- The results of the EMPA-REG OUTCOME trial were published in the New England Journal of Medicine (Zinman et at. http://www.nejm.org/) and also presented at the 51st European Association for the Study of Diabetes Annual Meeting today
- Jardiance® achieved superiority for the primary CV endpoint and a significant reduction in CV death in people with T2D at high risk of CV events
BRACKNELL, UK I September 17, 2015 I A trial of Boehringer Ingelheim and Eli Lilly and Company’s (LLY) Jardiance® (empagliflozin) demonstrates it significantly reduced the risk of the combined endpoint of cardiovascular (CV) death, non-fatal heart attack or non-fatal stroke by 14 percent (compared to placebo1) in patients with type 2 diabetes (T2D) at high risk of CV events. All patients in the study received a background standard of care for cardiovascular disease. There was a significant 38 percent risk reduction in CV death, with no significant difference in the risk reduction of non-fatal heart attack or non-fatal stroke.
In addition, empagliflozin resulted in a risk reduction of all-cause mortality (32 percent reduction) and hospitalisation for heart failure (35 percent reduction).
“These results are both novel and exciting for the millions of people living with type 2 diabetes at risk for cardiovascular disease. Addressing the burden of cardiovascular events, including death, is at the core of diabetes care, and until now no single diabetes medication has been associated with a reduction in mortality,” said lead investigator of the trial Dr. Bernard Zinman, Director, Diabetes Centre, Mount Sinai Hospital; Senior Scientist, Lunenfeld Tanenbaum Research Institute, and Professor of Medicine, University of Toronto, Canada. Dr Zinamn went on to say, “In this study, empagliflozin was shown to prevent one out of three cardiovascular deaths.”
Patients with T2D have a two to four fold increased risk of CV eventsI. Approximately half of all patients with T2D will die from CV diseaseI,II. Diabetes can reduce life expectancy by up to 12 years in patients at high CV riskIII. The effect of empagliflozin in this trial was observed on top of standard of care. This means the benefit was seen over and above other treatments patients were already receiving for diabetes and/or cardiovascular disease (for example, three in four were on statins and over nine in 10 were on blood pressure medications).
The overall safety profile of empagliflozin was consistent with previous trials. The incidence of diabetic ketoacidosis in patients was below 0.1 percent and similar across all treatment groups.
“In total there are currently over 3.3 million people with diabetes in the UK. Every day a further 700 people are diagnosed. They will face many challenges. However, what often goes unreported is that it is cardiovascular events that are the number one cause of death. Reducing cardiovascular risk is therefore an essential component of diabetes management” said Prof. Klaus Dugi, Boehringer Ingelheim Medical Director, UK and Ireland.
Prof Dugi went on to say, “We believe that this trial data could be one of the significant advances in diabetes care comparable perhaps to the introduction of insulin by Eli Lilly over 90 years ago.”
These data were presented today at the 51st European Association for the Study of Diabetes Annual Meeting in Stockholm, Sweden, and simultaneously published in the New England Journal of Medicine (Zinman et at. http://www.nejm.org/)
About EMPA-REG OUTCOME®
EMPA-REG OUTCOME® was a long-term, multicentre, randomised, double-blind, placebo-controlled trial that involved more than 7,000 patients from 42 countries with type 2 diabetes at high risk for cardiovascular (CV) events. The primary outcome event was time to first occurrence of either CV death, or non-fatal heart attack or non-fatal stroke. There were 772 such primary outcome events in the EMPA-REG OUTCOME® trial over a median observation period of 3.1 years.
The study was designed to assess the effect of empagliflozin (10mg or 25mg once daily) added to standard of care compared with placebo added to standard of care. The primary endpoint was defined as time to first occurrence of either CV death, or non-fatal heart attack or non-fatal stroke. The study was designed to first test for non-inferiority and then for superiority of the primary endpoint compared to standard of care.
Standard of care was comprised of glucose-lowering agents and cardiovascular drugs (for example, three in four were on statins and over nine in 10 were on blood pressure medications).
More than 97 percent of patients completed the trial and vital status was available for more than 99 percent of patients who completed the study.
About Jardiance®
Jardiance® (empagliflozin) is an oral, once daily, highly selective sodium glucose cotransporter 2 (SGLT2) inhibitor approved for use in Europe, the United States and other markets around the world for the treatment of adults with type 2 diabetes.
Empagliflozin works by blocking the reabsorption of glucose (blood sugar) by the kidney, leading to urinary glucose excretion, and lowering blood glucose levels in people with type 2 diabetes. SGLT2 inhibition targets glucose directly and works independently of β-cell function and the insulin pathway.
Empagliflozin is not licensed for people with type 1 diabetes or for people with diabetic ketoacidosis (increased ketones in the blood or urine).
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 patients 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.
Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, Boehringer Ingelheim operates globally with 146 affiliates and a total of more than 47,700 employees. The focus of the family-owned company, founded in 1885, is researching, developing, manufacturing and marketing new medications of high therapeutic value for human and veterinary medicine.
Social responsibility is an important element of the corporate culture at Boehringer Ingelheim. This includes worldwide involvement in social projects, such as the initiative “Making more Health” and caring for the employees. Respect, equal opportunities and reconciling career and family form the foundation of the mutual cooperation. In everything it does, the company focuses on environmental protection and sustainability.
In 2014, Boehringer Ingelheim achieved net sales of about 13.3 billion euros. R&D expenditure corresponds to 19.9 per cent of its net sales.
For more information please visit www.boehringer-ingelheim.co.uk
About Lilly Diabetes
Lilly has been a global leader in diabetes care since 1923, when we introduced the world’s first commercial insulin. Today we are building upon this heritage by working to meet the diverse needs of people with diabetes and those who care for them. Through research and collaboration, a broad and growing product portfolio and a continued determination to provide real solutions—from medicines to support programs and more—we strive to make life better for all those affected by diabetes around the world. For more information, visit www.lillydiabetes.com.
About Eli Lilly and Company
Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at www.lilly.co.uk
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about empagliflozin as a treatment for patients with type 2 diabetes along with diet and exercise and reflects Lilly’s current belief. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. Among other things, there can be no guarantee that future study results will be consistent with the results to date or that empagliflozin will receive additional regulatory approvals. For further discussion of these and other risks and uncertainties, see Lilly’s most recent Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release.
References
1 The primary endpoint was as follows: “time to first occurrence of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke, analysed by empagliflozin (pooled dose groups) versus placebo”. The outcome was a Hazard Ratio of 0.86, meaning that there was a 14% relative risk reduction in time to first event.
I. Sarwar et al. Lancet 2010;375(9733):2215–2222
II. Seshasai et al. N Engl J Med 2011;364:829-41.
III. The emerging risk factors collaboration. JAMA. 2015;314(1):52-60.
IV. Diabetes UK. What is Diabetes https://www.diabetes.org.uk/Guide-to-diabetes/What-is-diabetes/ Accessed 15/09/2015
V. Diabetes UK. More than 700 a day diagnosed with diabetes https://www.diabetes.org.uk/About_us/News/More-than-700-a-day-diagnosed-with-diabetes/ Accessed 15/09/2015
SOURCE: Eli Lilly
Post Views: 29
- The results of the EMPA-REG OUTCOME trial were published in the New England Journal of Medicine (Zinman et at. http://www.nejm.org/) and also presented at the 51st European Association for the Study of Diabetes Annual Meeting today
- Jardiance® achieved superiority for the primary CV endpoint and a significant reduction in CV death in people with T2D at high risk of CV events
BRACKNELL, UK I September 17, 2015 I A trial of Boehringer Ingelheim and Eli Lilly and Company’s (LLY) Jardiance® (empagliflozin) demonstrates it significantly reduced the risk of the combined endpoint of cardiovascular (CV) death, non-fatal heart attack or non-fatal stroke by 14 percent (compared to placebo1) in patients with type 2 diabetes (T2D) at high risk of CV events. All patients in the study received a background standard of care for cardiovascular disease. There was a significant 38 percent risk reduction in CV death, with no significant difference in the risk reduction of non-fatal heart attack or non-fatal stroke.
In addition, empagliflozin resulted in a risk reduction of all-cause mortality (32 percent reduction) and hospitalisation for heart failure (35 percent reduction).
“These results are both novel and exciting for the millions of people living with type 2 diabetes at risk for cardiovascular disease. Addressing the burden of cardiovascular events, including death, is at the core of diabetes care, and until now no single diabetes medication has been associated with a reduction in mortality,” said lead investigator of the trial Dr. Bernard Zinman, Director, Diabetes Centre, Mount Sinai Hospital; Senior Scientist, Lunenfeld Tanenbaum Research Institute, and Professor of Medicine, University of Toronto, Canada. Dr Zinamn went on to say, “In this study, empagliflozin was shown to prevent one out of three cardiovascular deaths.”
Patients with T2D have a two to four fold increased risk of CV eventsI. Approximately half of all patients with T2D will die from CV diseaseI,II. Diabetes can reduce life expectancy by up to 12 years in patients at high CV riskIII. The effect of empagliflozin in this trial was observed on top of standard of care. This means the benefit was seen over and above other treatments patients were already receiving for diabetes and/or cardiovascular disease (for example, three in four were on statins and over nine in 10 were on blood pressure medications).
The overall safety profile of empagliflozin was consistent with previous trials. The incidence of diabetic ketoacidosis in patients was below 0.1 percent and similar across all treatment groups.
