American College of Cardiology recommends empagliflozin as preferred SGLT2 inhibitor for adults with type 2 diabetes and established cardiovascular disease in new Expert Consensus Decision Pathway

INGELHEIM,Germany and INDIANAPOLIS,Ind.,Nov. 27,2018 -- A new Expert Consensus Decision Pathway issued by the American College of Cardiology (ACC) recommends empagliflozin as the preferred SGLT2 inhibitor for its proven benefit in reducing the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease. The recommendation,part of the ACC's first Expert Consensus Decision Pathway on novel therapies for cardiovascular risk reduction in adults with type 2 diabetes,was released today and published online in the Journal of the American College of Cardiology.[1] Empagliflozin is marketed by Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY).

The recommendation of empagliflozin is based on evidence from the landmark EMPA-REG OUTCOME® trial,which investigated the effects of empagliflozin compared with placebo when added to standard of care in adults with type 2 diabetes and established cardiovascular disease.[2] In addition to the ACC Expert Consensus Decision Pathway,the American Diabetes Association® (ADA) and European Association for the Study of Diabetes (EASD) recently published a Consensus Report recommending SGLT2 inhibitors,such as empagliflozin,to help manage cardiovascular outcomes in patients with type 2 diabetes.[3] Empagliflozin is also the only SGLT2 inhibitor recommended in the ADA 2018 Standards of Medical Care in Diabetes for reducing the risk of cardiovascular death in people with type 2 diabetes and established cardiovascular disease.[4] Worldwide,more than 50 treatment guidelines have been updated to include findings from the EMPA-REG OUTCOME trial® in their endorsement of type 2 diabetes treatments with proven cardiovascular benefits.[5]

"People with type 2 diabetes are at increased risk of serious cardiovascular complications and events,even when their blood sugar is under control,which is why a focus on reducing cardiovascular risk in people with diabetes is critical," said Waheed Jamal,M.D.,Corporate Vice President and Head of CardioMetabolic Medicine,Boehringer Ingelheim. "The ACC Expert Consensus Decision Pathway,along with the Consensus Report from the ADA and EASD,all now recommend that comprehensive cardiovascular care for adults with type 2 diabetes and established cardiovascular disease includes a treatment shown to improve cardiovascular outcomes in this population,such as empagliflozin. These recommendations reflect a fundamental shift in the management of type 2 diabetes,moving beyond glucose control to a broader strategy of comprehensive cardiovascular risk reduction."

The 2018 ACC Expert Consensus Decision Pathway emphasises the need for a collaborative treatment approach by healthcare providers to reduce cardiovascular risk and improve survival in people with type 2 diabetes,a growing public health epidemic.[1] People with diabetes are up to four times more likely to develop cardiovascular disease than those without diabetes,and cardiovascular disease is the leading cause of death associated with diabetes.[6],[7]

The ACC Expert Consensus Decision Pathway's recommendation of empagliflozin,along with those of the ADA and EASD,represents a shift towards a comprehensive and team-based approach for managing the overall health of people with type 2 diabetes. The ACC encourages cardiologists to work as part of a broad healthcare provider team including primary care,internal medicine and endocrinology physicians,as well as nurse practitioners,physician assistants,diabetes educators and pharmacists,to improve the care and outcomes of people with type 2 diabetes.[1]

"The EMPA-REG OUTCOME trial® ushered in a new era for managing type 2 diabetes. Now,cardiovascular risk reduction is prioritised as a primary goal of diabetes management," said Sherry Martin,Vice President,Medical Affairs,Lilly. "With the adoption of the ACC's Expert Consensus Decision Pathway and ADA-EASD Consensus Report,the cardiology community will have an important role as part of the healthcare team managing cardiovascular risk in people with type 2 diabetes."

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 Diabetes and Cardiovascular Disease

More than 425 million people worldwide have diabetes,of which over 212 million are estimated to be undiagnosed.[8]By 2045,the number of people with diabetes is expected to rise to 629 million people worldwide.[8]Type 2 diabetes is the most common form of diabetes,responsible for around 90 percent of diabetes cases in high-income countries.[8] Diabetes is a chronic condition that occurs when the body either does not properly produce,or use,the hormone insulin.[8]

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.[9],[10] People with diabetes are two to four times more likely to develop cardiovascular disease than people without diabetes.[10]In 2017,diabetes caused four million deaths worldwide,with cardiovascular disease as the leading cause.8 Approximately 50 percent of deaths in people with type 2 diabetes worldwide are caused by cardiovascular disease.[7],[11]

Having a history of diabetesat 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.[12]

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.[13],[14]

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.[15],[16],[17]

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 and Eli Lilly and Company

In January 2011,Boehringer Ingelheim and Eli Lilly and Company announced an alliance in diabetes that centers on compounds representing several of the largest diabetes treatment classes. The alliance leverages the strengths of two of the world's leading pharmaceutical companies. By joining forces,the companies demonstrate commitment in the care of people with diabetes and stand together to focus on patient needs. Depending on geographies,the companies either co-promote or separately promote the respective molecules each contributed to the alliance.

For more information on Boehringer Ingelheim and Eli Lilly and Company,please visit: https://photos.prnasia.com/prnk/20181126/2308745-1

[1]ACC ECDP reference

[2]Zinman B,Wanner C,Lachin JM,et al. Empagliflozin,Cardiovascular Outcomes,and Mortality in Type 2 Diabetes. N Engl J Med. 2015;373:2117-28.

[3]Davies MJ,D'Alessio DA,Fradkin J,et al. Management of hyperglycaemia in type 2 diabetes,2018. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetologia. 2018.

[4]American Diabetes Association. Standards of Medical Care in Diabetes—2018. Diabetes Care. 2018;41(Suppl 1):S1-S159

[5] Data on file.

[6]Beckman J,Creager M and Libby P. Diabetes and atherosclerosis: epidemiology,pathophysiology,and management. JAMA 2002;287:2570-81.

[7]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.

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

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

[10]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.

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

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

[13]Davies MJ,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.

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

[15]Jardiance® (empagliflozin) tablets U.S. Prescribing Information. Available at: http://docs.boehringer-ingelheim.com/Prescribing%20Information/PIs/Jardiance/jardiance.pdf. Accessed November 2018.

[16]European Summary of Product Characteristics Jardiance®,approved May 2018. Data on file.

[17]Jardiance®(Full Prescribing Information). Mexico; Boehringer Ingelheim Pharmaceuticals,Inc; 2017.

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