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The first results of the study Real Estate World of the Zodiac



Zadine®, 44% relative risk of hospitalization for heart failure versus DPP-4 inhibitors, whether they had cardiovascular disease or not

The main results of the EMPA-REG OUTCOME study showed a 35% reduction in the relative risk of hospitalization for heart failure in patients with type 2 diabetes with cardiovascular disease® Assess the results of clinical studies


Borling Inglheim and Eileen Lilly® (EMPAGLIPLOSIN EFFECTIVE EFFECT AND SAFETY EFFECT) EFFECT OF EMPAGLILOPIN (SAFE) The results of the first American Heart Association (AMC) validation study conducted in the United States, November 10-12, AHA) at the annual conference.

The first analysis of the EMPRES study, based on data of about 35,000 people with type 2 diabetes from August 2014 to September 2016,®Showed a 44% reduction in relative risk of hospitalization for congestive heart failure (HHF) compared to DPP-4 inhibitors in the actual clinical setting in the United States.

These results indicate that empolyglobulin combined with standard treatments in type 2 diabetic patients with cardiovascular disease reduces the relative risk of cardiac hospitalization compared with placebo in 35% of EMPA-REG OUTCOME® It is believed to support the outcome of clinical research.

"In the United States, more than one million hospitalizations occur every year," Dr. Elisabeth Paterno, a professor of medicine and pharmacology at Harvard Medical School, Brigham Women's Hospital and the research firm, said. In this mode, EMPA-REG OUTCOME® "It is very important to ensure that the relative effect of the reduction in the risk of epilegotic heart failure, observed in clinical trials, also applies to clinical practice." The first analysis of the EMPRES study showed that empagoliprozine regardless of the presence of a history of cardiovascular disease was associated with a reduced risk of hospitalization for heart failure, "he said.

The EMPRES study will work until 2019 to assess the first use of empagloflozin in amergoloposin in the United States, and the results of the study include Empargillipple inhibitors versus DPP-4 inhibitors from 2014 to 2019. Rozin's relative efficacy, safety and clinical features such as health resource utilization and costs will be included.

This first analysis of the EMPRES study is based on data collected from August 2014 to September 2016. The results of the study will be updated as further data are available, and the safety results of the study will be published later. The EMPRISE study is part of an academic collaboration between Boehringer Ingelheim and Brigham Women's Hospital, the Harvard School of Medicine and the Brigham Women's Hospital at the Pharmacokinomics School are a leading study.

Dr. Waheed Jamal, Vice President of Boehringer Ingelheim and Head of the Cardiovascular Disease Department of Cardiovascular Disease, said: "The implications of the real EMPRES study are: EMPA-REG OUTCOME® "The main analysis of the EMPRISE study shows that empagoliprozine is a potent antagonist of DPP-4 inhibitors, and that it is important to understand how clinical studies can reduce the burden of cardiovascular disease suggesting that it may provide cardiovascular benefits to patients with type 2 diabetes, regardless If they have cardiovascular disease.

By the end of the study, the EMPRISE study is expected to analyze data from a total of more than 200,000 people with type 2 diabetes from both private healthcare providers in the US and Medicare, the US healthcare system. Additional EMPRES studies, including Asia and Europe, will also be conducted in 2019 to provide implications for the clinical benefits of amphotoloposin in actual clinical sites in different regions.

"Boehringer Ingelheim and Lilly are collaborating in diabetes to identify the clinical characteristics of ampagllofloxine for a wide range of cardiovascular risk factors in type 2 diabetic patients," said Dr. Sherry Martin, vice president of Lilly's diabetes department. "This analysis of the EMPRES study supports the cardiovascular outcomes of the EMPA-REG OUTCOME clinical trials, with the need for better treatment options to prevent hospitalization in patients with congestive heart failure. This is very encouraging. Boehringer Ingleheim and Lilly hope to share further results from the EMPRISE study and will try to expand their understanding of the potential benefits of Empagolloflozine in this area.

In the meantime, Boringer Inglheim and Lilly are working on two large-scale clinical research programs focused on reducing morbidity and mortality, while increasing the outcomes of patients with congestive heart failure as part of the needless demand. The EMPEROR HF clinical trial program consists of two Phase III clinical trials evaluating Empagliflozin as a treatment for adult heart failure and targeting not only type 2 diabetes patients with heart failure but also patients with heart failure who do not have diabetes. In addition, the EMPERIAL clinical trial consists of two phase III clinical trials evaluating the effect of Empaglyflozin on motor function and heart failure symptoms in patients with chronic heart failure, regardless of type 2 diabetes.

On EMPRES research1

The EMPRES study provided data on the relative efficacy, safety and health of ampoulefrolin resources and expenditures versus DPP-4 inhibitors in patients with type 2 diabetes regardless of whether they had cardiovascular disease (EMPA-REG OUTCOME)® It started in 2016 to complete the results of clinical studies.

The EMPRES study will be conducted to assess the first five years of the use of ampagopoulops in the United States between 2014 and 2019. By the end of the study, two civilian medical institutions in the US and the US medical insurance system is expected to analyze data from a total of more than 200,000 people with type 2 diabetes from care.