“In total there are currently over 3.3 million people with diabetes in the UK. Every day a further 700 people are diagnosed. They will face many challenges. However, what often goes unreported is that it is cardiovascular events that are the number one cause of death. Reducing cardiovascular risk is therefore an essential component of diabetes management” said Prof. Klaus Dugi, Boehringer Ingelheim Medical Director, UK and Ireland.
Prof Dugi went on to say, “We believe that this trial data could be one of the significant advances in diabetes care comparable perhaps to the introduction of insulin by Eli Lilly over 90 years ago.”
These data were presented today at the 51st European Association for the Study of Diabetes Annual Meeting in Stockholm, Sweden, and simultaneously published in the New England Journal of Medicine (Zinman et at. http://www.nejm.org/)
About EMPA-REG OUTCOME®
EMPA-REG OUTCOME® was a long-term, multicentre, randomised, double-blind, placebo-controlled trial that involved more than 7,000 patients from 42 countries with type 2 diabetes at high risk for cardiovascular (CV) events. The primary outcome event was time to first occurrence of either CV death, or non-fatal heart attack or non-fatal stroke. There were 772 such primary outcome events in the EMPA-REG OUTCOME® trial over a median observation period of 3.1 years.
The study was designed to assess the effect of empagliflozin (10mg or 25mg once daily) added to standard of care compared with placebo added to standard of care. The primary endpoint was defined as time to first occurrence of either CV death, or non-fatal heart attack or non-fatal stroke. The study was designed to first test for non-inferiority and then for superiority of the primary endpoint compared to standard of care.
Standard of care was comprised of glucose-lowering agents and cardiovascular drugs (for example, three in four were on statins and over nine in 10 were on blood pressure medications).
More than 97 percent of patients completed the trial and vital status was available for more than 99 percent of patients who completed the study.
About Jardiance®
Jardiance® (empagliflozin) is an oral, once daily, highly selective sodium glucose cotransporter 2 (SGLT2) inhibitor approved for use in Europe, the United States and other markets around the world for the treatment of adults with type 2 diabetes.
Empagliflozin works by blocking the reabsorption of glucose (blood sugar) by the kidney, leading to urinary glucose excretion, and lowering blood glucose levels in people with type 2 diabetes. SGLT2 inhibition targets glucose directly and works independently of β-cell function and the insulin pathway.
Empagliflozin is not licensed for people with type 1 diabetes or for people with diabetic ketoacidosis (increased ketones in the blood or urine).
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 patients 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.
Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, Boehringer Ingelheim operates globally with 146 affiliates and a total of more than 47,700 employees. The focus of the family-owned company, founded in 1885, is researching, developing, manufacturing and marketing new medications of high therapeutic value for human and veterinary medicine.
Social responsibility is an important element of the corporate culture at Boehringer Ingelheim. This includes worldwide involvement in social projects, such as the initiative “Making more Health” and caring for the employees. Respect, equal opportunities and reconciling career and family form the foundation of the mutual cooperation. In everything it does, the company focuses on environmental protection and sustainability.
In 2014, Boehringer Ingelheim achieved net sales of about 13.3 billion euros. R&D expenditure corresponds to 19.9 per cent of its net sales.
For more information please visit www.boehringer-ingelheim.co.uk
About Lilly Diabetes
Lilly has been a global leader in diabetes care since 1923, when we introduced the world’s first commercial insulin. Today we are building upon this heritage by working to meet the diverse needs of people with diabetes and those who care for them. Through research and collaboration, a broad and growing product portfolio and a continued determination to provide real solutions—from medicines to support programs and more—we strive to make life better for all those affected by diabetes around the world. For more information, visit www.lillydiabetes.com.
About Eli Lilly and Company
Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at www.lilly.co.uk
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about empagliflozin as a treatment for patients with type 2 diabetes along with diet and exercise and reflects Lilly’s current belief. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. Among other things, there can be no guarantee that future study results will be consistent with the results to date or that empagliflozin will receive additional regulatory approvals. For further discussion of these and other risks and uncertainties, see Lilly’s most recent Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release.
References
1 The primary endpoint was as follows: “time to first occurrence of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke, analysed by empagliflozin (pooled dose groups) versus placebo”. The outcome was a Hazard Ratio of 0.86, meaning that there was a 14% relative risk reduction in time to first event.
I. Sarwar et al. Lancet 2010;375(9733):2215–2222
II. Seshasai et al. N Engl J Med 2011;364:829-41.
III. The emerging risk factors collaboration. JAMA. 2015;314(1):52-60.
IV. Diabetes UK. What is Diabetes https://www.diabetes.org.uk/Guide-to-diabetes/What-is-diabetes/ Accessed 15/09/2015
V. Diabetes UK. More than 700 a day diagnosed with diabetes https://www.diabetes.org.uk/About_us/News/More-than-700-a-day-diagnosed-with-diabetes/ Accessed 15/09/2015
SOURCE: Eli Lilly
Post Views: 29
