as a primary diagnosis at discharge (HHF-Specific) and as diagnosis of any sort at discharge (HHF-Broad), compared with DPP-IV inhibitors (HR for HHF-Specific = 0.43; 95% CI, 0.3-0.63; HR for HHF-Broad = 0.57; 95% CI, 0.47-0.69).
Empagliflozin also reduced the risk for major adverse CV events (HR = 0.63; 95% CI, 0.5-0.79) compared with DPP-IV inhibitors.
Compared with GLP-1 receptor agonists, empagliflozin reduced the risk for HF hospitalization (HR for HHF-Specific = 0.67; 95% CI, 0.50-0.91; HR for HHF-Broad = 0.83; 0.71-0.96), but conferred similar risk for major adverse CV events (HR = 1.02; 0.85-1.23).
For this analysis, researchers assessed data from the Medicare database between 2014 and 2017 to identify propensity score-matched patients of at least 66 years of age with type 2 diabetes and who initiated either empagliflozin, a DPP-IV inhibitor or a GLP-1 receptor agonist.
“Results for the individual components of MACE were consistent and robust to competing risks,” Elisabetta Patorno, MD, DrPH, assistant professor of medicine at Harvard Medical School and associate epidemiologist in the division of pharmacoepidemiology and pharmacoeconomics at Brigham and Women’s Hospital, and colleagues wrote in an abstract. “These findings, addressing the comparative effectiveness of empagliflozin in routine care patients with mean age of 72 years, complement available information from randomized controlled trials.”
Empagliflozin safety, efficacy in routine care
For the second interim analysis, using figures from Medicare and two commercial claims datasets from 2014 to 2017, investigators identified patients of at least 18 years of age with type 2 diabetes and who were initiating either empagliflozin or a DPP-IV inhibitor. Effectiveness outcomes included HF hospitalization, defined as discharge diagnosis in the primary or any position, a composite of MI and stroke and all-cause mortality. Safety outcomes included lower limb amputations, bone fractures, diabetic ketoacidosis and acute kidney injury.
Patorno and colleagues found that in this real-world population, empagliflozin reduced the risk for HF hospitalization (HR for HHF-Specific = 0.46; 95% CI, 0.3-0.73; HR for HHF-Broad = 0.63; 95% CI, 0.51-0.77) and all-cause mortality (HR = 0.52; 95% CI, 0.36-0.76) compared with DPP-IV inhibitors. However, there was no significant difference in risk for MI or stroke (HR = 0.89; 95% CI, 0.73-1.09).
In the analysis of safety outcomes, researchers observed that over a mean follow up of 178 days, empagliflozin conferred decreased risk for acute kidney injury (HR = 0.64; 95% CI, 0.53-0.77),increased risk for hospitalization for diabetic ketoacidosis (HR = 1.56; 95% CI, 1-2.44) and similar risk for lower-limb amputations (HR = 0.97; 95% CI, 0.67-1.42) and bone fractures (HR = 1.21; 95% CI, 0.81-1.81) compared with DPP-IV inhibitors.
“In routine care, empagliflozin had an effectiveness profile consistent with randomized controlled trial findings and safety outcomes in line with documented information,” the researchers wrote in an abstract.
Reference:
- Patorno E, et al. Clinical Therapeutics/New Technology — SGLT Inhibitors; 133-LB. Presented at: American Diabetes Association Scientific Sessions; June 12-16, 2020 (virtual meeting).
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Patorno E, et al. Clinical Therapeutics/New Technology — SGLT Inhibitors; 134-LB. Presented at: American Diabetes Association Scientific Sessions; June 12-16, 2020 (virtual meeting).
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