INGELHEIM, Germany & INDIANAPOLIS, Ind.--(BUSINESS WIRE)--Boehringer Ingelheim and Eli Lilly and Company (NYSE:LLY) today announced results from a new cost-effectiveness analysis of the EMPA-REG OUTCOME® trial in a subgroup of 2,250 people with type 2 diabetes and established cardiovascular disease who also have diabetic kidney disease.1 Results suggest that treatment with empagliflozin, in addition to standard of care, leads to fewer cardiovascular and renal events, and has the potential to be a cost-effective treatment option for people with type 2 diabetes and diabetic kidney disease from the perspective of payers in the US.1 The results were presented at the ISN World Congress of Nephrology 2019 on 13 April in Melbourne, Australia.
Currently, there are more than 425 million people living with diabetes worldwide, 30-40 percent of whom are at risk of developing diabetic kidney disease.2,3 Furthermore, one third of people with diabetic kidney disease are at risk of progressing to end-stage kidney disease.3 Type 2 diabetes and diabetic kidney disease independently increase the risk of developing cardiovascular disease, with up to 1.2 million deaths from cardiovascular disease attributed to impaired kidney function.4 This progression of diabetic kidney disease among people with type 2 diabetes imposes substantial medical care costs.4 Typically, high-income countries spend more than 2-3 percent of their annual healthcare budget on the treatment of end-stage kidney disease.4
“Diabetic kidney disease occurs in up to 40 percent of people living with type 2 diabetes, many of whom are at substantial risk of experiencing kidney failure. This places a huge burden, not only on the patient’s life and the lives of their loved ones, but also on healthcare systems,” said Waheed Jamal, MD, Corporate Vice President and Head of CardioMetabolic Medicine, Boehringer Ingelheim. “We are encouraged by this latest analysis of the EMPA-REG OUTCOME® trial, which suggests that empagliflozin has the potential to be a cost-effective treatment option for people with type 2 diabetes and diabetic kidney disease.”
Empagliflozin is not indicated for the prevention of kidney disease.
Cost effectiveness analysis is a conventional method of evaluating the economic impact of a treatment. The results were garnered using a simulation economic model to predict clinical events and estimated costs for the EMPA-REG OUTCOME® trial subgroup of patients with type 2 diabetes and established cardiovascular disease who also have diabetic kidney disease receiving empagliflozin with standard of care versus standard of care alone.1 The modeling and simulation of cost effectiveness was performed using the cost per episode of certain diabetes-related clinical events and health utilities in the US associated with these events. Patients receiving empagliflozin were predicted to experience fewer of these clinical events, including progression of albuminuria (presence of the protein albumin in the urine), composite renal outcomes, hospitalisation for heart failure and cardiovascular deaths. Additionally, patients taking empagliflozin with standard of care were projected to survive 1.37 years longer compared to standard of care alone. This sensitivity analyses showed that, from a US perspective, empagliflozin could be a cost effective option for 99 percent of people with type 2 diabetes and cardiovascular disease at a threshold of $100,000/quality-adjusted life years (QALYs).1*†
“Boehringer Ingelheim and Eli Lilly and Company are committed to addressing the high, unmet clinical need for additional therapies to reduce the risk of kidney disease progression and cardiovascular disease in people with kidney disease, irrespective of whether or not they have diabetes,” said Sherry Martin, M.D., Vice President, Medical Affairs, Lilly Diabetes. “We are looking forward to validating the results presented today with the patient outcomes in EMPA-KIDNEY, which investigates whether empagliflozin could help improve the lives of people living with kidney disease.”
In the landmark EMPA-REG OUTCOME® trial, empagliflozin showed promising results related to the reduction in the relative risk of new onset or worsening kidney disease.5 Based on these insights, Boehringer Ingelheim and Lilly have initiated an academic collaboration with the Medical Research Council Population Health Research Unit at the University of Oxford (MRC PHRU) to conduct EMPA-KIDNEY.6 The study investigates the effects of empagliflozin on the progression of kidney disease and the occurrence of cardiovascular death in people with established chronic kidney disease with and without diabetes. Recruitment for the trial started in 2019 with the first results expected in 2022.6
About diabetic kidney disease
Diabetic kidney disease is a progressive decline of kidney function over time that occurs in 30-40 percent of all people with diabetes.3 One third of people with diabetic kidney disease may develop end-stage kidney disease, also known as kidney failure.3 Once end-stage kidney disease is reached, affected individuals have to undergo kidney replacement treatments, such as chronic dialysis or kidney transplantation.7 Since there is currently no approved treatment available to specifically reduce kidney disease progression and cardiovascular death, the overarching unmet medical need for new treatment options for people with kidney disease is evident.
About EMPA-KIDNEY: The study of heart and kidney protection with empagliflozin6
EMPA-KIDNEY is a multinational randomised, double-blind, placebo-controlled clinical trial. It is designed to evaluate the effect of empagliflozin on clinically relevant outcomes: kidney disease progression and cardiovascular mortality risk. The primary outcome is defined as time to a first event of either a cardiovascular death or kidney disease progression, defined as end-stage kidney disease (the need for kidney replacement therapy such as, dialysis or kidney transplantation), a sustained decline in eGFR to <10mL/min/1.73m2, renal death or a sustained decline of ≥40 percent in eGFR from randomisation. EMPA-KIDNEY includes people with established chronic kidney disease both with and without diabetes receiving current standard of care.
The study is conducted in selected countries representing a global footprint and aims to randomise approximately 5,000 participants to receive either empagliflozin 10mg once daily or placebo, on top of standard of care.
About EMPA-REG OUTCOME® (NCT01131676)5
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 (10mg or 25mg 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.
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.8,9,10
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.
Please click on the following link for ‘Notes to Editors’ and ‘References’: http://www.boehringer-ingelheim.com/press-release/effectiveness-analysis-in-diabetic-kidney-disease-and-type-2-diabetes
* Quality-adjusted life years (QALYs) reflect a patient’s health by weighting life years lived with a health-related utility score, which puts a value on the reduction in a patient’s quality of life
† $100,000/QALY is the threshold for cost-effectiveness analysis in the US. This figure is based on an estimate of the cost-effectiveness of dialysis for chronic kidney disease