Initial results from the EMPRISE real-world study of empagliflozin compared with DPP-4 inhibitors for treatment of Type 2 diabetes and CV risk

Boehringer Ingelheim and Eli Lilly and Company announced initial results from the EMPagliflozin compaRative effectIveness and SafEty (EMPRISE) real-world evidence study that show that empagliflozin is associated with a 22 percent relative risk reduction in all-cause hospitalisations, compared to DPP-4 inhibitors, within a mean follow-up of 5.4 months. Among those admitted to hospital, people treated with empagliflozin were discharged earlier compared to those treated with DPP-4 inhibitors (17,539 matched pairs in each treatment group). Results also show that empagliflozin is associated with significantly fewer recurrent emergency department visits and physician’s office visits compared to DPP-4 inhibitors.

These initial results, observed during the first two years of the EMPRISE real-world evidence study evaluating US-only data, were presented at the Academy of Managed Care Pharmacy (AMCP) Annual Meeting 2019 in San Diego, US. Initial EMPRISE results support data from the landmark EMPA-REG OUTCOME trial, which showed a relative risk reduction of 11 percent in all-cause hospitalisations with empagliflozin in people with type 2 diabetes and established cardiovascular disease.

“People with diabetes are more likely to be admitted to hospital from any cause than those without the condition, experiencing longer and more costly hospital stays. This can have a substantial impact on healthcare resources,” said Dr Mehdi Najafzadeh, PhD, MSc, MA, of the Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women’s Hospital and Instructor in Medicine, Harvard Medical School and study co-investigator. “Initial results from the EMPRISE real-world study show that empagliflozin is associated with a relative risk reduction in hospitalisations and with a shorter length of hospital stay for people with type 2 diabetes.”

Initial effectiveness and safety data from EMPRISE were also recently presented at the American College of Cardiology’s 68th Annual Scientific Session & Expo in New Orleans, US (ACC.19). Results show that empagliflozin was associated with a 42 percent relative risk reduction in hospitalisation for heart failure* or all-cause mortality compared to DPP-4 inhibitors, and was not associated with a statistically significant increased risk of bone fracture or lower leg amputation compared to DPP-4 inhibitors. These results support the findings from the EMPA-REG OUTCOME trial, which showed that empagliflozin reduced the relative risk of hospitalisation for heart failure or cardiovascular death in people with type 2 diabetes and established cardiovascular disease by 34 percent, with no imbalance with bone fractures or lower leg amputation.

About EMPRISE (NCT03363464, EUPAS20677): EMPRISE was initiated in 2016 to complement the EMPA-REG OUTCOME trial results and provide a comprehensive clinical picture of empagliflozin in routine care. By study completion, EMPRISE will provide insights into the comparative effectiveness, safety, healthcare resource utilisation and costs of empagliflozin, compared with DPP-4 inhibitors, in people with type 2 diabetes with and without cardiovascular disease in routine clinical care. The study will assess the first five years of empagliflozin use in the US between 2014 and 2019. Over 200,000 people with type 2 diabetes from two commercial US healthcare providers and Medicare are projected to be included by study completion. From 2019, additional EMPRISE studies including analyses of data from Asia and Europe will provide insights from different regions of the world with an international perspective on the use of empagliflozin in routine clinical care. The EMPRISE study was initiated, and is being led, by academic partners from the Division of Pharmacoepidemiology at Brigham and Women’s Hospital and Harvard Medical School, Boston, US. The study is part of an academic collaboration between Brigham and Women’s Hospital and Boehringer Ingelheim.

About EMPA-REG OUTCOME (NCT01131676): EMPA-REG OUTCOME was a long-term, multicentre, randomised, double-blind, placebo-controlled trial of more than 7,000 patients from 42 countries with type 2 diabetes and established cardiovascular disease. The study assessed the effect of empagliflozin (10 mg or 25 mg once daily) added to standard of care compared with placebo added to standard of care. Standard of care was comprised of glucose-lowering agents and cardiovascular drugs (including for blood pressure and cholesterol). The primary endpoint was defined as time to first occurrence of cardiovascular death, non-fatal heart attack or non-fatal stroke. The overall safety profile of empagliflozin was consistent with that of previous trials.