Thursday , February 25 2021

The first results of the Zodiac® EMPRISE Real World study



– Zadin®, A 44% relative risk of heart failure due to cardiac insufficiency against DPP-4 inhibitors, whether or not they have cardiovascular disease

The results of EMPRISE's real study, EMPA-REG, indicate that type 2 diabetes in patients with cardiovascular disease® Evaluate the results of clinical trials


Boehringer Ingelheim and Eileen Lilly® (EMPAGLIPLOSIN COMPARABLE EFFICIENCY AND SAFE ETHYL) EMPRISE (EMPAGLYLOPINE COMPARING EFFECTS AND SAFETY) Results from the First United States Heart Association (AMC) First-Round Validation Study, which took place from 10 to 12 November in Chicago, USA. AHA) annual conference.

The first analysis of the EMPRISE study, based on approximately 35,000 people with type 2 diabetes, from August 2014 to September 2016,®Compared with DPP-4 inhibitors, 44% reduction in cardiac failure (HHF) hospitalization was found in the actual clinical setting in the United States.

These results suggest that empoliglobulin in combination with standard therapy in patients with type 2 diabetes mellitus with cardiovascular disease reduces the relative risk of hospitalization for heart failure compared with placebo (secondary outcome) by 35% EMPA-REG RESULTS® This is assessed as a clinical trial.

Dr. Elisabetta Patorno, Associate Professor of Medicine and Pharmacology at the Harvard Medical School, Brigham Women's Hospital and research researcher, said: "There are more than one million hospitalized heart failure every year in the United States. In this situation, EMPA-REG RESULTS® "It is very important to confirm that the relative risk reduction of epiglottiolous heart failure observed in clinical trials is also applicable in clinical practice." The first analysis of the EMPRISE study showed that empagoliprosin, regardless of the history of cardiovascular disease, is associated with a reduction in the risk of hospitalization due to heart failure, "he said.

The EMPRISE real-world study will last until 2019 to assess the first 5 years of use of empagoloflozine in the United States and the results of the study include Empargillipple versus DPP-4 inhibition between 2014 and 2019. Raw efflux, safety and clinical signs, such as the use of healthcare resources and expenditures.

The first analysis of the EMPRISE study is based on data collected from August 2014 to September 2016. The results of the study will be updated as additional data will be available and the study safety results will be announced separately later. The EMPRISE study is part of the academic collaboration between the Boehringer Ingelheim and the Brigham Women's Hospital, and Harvard Medical School and Brigham Women's Hospital Pharmaco-geneomics are leading research.

Dr Waheed Jamal, vice president of Boehringer Ingelheim and Head of the Cardiovascular Unit, said: "The results of the EMPRISE real-world study are the results of EMPA-REG.® "The primary analysis of the EMPRISE study shows that empagoliprosin is a potent DPP-4 inhibitor antagonist and that it is important to understand how clinical trials can reduce the risk of cardiovascular disease, suggesting that it can provide cardiovascular benefits to patients with type 2 diabetes, regardless of it , or they have cardiovascular disease. "

At the end of the study, the EMPRISE study is expected to analyze data from a total of over 200,000 people with type 2 diabetes from two US private healthcare providers and Medicare, the US healthcare system. Additional EMPRISE studies, including Asia and Europe, will also be conducted from 2019 to ensure that the clinical efficacy of empagollofosin in the actual clinical sites of different regions is influenced.

"Boehringer Ingelheim and Lilly are collaborating in diabetes to identify the clinical features of ampaglofloxin in a variety of cardiovascular risk patients with type 2 diabetes," Dr. Dr. Serie Martin, Vice President of Lillia Diabetes Division. "The analysis of this EMPRISE study confirms the outcome of the EMPA-REG OUTCOME® clinical cardiac and cardiovascular system, as well as the need for better treatment options to prevent hospitalization in patients with heart failure." Boehringer Ingelheim and Lilly hope that the EMPRISE study will additional results will be obtained and they will seek to broaden their understanding of the potential potential benefits of empagollofosin in this area. "

Meanwhile, Boehringer Ingelheim and Lilly are working on two large-scale clinical research programs aimed at reducing morbidity and mortality, while increasing the outcome of patients with heart failure as it does not meet the required demand. The EMPEROR HF Clinical Program includes two Phase III clinical trials in which empagliplozine is evaluated as an adult chronic heart failure and is aimed not only at patients with type 2 diabetes who suffer from heart failure but also in patients with heart failure who no diabetes Additionally, the EMPERIAL clinical study program consists of two Phase III clinical trials evaluating the effects of Empaglyflozine on motor function and heart failure in patients with chronic heart failure regardless of type 2 diabetes.

About EMPRISE Research1

The EMPRISE trial provided data on the relative efficacy, safety and use of health care resources and expenditures for patients with type 2 diabetes, regardless of whether they had cardiovascular disease in the actual clinical environment, EMPA-REG RESULTS® It began in 2016 to complement the results of clinical trials.

The EMPRISE real-world study will be conducted to assess the first five years of the empagolloplase's US-based use from 2014 to 2019. At the end of the study, two US civilian medical institutions and the US Medi Medical Insurance System Medi are expected to analyze data from a total of over 200,000 people with type 2 diabetes from care.

