September 15, 2017
Three sub-analyses of the EMPA-REG OUTCOME® trial in people with type 2 diabetes and established cardiovascular disease* presented at EASD 20171-3; Irrespective of their blood sugar control at study start, participants* taking Jardiance® had a lower risk of cardiovascular death compared to placebo1; Jardiance® also reduced the risk of cardiovascular death compared to placebo regardless of background metformin or sulphonylurea use2-3
Ingelheim, Germany & Indianapolis, United States
New analyses of the landmark EMPA-REG OUTCOME® trial showed that Jardiance® (empagliflozin) reduced the risk of cardiovascular death in patients with type 2 diabetes and established cardiovascular (CV) disease*, independent of blood sugar control at the start of the study.1 A reduction in cardiovascular death was also seen when Jardiance® was added to common first and second-line diabetes medications, such as metformin or sulphonylurea.2,3 These results from post-hoc analyses were presented by Boehringer Ingelheim and Eli Lilly and Company (NYSE:LLY) at the 53rd Annual Meeting of the European Association for the Study of Diabetes (EASD) in Lisbon, Portugal.
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“Now that we have a new option for reducing the risk of cardiovascular death among people with type 2 diabetes, we are striving to better understand if there are differences in how patients can benefit,” said Prof. Silvio Inzucchi, Section of Endocrinology, Yale School of Medicine, New Haven, USA, who presented the data today. “These new analyses of the EMPA-REG OUTCOME® trial showed empagliflozin was effective in reducing the risk of cardiovascular death in patients with type 2 diabetes and established cardiovascular disease, no matter what the blood sugar levels at the start of the study were or if empagliflozin was added to commonly used oral blood sugar lowering treatments.”
In all four blood sugar level groups at study start (HbA1c levels of <7.0%, 7.0% to <8.0%, 8.0% to <9.0% and ≥9.0%), patients receiving Jardiance® demonstrated a reduction in the risk of cardiovascular death compared with placebo. This was consistent with the risk reduction seen in the overall trial population* and seen irrespective of whether blood sugar control was improved following introduction of the study treatment (as measured by a decrease in HbA1c level of ≥ 0.5% at week 12).1 Additional post-hoc analyses showed that when Jardiance® was added to metformin or sulphonylurea, the reduction of cardiovascular death compared to placebo was consistent with the overall trial population*. These analyses also showed the proportion of patients with hypoglycaemic adverse events were similar between the placebo and Jardiance® groups in the EMPA-REG OUTCOME® trial.2,3 The 7,020-patient EMPA-REG OUTCOME® trial results, first published in the New England Journal of Medicine in 2015, had shown that Jardiance® reduced the relative risk of cardiovascular death by 38 percent compared to placebo in patients with type 2 diabetes and established cardiovascular disease* on top of standard of care (including glucose-lowering agents and cardiovascular drugs). The overall safety profile of Jardiance® was consistent with that of previous clinical trials and current label information.4,5 “Cardiovascular disease is the primary cause of death in people with type 2 diabetes," said David Kendall, M.D., Distinguished Medical Fellow, Lilly Diabetes. “The results presented at EASD provide further evidence of the benefit empagliflozin can provide to patients with different background blood sugar control.” “The Boehringer Ingelheim and Eli Lilly Diabetes Alliance leads the paradigm shift in the treatment of people with type 2 diabetes”, said Dr Georg van Husen, Corporate Senior Vice President, Head of the Therapeutic Area CardioMetabolism, Boehringer Ingelheim. “The EMPA-REG OUTCOME® trial showed a remarkable reduction in CV death by 38% and the new data indicates that this effect is independent of the blood sugar control." About Empagliflozin Empagliflozin (marketed as Jardiance®) 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. 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 (i.e. sodium) and reduces the fluid load of the body’s blood vessel system (i.e. intravascular volume). The glucosuria, natriuresis and osmotic diuresis observed with empagliflozin may contribute to the improvement in cardiovascular outcomes.5 Empagliflozin is not for people with type 1 diabetes or for people with diabetic ketoacidosis (increased ketones in the blood or urine). About EMPA-REG OUTCOME®4 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. Over a median of 3.1 years, Jardiance® significantly reduced the risk of CV death, non-fatal heart attack or non-fatal stroke by 14 percent versus placebo. The risk of CV death was reduced by 38 percent, with no significant difference in the risk of non-fatal heart attack or non-fatal stroke. The overall safety profile of empagliflozin was consistent with that of previous trials. Intended audiences This press release is issued from Boehringer Ingelheim Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where Boehringer Ingelheim and Eli Lilly and Company do business. This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Jardiance and its safety profile, 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 Jardiance 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.