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Empagliflozin reduces hospitalisation risk for heart-failure and cardiovascular death by 21 per cent, shows Boehringer Ingelheim’s Emperor-Preserved trial

With approval, Empagliflozin would become the first and only clinically-proven therapy to improve outcomes for the full spectrum of heart failure patients, regardless of ejection fraction

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The breakthrough results of Emperor-Preserved trial reveal that Empagliflozin reduces the combined relative risk of cardiovascular death or hospitalisation for heart failure by 21 per cent in adult patients who suffer from heart failure with preserved ejection fraction (HFpEF), with or without diabetes. The trial investigated Empagliflozin (10 mg) versus placebo. The results were presented at the ESC Congress 2021, the annual meeting of the European Society of Cardiology. The Emperor heart failure studies are part of Boehringer Ingelheim’s Empower clinical trial programme exploring the effect of Empagliflozin across a spectrum of cardio-renal-metabolic diseases, a company statement said.

It informed that heart failure with preserved ejection fraction occurs when the left ventricle of the heart is unable to fill properly, resulting in less blood being pumped to the body. Heart failure poses a significant global disease burden, more than 60 million patients worldwide have heart failure and half of them have Heart Failure with Preserved Ejection Fraction. For this condition, there has been no prior treatment, which has the potential to modify the underlying disease. The treatment consists of controlling risk-factors like blood pressure, kidney disease, anemia and diabetes. In terms of modifying the underlying disease, the Emperor-Preserved trial results provide the first conclusive evidence.

Further, according to the statement, in India, about one per cent to 1.5 per cent of the adult population is estimated to have heart failure. As per the InterCHF study, the death rate within one year of a heart-failure event, is higher in India than the global average, and is next only to Africa. The Trivandrum Heart Failure Registry suggested that nearly two in five Indian patients with heart failure with preserved ejection fraction die within three years of their first hospital admission. Further, some key pre-disposing factors for heart failure with preserved ejection fraction, including hypertension, anemia, obesity, diabetes and kidney disease, are considerably prevalent in the Indian population.

Speaking in this regard, Dr Shraddha Bhure, MD, Medical Director, Boehringer Ingelheim India, said, “Heart Failure with preserved ejection fraction is an outcome of heterogeneous diseases and complex underlying problems. It represents about one-third of all the heart failure cases diagnosed in India, whereas, globally, it represents nearly half of the heart-failure cases. This disparity in the Indian population is likely due to several possibilities, including relatively younger average age of our population, lower likelihood of health-assessment in female patients who are more predisposed to this disease, and lesser awareness about the disease and its care at multiple levels. The results of the Emperor-Preserved phase-III trial, which also included a fair patient representation from India, offers a new hope for patients with heart failure with preserved ejection fraction, which, so far, has been a difficult entity to treat effectively.”

The statement further notified that the Emperor-Preserved trial results add to the previous findings from the Emperor-Reduced phase-III trial, which showed that Empagliflozin significantly reduced the combined relative risk of cardiovascular death or hospitalisation for heart failure by 25 per cent, compared to placebo, in adult patients with heart failure with reduced ejection fraction (HFrEF), with or without diabetes.

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