Additional EMPRES studies, including Asia and Europe, will also be conducted in 2019 to provide implications for the clinical benefits of amphotoloposin in actual clinical sites in different regions. The EMPRES study is led by the Harvard School of Medicine and the Women's Hospital of the University of Brigham in the United States and is conducted within the framework of the academic collaboration of Boringer Inglheim and Brigham Hospital.

EMPA-REG OUTCOME® On clinical research2

EMPA-REG OUTCOME® Clinical studies are long-term, multi-national, randomized, double-blind, placebo-controlled trials in 42 countries with more than 7,000 patients with type 2 diabetes with cardiovascular disease.

EMPA-REG OUTCOME® Clinical studies have shown that®(10 mg or 25 mg once daily) + the effect of standard treatment was compared to standard placebo treatment. The standard treatment included hypoglycemics and cardiovascular drugs (including hypotensives and cholesterol-lowering drugs). The primary endpoint was defined as a time for initial occurrence of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke.

EMPA-REG OUTCOME® In clinical trials,®Were consistent with previous clinical studies.

On heart failure

Heart failure is a progressive disease that occurs when the pumping function of the heart (contraction function) does not provide enough blood to the body, which can weaken the brain and body and fatal consequences.7 Symptoms of heart failure include shortness of breath, edema (most common on the legs, feet and ankles), and fatigue, and 26 million people worldwide suffer from chronic heart failure.8.9 Heart failure is the most common hospitalization in the United States and Europe over the age of 65, with up to 45% of people diagnosed with heart failure diagnosed with heart failure at one year of death.9,10 In addition, heart failure is common in diabetics, but about half of patients with congestive heart failure do not have diabetes.9, 11, 12

References

1. Patorno E et al. AHA Scientific Seats 2018; Poster Sa1112 / 1112.

2. Zinman & Wenner, Lachin JM, et al. EMPA-REG OUTCOME investigators. Empagliflozin, cardiovascular results, and death in type 2 diabetes. 2015; 373 (22): 2117-28.

5. Phase III randomized, double-blind, randomized trial to evaluate the effect of 12 weeks of 1-day EMPAGLIFLOZIN 10 mg compared to placebo on ExeRcise and heart failure symptoms in patients with chronic HeArtFaiLure with a preserved emission fraction (HFpEF). : https://clinicaltrials.gov/ct2/show/NCT03448406?term=EMPERIAL&rank=1. Last entry date for October 2018.
6. Phase III randomized, double-blind, randomized trial to evaluate the effect of 12 weeks of 1-day EMPAGLIFLOZIN 10 mg compared to placebo on ExeRcise and heart failure symptoms in patients with chronic HeArtFaiLure with a preserved emission fraction (HFpEF). : https://clinicaltrials.gov/ct2/show/NCT03448406?term=EMPERIAL&rank=1. Last entry date for October 2018.

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

9. Ambrosy A. P., et al. Global health and the economic burden of hospitalizations for heart failure. J Am Coll Cardiol 2014. 1, 63 (12): 1123-33.

10. Ponikowski P, Anker SG, Alhabib KF, et al. Heart Failure: Prevention of disease and death around the world. Heart failure. 2014, 1 (1): 4-25.

11. Nancy C., et al. 2013 ACCF / AHA Guidelines for the management of congestive heart failure: A report by the American College of Cardiology Foundation / American Heart Association and the Power Association on Practice Guidelines.

12. Suskin N, et al. Glucose and insulin disorders are related to functional ability in patients with increased heart failure. Eur Heart 2000: 21: 1368-75.

14. World Health Organization. Diabetes: Fact Sheet # 39; 312. Available at www.who.int/mediacentre/factsheets/fs312/en/#. Last entry date is October 2018.

15. World Heart Association. Diabetes as a risk factor for cardiovascular disease. Available at: www.world-heart-federation.org/cardiovascular-health/cardiovascular-disease-risk-factors/diabetes. Last entry date is October 2018.

16. Heritage NJ et al. Mortality and Causes of Death in the WHO Multidisciplinary Study on Blood Vessel Diseases in Diabetes. Diabetologia. 2001, 44 (2): S14-21.9.

17. Inarson TR, Acse, Ludwig C, et al. The prevalence of cardiovascular disease in type 2 diabetes: a systematic review of scientific evidence from around the world in 2007-2017. CardiovascDiabetol. 2018, 17: 83.

18. Cooperation of emerging risk factors. The cardiomyopathy association numbers morbidity with mortality. JAMA. 314 (1): 52-60.

19. Davis MJ, D Alessiode, Fradkin J, et al. Management of hyperglycemia in type 2 diabetes, 2018. Consensus report of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD), Diabetes Treatment, 2018, dci180033.0033.

20. Data on the file. Boehringer Inglheim Pharmaceuticals Ltd

22. A European summary of the Jardiance® product features, approved in May 2018. Data on the file.

23. Jardiance® (full prescription information). Mexico; Boehringer Ingleheim Pharmaceuticals, Inc.; 2017


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