Boehringer Ingelheim's EMPA - REG Outcome long term trial improves understanding of Type 2 Diabetes and Cardiovascular diseases

Beirut, Lebanon – 2 July 2017-  Boehringer Ingelheim, one of the world’s leading pharmaceutical companies, held an event to launch their latest innovative type 2 diabetes treatment in Lebanon. The event brought together leading experts in internal medicine and primary care physicians to highlight the latest innovative, convenient medical solutions and findings in cardiovascular implications related to type 2 diabetes.

The leading experts also presented the latest findings of the EMPA-REG OUTCOME^® Trial, a dedicated cardiovascular outcomes trial in people with type-2 diabetes and established cardiovascular disease. The trial took place in 590 clinical sites in 42 countries with 7,020 participants and was observed for a median duration of 3.1 years. EMPA-REG OUTCOME^® Trial5   impressive results lead the major health authorities of the world, of which EMA AND FDA, to grant for the first time additional  indication for the reduction of the risk of  Cardiovascular death in T2D patients and established CVS diseases.  

The combination pill of Empagliflozin and Metformin hydrochloride – Synjardy is now available in Lebanon, to improve patient compliance and adherence to type 2 diabetes treatments and address the management of cardiovascular implications related to type 2 diabetes, reducing the relative risk of cardiovascular death, and offering more protection for patients, whilst reducing blood glucose, body weight and blood pressure in patients.

Today, healthcare professionals treating patients with type 2 diabetes in Lebanon can now prescribe this medication used to manage type 2 diabetes for those who are diabetic and have established cardiovascular disease. Despite advances in care, cardiovascular disease is still the number one cause of death among people with type 2 diabetes. In Lebanon, 47% of deaths are due to cardiovascular disease and is the primary reason for hospital admission due to a variety of social, economic and political factors.

The risk of dying from cardiovascular disease is up to four times higher in people with diabetes. Further, approximately one in two people with diabetes worldwide die due to cardiovascular disease.

Dr. Mounzer Saleh, Former President of the Lebanese Society of Endocrinology Diabetes and Lipids said, “The continuous change of lifestyle in Lebanon has led to striking increase in rates of type 2 diabetes. Lifestyle interventions and adherence to medications are central to disease prevention and management. Cardiovascular disease is the number one cause of death in people with type 2 diabetes worldwide and reducing cardiovascular risk, including death, is an essential component of diabetes care that was missing in older treatment interventions.’’

“The relationship between diabetes and CVD is complex; diabetes is a risk factor for CVD and conditions such as high blood pressure and obesity, that are more common in people with diabetes, are also risk factors for CV disease. Reducing cardiovascular risk is an essential component of diabetes management and so patients need to be better educated on how to modify cardiovascular risk factors in order to offer the best chance of improving CVD outcomes.’’ said Dr. Antoine Sarkis, Professor in Cardiology at the Hotel dieu de France Hospital, Beirut, Lebanon.

 Dr. Mounzer Saleh, also noted, “The complex interaction of risk factors for type 2 diabetes, makes it necessary to apply a holistic approach to the management of this chronic disorder. The latest treatments offered, JARDIANCE^® & SYNJARDY^®, are shifting the mind-set by not only focusing on lowering blood glucose levels in patients but also offering cardio-protection by reducing the relative risk of cardiovascular death by 38% on top of standard of care in adults with type 2 diabetes and established cardiovascular disease. Patient Knowledge of cardiovascular disease in Lebanon is scarce and so there is the need to work closely with the primary care service and government bodies, to obtain and align better outcomes for the population which has a high profile of cardiovascular risk factors.”

“The relationship between diabetes and CVD is complex; diabetes is a risk factor for CVD and conditions such as high blood pressure and obesity, that are more common in people with diabetes, are also risk factors for CV disease. Reducing cardiovascular risk is an essential component of diabetes management and so patients need to be better educated on how to modify cardiovascular risk factors in order to offer the best chance of improving CVD outcomes.’’ said Dr. Antoine Sarkis, Professor in Cardiology at the Hotel dieu de France Hospital, Beirut, Lebanon.

 Dr. Mounzer Saleh, also noted, “The complex interaction of risk factors for type 2 diabetes, makes it necessary to apply a holistic approach to the management of this chronic disorder. The latest treatments offered, JARDIANCE^® & SYNJARDY^®, are shifting the mind-set by not only focusing on lowering blood glucose levels in patients but also offering cardio-protection by reducing the relative risk of cardiovascular death by 38% on top of standard of care in adults with type 2 diabetes and established cardiovascular disease. Patient Knowledge of cardiovascular disease in Lebanon is scarce and so there is the need to work closely with the primary care service and government bodies, to obtain and align better outcomes for the population which has a high profile of cardiovascular risk factors.”

 Moreover, Fouad Jeweidi, Country Head Levant, Boehringer Ingelheim said, “Robust research & development (R&D) has always been the guiding principle that has enabled us to discover and develop innovative methods to help support patients manage type 2 diabetes more effectively. We continue to invest in R&D excellence through research and collaboration, a broad and growing product portfolio and a continued determination to provide real solutions, to ultimately make life better for all those affected by diabetes.”

Those who have type 2 diabetes have a higher risk of heart disease and stroke. Studies have shown that optimal blood glucose levels, along with the control of hypertension, weight loss and quitting smoking, are all necessary to reduce cardiovascular risks in type 2 diabetes patients. In particular, those who have diabetes and hypertension, the risk of cardiovascular disease doubles.Regular check-ups can help patients living with type 2 diabetes and help to reduce adverse outcomes such as cardiovascular diseases associated with diabetes.

About Boehringer Ingelheim

Innovative medicines for people and animals have for more than 130 years been what the research-driven pharmaceutical company Boehringer Ingelheim stands for. Boehringer Ingelheim is one of the industry’s top 20 pharmaceutical companies and to this day remains family-owned. Day by day, some 50,000 employees create value through innovation for the three business areas human pharmaceuticals, animal health and biopharmaceutical contract manufacturing. In 2016, Boehringer Ingelheim achieved net sales of around 15.9 billion euros. With more than three billion euros, R&D expenditure corresponds to 19.6 per cent of net sales.

 Social responsibility comes naturally to Boehringer Ingelheim. That is why the company is involved in social projects, such as the “Making More Health” initiative. Boehringer Ingelheim also actively promotes workforce diversity and benefits from its employees’ different experiences and skills. Furthermore, the focus is on environmental protection and sustainability in everything the company does. More information about Boehringer Ingelheim can be found on www.boehringer-ingelheim.com

About EMPA-REG OUTCOME^®

EMPA-REG OUTCOME^® was a long-term, multicentre, randomised, double-blind, placebo-controlled trial of more than 7,000 people from 42 countries with type 2 diabetes at high risk for cardiovascular events.

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.

Although the EMPA-REG OUTCOME^® trial was not designed to assess the potential mechanisms behind the effect of empagliflozin on kidney outcomes, the kidney assessment was part of a pre-specified exploratory analysis plan of additional endpoints.

The overall safety profile of empagliflozin was consistent with that of previous trials.