The interim analysis included 190,000 adults in the
'Heart failure is a leading cause of hospitalizations in the
In this new interim analysis, Jardiance was associated with a reduction in risk of hospitalization for heart failure of 41% compared with DPP-4 inhibitors and of 17% compared with GLP-1 receptor agonists. Risk for non-fatal atherosclerotic cardiovascular events-defined as non-fatal heart attack or stroke, hospitalization for unstable angina or coronary revascularization-was similar for those treated with Jardiance (14.6 events per 1,000 patient-years) compared with DPP-4 inhibitors (17.6 events per 1,000 patient-years). The risk was also similar for those treated with Jardiance (14.2 events per 1,000 patient-years) compared with GLP-1 receptor agonists (14.8 events per 1,000 patient-years).
In a second interim analysis of EMPRISE, which included more than 45,000 patients, Jardiance was associated with a significant reduction in all-cause hospitalizations, emergency department visits and physician's office visits compared with DPP-4 inhibitors.
Results from the EMPRISE real-world study in routine clinical care complement data from the landmark EMPA-REG OUTCOME trial, in which Jardiance showed a 35% relative risk reduction in hospitalization for heart failure compared with placebo in adults with type 2 diabetes and established cardiovascular disease. The EMPA-REG OUTCOME trial also showed a 38% relative risk reduction in cardiovascular death in those taking Jardiance versus placebo in the same population.
'We are pleased to see the three-year data for EMPRISE continues to complement findings from the EMPA-REG OUTCOME trial,' said
The effects of empagliflozin on heart failure-related outcomes and functional capacity in people with heart failure are being evaluated in the empagliflozin heart failure program. The program, which includes more than 9,500 adults with heart failure, including those with and without diabetes, consists of the EMPEROR-Reduced, EMPEROR-Preserved, EMPERIAL-Reduced, EMPERIAL-Preserved, EMPULSE and EMPA-VISION studies.
About EMPRISE (NCT03363464, EUPAS20677)5
EMPRISE was initiated in 2016 to complement the EMPA-REG OUTCOME trial results by providing data on the comparative effectiveness, safety, healthcare resource utilization and costs in routine clinical care compared with DPP-4 inhibitors in people with type 2 diabetes with and without cardiovascular disease. In addition, a sub-group analysis has provided data on the effectiveness of empagliflozin compared with GLP-1 receptor agonists.
The study will assess the first five years of Jardiance use in the
The EMPRISE study was initiated, and is being led, by academic partners from the
About EMPA-REG OUTCOME (NCT01131676)
EMPA-REG OUTCOME was a long-term, multicenter, randomized, 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 Jardiance (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 medication for the treatment of hypertension and hypercholesterolemia). 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 Jardiance was consistent with that of previous trials.
About Heart Failure
Heart failure is a progressive, debilitating and potentially fatal condition that occurs when the heart cannot supply adequate circulation to meet the body's demands for oxygenated blood or, to do so, requires increased blood volume leading to fluid accumulation (congestion) in the lungs and peripheral tissues. It is a widespread condition affecting 60 million people worldwide and expected to increase as the population ages. Heart failure is highly prevalent in people with diabetes; however, approximately half of all people with heart failure do not have diabetes.
Symptoms of heart failure include difficulty breathing, swelling - most commonly in feet, legs and ankles - and fatigue, among others. People with heart failure experience a substantial reduction in quality of life, approximately 76% of whom find it difficult to carry out usual activities. This is, in part, due to the limitation of physical activity.
There is a high unmet need in the treatment of heart failure, as approximately 50% of people diagnosed with heart failure will die within five years. Additionally, heart failure represents the most common cause of hospitalization among individuals aged 65 years and over in the
About Cardiorenal Metabolic Conditions
Cardiorenal metabolic conditions are a group of interconnected disorders affecting the heart, kidneys and endocrine system. In aggregate, these conditions are the leading cause of deaths worldwide, accounting for up to 20 million deaths annually. Conditions within this group include coronary artery disease, heart failure, chronic kidney disease and type 2 diabetes, among many others.
Emerging science on the link between the cardiorenal and metabolic systems supports taking a multidisciplinary approach toward diagnostic, preventive and therapeutic strategies for people living with these conditions. A team approach to optimize patient care by coordinating treatment of related comorbidities, including the use of emerging therapies with broad cardiorenal metabolic effects, may improve outcomes for people with serious chronic conditions such as these.
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Boehringer Ingelheim is one of the world's top 20 pharmaceutical companies. Headquartered in Ingelheim,
Boehringer Ingelheim concentrates on developing innovative therapies that can improve and extend patients' lives. As a research-driven pharmaceutical company, it plans in generations for long-term success. Its research efforts are focused on diseases with high, unmet medical need. In animal health, the company stands for advanced prevention.
In 2018, Boehringer Ingelheim achieved net sales of around
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This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Jardiance and reflects
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