EMA Approved Empagliflozin for the Treatment of Heart Failure Regardless of Left Ventricular Ejection Fraction
Prague, March 8, 2022 – Hundreds of thousands of patients in the Czech Republic can soon look forward to a treatment that may positively influence the progression of their disease. The European Medicines Agency (EMA) approved the registration of Jardiance® (empagliflozin) for the treatment of adults with symptomatic chronic heart failure with preserved left ventricular ejection fraction at the beginning of March. It thus becomes the first drug that doctors can prescribe to all patients, regardless of ejection fraction status. EMA had previously approved empagliflozin for the treatment of patients with chronic heart failure with reduced ejection fraction and for the treatment of adults with inadequately controlled type 2 diabetes. The drug was developed by Boehringer Ingelheim.
PRESS RELEASE
"It is important to note that heart failure with preserved or mildly reduced ejection fraction is an area where no drug has succeeded to the extent that empagliflozin has. The latest study is groundbreaking in that it is the first to show a significant effect and achieve the goal of reducing the number of patients who were hospitalized or died with heart failure with preserved ejection fraction," says Professor Filip Málek, MD, Ph.D., MBA, Chairman of the Czech Association of Heart Failure at the Czech Society of Cardiology.
The drug's registration is based on the results of the EMPEROR-Preserved randomized double-blind placebo-controlled clinical trial. Empagliflozin demonstrated a 21% reduction in relative risk regarding the composite outcome – death from cardiovascular causes or hospitalization due to heart failure, regardless of whether the patient has type 2 diabetes. The study involved 5,988 patients diagnosed with chronic heart failure.
"The significance of the study is even greater because it shows that patients with this type of heart failure account for at least half of all cases of this disease and are continually increasing in number. Until now, they have been commonly treated with drugs originally intended for a different type of heart failure; now we finally have a tool designed specifically for this diagnosis. In the Czech Republic, an estimated 300,000 patients suffer from heart failure, so approximately another 150,000 of them now see significant progress in treatment," adds Professor Aleš Linhart, MD, DrSc., Chairman of the Czech Society of Cardiology.
"This registration sets a new standard of care for millions of people across the European Union living with heart failure," continues Waheed Jamal, MD, Vice President of Boehringer Ingelheim. "We are also eagerly awaiting the results of the EMPA-KIDNEY study, which examines the potential of empagliflozin in treating chronic kidney disease," he adds.
Heart failure is often associated with other cardio-renal-metabolic diseases such as type 2 diabetes and kidney disease. Due to the connection of these systems, improvement in one can lead to positive effects in others. Patients with heart failure often experience shortness of breath and fatigue, which significantly affects their quality of life. It affects more than 60 million people worldwide and is the most common cause of hospitalization in Europe. The number of prevalent cases increases by an average of 9% year-over-year, and experts expect that with the increasing average age of the population, the number of these patients will continue to rise. According to estimates by Czech cardiologists, the number of people with heart failure could increase by up to 50% to approximately 450,000 by 2030. Diabetes mellitus is a significant risk factor for the development of heart failure and is often present in patients with already developed heart failure. According to studies, empagliflozin is effective both in preventing heart failure in patients with diabetes mellitus and in treating heart failure regardless of left ventricular ejection fraction in patients with and without diabetes.
About Boehringer Ingelheim
Boehringer Ingelheim develops breakthrough treatments that improve the health of people and animals. As one of the leading research-driven biopharmaceutical companies, it focuses primarily on creating value through innovation in areas where there have been no appropriate treatment options thus far. Since its foundation in 1885, Boehringer Ingelheim has remained a family-owned company, building on continuity and long-term experience. Approximately 52,000 employees work for the company in 130 markets across three business areas: human pharmaceuticals, animal health, and biopharmaceutical contract manufacturing. For more information, visit: www.boehringer-ingelheim.cz
About Empagliflozin
Empagliflozin (sold as Jardiance®) is an oral, once-daily, highly selective sodium-glucose cotransporter 2 (SGLT-2) inhibitor and the first medication for type 2 diabetes to provide data on reducing the risk of cardiovascular death in several countries.
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