28 November 2018 - - A new Expert Consensus Decision Pathway issued by the American College of Cardiology 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, German drugmaker Boehringer Ingelheim and US-based Eli Lilly and Company (NYSE: LLY) said.

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.

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.

In addition to the ACC Expert Consensus Decision Pathway, the American Diabetes Association (ADA) and European Association for the Study of Diabetes recently published a Consensus Report recommending SGLT2 inhibitors, such as empagliflozin, to help manage cardiovascular outcomes in patients with type 2 diabetes.

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.

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.

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.

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.

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.

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.

More than 425 m people worldwide have diabetes, of which over 212 m are estimated to be undiagnosed.

By 2045, the number of people with diabetes is expected to rise to 629m people worldwide.

Type 2 diabetes is the most common form of diabetes, responsible for around 90% 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.

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.

People with diabetes are two to four times more likely to develop cardiovascular disease than people without diabetes.

In 2017, diabetes caused 4m deaths worldwide, with cardiovascular disease as the leading cause.

Approximately 50% of deaths in people with type 2 diabetes worldwide are caused by cardiovascular disease.

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.

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.

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 OUTCOMEtrial.