EMPRISE real-world evidence (RWE) gepresenteerd tijdens de American Heart Association2018


Empagliflozine is geassocieerd met een risicoreductie van 44% op hospitalisatie voor hartfalen (HHF) bij patiënten met type 2 diabetes (T2DM) met en zonder hart- en vaatziekten (HVZ).
Dit laat de eerste analyse zien van de EMPRISE real-world evidence (RWE) studie, welke wordt gepresenteerd tijdens het congres van de American Heart Association in november 2018.
Deze nieuwe data van ongeveer 35.000 patiënten ondersteunen de eerdere positieve resultaten uit de EMPA-REG OUTCOME studie waarin het relatieve risico op HHF met 35% afnam bij patiënten met T2DM en HVZ.


De EMPRISE studie is gestart in 2014 om inzicht te krijgen in het gebruik van empagliflozine in de dagelijkse praktijk in de VS voor wat betreft effectiviteit, veiligheid, gebruik gezondheidszorg en kosten in de periode 2014-2019.
Empagliflozine wordt in deze studie vergeleken met DPP-4 remmers bij patiënten met T2DM met en zonder hart- en vaatziekten.
Over de totale looptijd van de studie zullen de gegevens van ongeveer 200.000 Amerikaanse patiënten in de EMPRISE geanalyseerd worden. Vanaf 2019 zal het RWE-programma van empagliflozine worden uitgebreid met gegevens van patiënten uit Azië en Europa.

Empagliflozine is geïndiceerd voor de behandeling van ongecontroleerde type 2 diabetes, waaronder naast bloedglucoseverlaging ook het verminderen van cardiovasculaire events wordt verstaan.

Initial results from EMPRISE real-world evidence study shows empagliflozin was associated with reduced risk for hospitalisation for heart failure in people with type 2 diabetes with and without cardiovascular disease


  • Empagliflozin was associated with a reduced relative risk of hospitalisation for heart failure (HHF) by 44 percent compared with commonly used dipeptidyl peptidase-4 inhibitors[i]
  • Effect of empagliflozin on HHF was consistent in patients with and without established cardiovascular disease1
  • Findings support data from the landmark EMPA-REG OUTCOME® trial, in which empagliflozin reduced the relative risk of HHF by 35 percent in people with type 2 diabetes and established cardiovascular disease[ii]


Ingelheim, Germany, November 5, 2018 – Empagliflozin is indicated for the treatment of uncontrolled Type 2 diabetes, which includes the reduction of cardiovascular events. Empagliflozin was associated with a 44 percent relative risk reduction in hospitalisation for heart failure (HHF) compared with dipeptidyl peptidase-4 (DPP-4) inhibitors in routine clinical practice in the U.S., according to initial effectiveness results from the real-world EMPagliflozin compaRative effectIveness and SafEty (EMPRISE) study. The EMPRISE analysis of data from approximately 35,000 people with type 2 diabetes between August 2014 and September 2016 will be presented at the American Heart Association® (AHA) Scientific Sessions 2018 in Chicago, Boehringer Ingelheim announced.


These results support findings from the landmark EMPA-REG OUTCOME® trial, which showed a 35 percent relative risk reduction in HHF (a secondary endpoint), with empagliflozin compared with placebo, when added to standard of care, in people with type 2 diabetes and established cardiovascular disease.1,2


The full EMPRISE real-world evidence study will provide a clinical picture of empagliflozin in routine clinical care including comparative effectiveness, safety and healthcare resource utilisation and cost outcomes compared with commonly used DPP-4 inhibitors between 2014 and 2019. Early findings from EMPRISE, which at completion will assess the first five years of empagliflozin use in the U.S. through 2019, represent data collected between August 2014 and September 2016. The efficacy findings will be updated as more data are gathered. Safety data from EMPRISE are not yet available and will be presented at a future time. EMPRISE was initiated, and is being led by academic partners from the Division of Pharmacoepidemiology at Brigham and Women’s Hospital and Harvard Medical School. The study is part of an academic collaboration between Brigham and Women’s Hospital and Boehringer Ingelheim.


“Insights from the EMPRISE real-world evidence study are critical in today’s healthcare landscape to understand how gold standard clinical trials, such as the EMPA-REG OUTCOME® trial, can reduce the burden of cardiovascular disease in patients seen in everyday clinical practice,” said Waheed Jamal, MD, Corporate Vice President and Head of CardioMetabolic Medicine, Boehringer Ingelheim. “Initial results from EMPRISE suggest that, compared with DPP-4 inhibitors, empagliflozin provides cardioprotective benefits in people with type 2 diabetes with and without cardiovascular disease.”