Additional EMPRISE studies, including Asia and Europe, will also be conducted from 2019 to ensure that the clinical efficacy of empagollofosin in the actual clinical sites of different regions is influenced. The EMPRISE study is led by the Harvard Medical School and the Brigham Women's Hospital Drug Epigraphy Unit in Boston, USA, and is part of the academic collaboration between the Boehringer Ingelheim and the Brigham Women's Hospital.

EMPA-REG RESULTS® For clinical research2

EMPA-REG RESULTS® Clinical trials are long-term, multinational, randomized, double-blind, placebo-controlled studies in 42 countries with over 7,000 patients with type 2 diabetes mellitus with cardiovascular disease.

EMPA-REG RESULTS® Clinical trials show that®(10 mg or 25 mg once daily) + The standard treatment effect was compared with placebo + standard therapy. Standard therapy consisted of hypoglycaemic agents and cardiovascular agents (including hypotensive agents and cholesterol lowering drugs). The primary endpoint was defined as the time when the first occurrence of cardiovascular death, non-fatal myocardial infarction or unconscious stroke occurred.

EMPA-REG RESULTS® Clinical trials®According to previous clinical trials.

For heart failure

Heart failure is a progressive illness that occurs when the heart pumping function (constriction) can not provide enough blood to the body that can weaken the mind and body and potentially fatal consequences.7 Symptoms of heart failure are drainage, edema (most commonly in legs, legs and ankles) and fatigue, and 26 million people worldwide suffer from chronic heart failure.8.9 Heart failure is the most commonly used hospitalization in the United States and Europe over the age of 65 years and up to 45% of patients diagnosed with heart failure diagnosed with cardiac failure, which is a year of death.9.10 Moreover, heart failure is common in patients with diabetes, but about half of patients with heart failure do not have diabetes.9, 11, 12

References

1 Patorno E et al. AHA Scientific Session 2018; poster Sa1112 / 1112.

2 Zinman B, Wanner C, Lachin JM, et al. EMPA-REG RESULT Investigators. Empaglifosin, cardiovascular outcomes and mortality in type 2 diabetic patients. N Engl J. Med. 2015, 373 (22): 2117-28.

5 Phase III randomized double-blind study to evaluate the effect of 12-week treatment with 10 mg EMPAGLIFLOZIN over placebo, ExeRcise, and heart failure in patients with chronic HeartfaiLure with preserved excretion fraction (HFpEF)) Available at: https: // clinicaltrials .gov / ct2 / show / NCT03448406? term = EMPERIAL & rank = 1. Last used in October 2018.
6 Phase III randomized double-blind study to evaluate the effect of 12-week treatment with 10 mg EMPAGLIFLOZIN over placebo, ExeRcise, and heart failure in patients with chronic HeartfaiLure with preserved excretion fraction (HFpEF)) Available at: https: // clinicaltrials .gov / ct2 / show / NCT03448406? term = EMPERIAL & rank = 1. Last used in October 2018.

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

9 Ambrosy AP, et al. The global health and economic burden of heart failure hospitalization. J Am Coll Cardiol 2014 1; 63 (12): 1123-33.

10 Ponikowski P, Anker SG, Alhabib KF, et al. Heart Failure: Preventing Disease and Death in the World. ESC heart failure. 2014; 1 (1): 4-25.

11 Yancy CW., Et al. 2013 ACCF / AHA Guidelines for Heart Failure: Report of the Practice Guidance for the American College of Cardiology and the American Heart Association. J Am CollCardill. 62 (16): E147-e239.

12 Suskin N. et al. Glucose and insulin pathologies are associated with functional capacity in patients with congestive heart failure. Eur Heart J. 2000; 21: 1368-75.

14 World Health Organization. Diabetes: Factsheet No. 312. Available at: www.who.int/mediacentre/factsheets/fs312/en/#. Last used in October 2018.

15 World Heart Federation. Diabetes as a risk factor for cardiovascular disease. Available at: www.world-heart-federation.org/cardiovascular-health/cardiovascular-disease- risk factor / diabetes. Last used in October 2018.

16 Morrish NJ et al. Mortality and Causes of Death in the WHO International Disease Study on Diabetes. Diabetes 2001; 44 (2): S14-21.9.

17 Einarson TR, Acse, Ludwig C, et al. The prevalence of cardiovascular disease in type 2 diabetes: systematic examination of scientific evidence throughout the world 2007-2017. A year CardiovascDiabetol. 2018, 17: 83.

18 Co-operation of new risk factors. Cardiometabolic multiform morbidity association with mortality. JAMA 2015, 314 (1): 52-60.

19th Davies MJ, D & # 39; Alessiode, Fradkin J, et al. Treatment of hyperglycemia in type 2 diabetes, 2018. The American Diabetes Association (ADA) and the European Diabetes Research Association (EASD) Consensus Report. Diabetic care. 2018; dci180033.0033.

20 File data. Boehringer Ingelheim Pharmaceuticals, Inc.

22 Summary of the European Summary of Product Characteristics Jardiance®, approved May 2018.

23 Jardiance® (full signing information). Mexico; Boehringer Ingelheim Pharmaceuticals, Inc.; 2017


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