Jardiance (Empagliflozin) Demonstrates Significant Reduction in All-Cause Hospitalization Risk Compared to DPP-4 Inhibitors in Real-World Evidence from EMPRISE Study

March 30, 2019 News /BioValleyBIOON/ -- Boehringer IngelheimEli LillyDiabetesThe Alliance recently announced the preliminary results of EMPRISE, a large-scale real-world study of the glucose-lowering drug Jardiance (empagliflozin). The study included approximately 35,000 patients with type 2 diabetes between August 2014 and September 2016.DiabetesAnalysis of patient data revealed that, in routine clinical practice in the United States, Jardiance was associated with a 22% reduction in the relative risk of all-cause hospitalization compared with dipeptidyl peptidase-4 (DPP-4) inhibitor glucose-lowering agents. Among hospitalized patients, those treated with Jardiance were discharged earlier than those treated with DPP-4 inhibitors.

The results also indicated that, compared with DPP-4 inhibitors, Jardiance was associated with a significant reduction in emergency department visits and follow-up visits to internal medicine physicians. These preliminary findings were based on data observed during the first two years of the EMPRISE real-world evidence study. The data were presented at the 2019 Academy of Managed Care Pharmacy (AMCP) Annual Meeting held in San Diego, United States.

These preliminary results support the data from the landmark EMPA-REG OUTCOME study, which showed that in patients with type 2 diabetes and established cardiovascular diseaseDiabetesAmong patients, Jardiance reduced the relative risk of all-cause hospitalization by 11%.

Mehdi Najafzadeh, Co-Principal Investigator of the EMPRISE study and Instructor at Harvard Medical School, stated, “Compared with non-DiabetesCompared with non-diabetic patients, individuals with diabetes are more likely to be hospitalized for various reasons, experience longer hospital stays, and incur higher costs, which may have a significant impact on healthcare resources. Preliminary results from the EMPRISE real-world study indicate that Jardiance is associated with a reduced relative risk of hospitalization and shorter hospital stays in patients with type 2 diabetes.

Preliminary efficacy and safety data from the EMPRISE study were also recently presented at the 68th Annual Scientific Session of the American College of Cardiology (ACC) held in New Orleans, USAMeetingpublished. The results indicated that, compared with DPP-4 inhibitors, Jardiance was associated with a 42% reduction in hospitalization for heart failure or all-cause mortality. Furthermore, compared with DPP-4 inhibitors, Jardiance was not associated with a statistically significant increase in the risk of fracture or lower-limb amputation. These findings support the data from the EMPA-REG OUTCOME study, which demonstrated that in patients with type 2 diabetes and established cardiovascular disease, Jardiance reduced the relative risk of hospitalization for heart failure or cardiovascular death by 34%, without any imbalance in fractures or lower-limb amputations.

Jardiance (empagliflozin) belongs to the class of sodium-glucose cotransporter-2 (SGLT-2) inhibitors. Emerging SGLT-2 inhibitors have been proven to block glucose reabsorption in the kidneys, excreting excess glucose from the body, thereby achieving blood glucose-lowering effects. Moreover, this hypoglycemic effect is independent of β-cell function and insulin resistance.

Notably, Jardiance is the first type 2 diabetes medication to include data on reducing the risk of cardiovascular death in its drug labeling. In the United States, Jardiance was approved by the FDA for marketing in August 2014, as an adjunct to diet and exercise, to improve glycemic control in patients with type 2 diabetes. At the end of 2016, Jardiance received furtherFDAApproved for use in patients with type 2 diabetes and comorbid cardiovascular disease to reduce the risk of cardiovascular death. This approval makes Jardiance the first glucose-lowering medication approved globally to reduce the risk of cardiovascular death in patients with type 2 diabetes. It is well established that diabetes increases the risk of heart disease in patients,Stroke...and the risk of other diseases; conversely, cardiovascular complications can also significantly impact the physical health and life expectancy of patients with diabetes.

It is estimated that globally, approximately 50% of deaths in patients with type 2 diabetes are caused by cardiovascular disease; in the United States, this proportion is as high as two-thirds. Therefore, there is an urgent need in this field for a diabetes medication that can effectively reduce the risk of this complication. Consequently, the approval of Jardiance for its new indication marks a significant milestone in the clinical management of patients with type 2 diabetes and concurrent cardiovascular disease.

Since its market launch, Jardiance has experienced rapid sales growth, with global sales surpassing the $1 billion mark in 2017. In June 2018, the pharmaceutical market research firm EvaluatePharma released a report predicting that Jardiance’s global sales would reach $3.51 billion by 2024, making it the best-selling SGLT-2 inhibitor worldwide and the third best-selling antidiabetic drug globally. (Bioon.com)

Original Source:Initial results from the EMPRISE real-world study of empagliflozin compared with DPP-4 inhibitors presented at ACC.19 and AMCP 2019