By study completion, EMPRISE is expected to have analysed health records of more than 200,000 people with type 2 diabetes from two commercial U.S. healthcare providers and Medicare.

From 2019, additional EMPRISE studies including Asia and Europe will provide insights from different regions of the world with an international perspective on the benefits of empagliflozin in routine clinical care.



EMPRISE was initiated in 2016 to complement the EMPA-REG OUTCOME trial results by providing data on the comparative effectiveness, safety, healthcare resource utilisation and costs in routine clinical care compared with DPP-4 inhibitors in people with type 2 diabetes with and without cardiovascular disease.


The study will assess the first five years of empagliflozin use in the U.S. between 2014 to 2019. Over 200,000 people with type 2 diabetes from two commercial U.S. healthcare providers and Medicare are projected to be included by study completion.

From 2019, additional EMPRISE studies including Asia and Europe will provide insights from different regions of the world with an international perspective on the benefits 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, USA.


About EMPA-REG OUTCOME (NCT01131676)2

EMPA-REG OUTCOME was a long-term, multicenter, 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.


About Heart Failure
Heart failure is a progressive, debilitating and potentially fatal condition that occurs when the heart cannot pump enough blood around the body.[iii] Symptoms of heart failure include difficulty with breathing, swelling – most commonly in feet, legs and ankles – and fatigue, among others.[iv] Heart failure is a prevalent disease; 26 million people around the world have chronic heart failure.[v] There is a high unmet need in the treatment of heart failure, as approximately 50 percent of people diagnosed with heart failure will die within five years.[vi] Additionally, heart failure represents the most common cause of hospitalisation among individuals aged 65 years and over in the United States and Europe.9 Heart failure is highly prevalent in people with diabetes, but approximately half of all people with heart failure do not have diabetes.9,[vii],[viii]


About Diabetes and Cardiovascular Disease

More than 425 million people worldwide have diabetes, of which over 212 million are estimated to be undiagnosed.[ix] By 2045, the number of people with diabetes is expected to rise to 629 million people worldwide.13 Type 2 diabetes is the most common form of diabetes, responsible for around 90 percent of diabetes cases in high-income countries.13 Diabetes is a chronic condition that occurs when the body either does not properly produce, or use, the hormone insulin.13


Due to the complications associated with diabetes, such as high blood sugar, high blood pressure and obesity, cardiovascular disease is a major complication and the leading cause of death associated with diabetes.[x],[xi] People with diabetes are two to four times more likely to develop cardiovascular disease than people without diabetes.15 In 2017, diabetes caused four million deaths worldwide, with cardiovascular disease as the leading cause.13 Approximately 50 percent of deaths in people with type 2 diabetes worldwide are caused by cardiovascular disease.[xii],[xiii]


Having a history of diabetes at age 60 can shorten a person’s life span by as much as six years compared with someone without diabetes. And having both diabetes and a history of heart attack or stroke by age 60 can shorten a person’s life span by as much as 12 years compared with someone without these conditions.[xiv]


More than 50 guidelines have been updated to endorse type 2 diabetes agents with proven cardiovascular benefits since 2016, including a recent Consensus Report initiated by the American Diabetes Association® and European Association for the Study of Diabetes, recommending that, in patients with type 2 diabetes and established atherosclerotic cardiovascular disease, SGLT2 inhibitors (such as empagliflozin) or GLP1 receptor agonists with proven cardiovascular benefits are recommended as part of glycaemic management.[xv],[xvi]


About Empagliflozin
Empagliflozin (marketed as Jardiance®) is an oral, once daily, highly selective sodium glucose cotransporter 2 (SGLT2) inhibitor and the first type 2 diabetes medicine to include cardiovascular death risk reduction data in the label in several countries.


Inhibition of SGLT2 with empagliflozin in people with type 2 diabetes and high blood sugar levels leads to excretion of excess sugar in the urine. In addition, initiation of empagliflozin increases excretion of salt from the body and reduces the fluid load of the body’s blood vessel system (i.e. intravascular volume). Empagliflozin induces changes to the sugar, salt and water metabolism in the body that may contribute to the reductions in cardiovascular death observed in the EMPA-REG OUTCOME® trial.



About Boehringer Ingelheim 
Improving the health and quality of life of patients is the goal of the research-driven pharmaceutical company Boehringer Ingelheim. The focus in doing so is on diseases for which no satisfactory treatment option exists to date. The company therefore concentrates on developing innovative therapies that can extend patients’ lives. In animal health, Boehringer Ingelheim stands for advanced prevention.


Family-owned since it was established in 1885, Boehringer Ingelheim is one of the pharmaceutical industry’s top 20 companies. Some 50,000 employees create value through innovation daily for the three business areas human pharmaceuticals, animal health and biopharmaceuticals. In 2017, Boehringer Ingelheim achieved net sales of nearly 18.1 billion euros. R&D expenditure, exceeding three billion euros, corresponded to 17.0 per cent of net sales.


As a family-owned company, Boehringer Ingelheim plans in generations and focuses on long-term success, rather than short-term profit. The company therefore aims at organic growth from its own resources with simultaneous openness to partnerships and strategic alliances in research. In everything it does, Boehringer Ingelheim naturally adopts responsibility towards mankind and the environment.

More information about Boehringer Ingelheim can be found on www.boehringer-ingelheim.com or in our annual report: http://annualreport.boehringer-ingelheim.com.

Intended audiences
This press release is issued from Boehringer Ingelheim Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where Boehringer Ingelheim does business.

[i] Patorno E et al. AHA Scientific Sessions 2018; poster Sa1112/1112.

[ii] Zinman B, Wanner C, Lachin JM, et al. EMPA-REG OUTCOME Investigators. Empagliflozin, cardiovascular outcomes, and mortality in type 2 diabetes. N Engl J Med. 2015;373(22):2117-28.

[iii] American Heart Association. What is Heart Failure? Available at: http://www.heart.org/HEARTORG/Conditions/HeartFailure/AboutHeartFailure/What-is-Heart-Failure_UCM_002044_Article.jsp#.WleEeLSFjBI. Last accessed October 2018.

[iv] Watson RDS, Gibbs CR, Lip GYH. Clinical features and complications. BMJ. 2000;320(7229):236-39.

[v] Ambrosy A.P., et al. The Global Health and Economic Burden of Hospitalizations for Heart Failure. J Am Coll Cardiol 2014. 1;63(12):1123-33.

[vi] Go AS, Mozaffarian D, Roger VL, Benjamin EJ, Berry JD, et al. Heart disease and stroke statistics—2013 update: a report from the American Heart Association. Circulation. 2013;127:e6-e245.

[vii] Yancy CW., et al. 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology Foundation/ American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 62(16):e147-e239.

[viii] Suskin N, et al. Glucose and insulin abnormalities relate to functional capacity in patients with congestive heart failure. Eur Heart J. 2000;21:1368-75.

[ix] International Diabetes Foundation. Diabetes Atlas 8th Edition. Available at: http://www.diabetesatlas.org. Accessed: October 2018.

[x] World Health Organisation. Diabetes: Fact Sheet no. 312. Available at: www.who.int/mediacentre/factsheets/fs312/en/#. Last accessed October 2018.

[xi] World Heart Federation. Diabetes as a Risk Factor for Cardiovascular Disease. Available at: www.world-heart-federation.org/cardiovascular-health/cardiovascular-disease-risk-factors/diabetes. Last accessed October 2018.

[xii] Morrish NJ et al. Mortality and Causes of Death in the WHO Multinational Study of Vascular Disease in Diabetes. Diabetologia. 2001;44(2):S14–21.9.

[xiii] Einarson TR, Acs A, Ludwig C, et al. Prevalence of cardiovascular disease in type 2 diabetes: a systematic literature review of scientific evidence from across the world in 2007–2017. Cardiovasc Diabetol. 2018;17:83.

[xiv] The Emerging Risk Factors Collaboration. Association of Cardiometabolic Multimorbidity With Mortality. JAMA. 2015;314(1):52-60.

[xv] Davies MJ, D’Alessio DA, Fradkin J, et al. Management of Hyperglycemia in Type 2 Diabetes, 2018. A Consensus Report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care. 2018;dci180033.0033.

[xvi] Data on file. Boehringer Ingelheim Pharmaceuticals, Inc.


Bron: Boehringer Ingelheim

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