A blockbuster diabetes drug significantly reduced the risk of hospitalization and death in people with all types of heart failure, according to a large international study led by a researcher at Brigham and Women’s Hospital.
The clinical trial found that AstraZeneca’s drug Farxiga reduced cardiovascular death or worsening heart failure by 18 percent when compared with a placebo in 6,000 patients followed for a median of 2.3 years in 20 countries. Farxiga was first approved in 2014 for the treatment of type 2 diabetes and generated $1 billion in quarterly sales in the first three months of 2022.
Dr. Scott D. Solomon, a professor of medicine at Harvard Medical School and Brigham and Women’s, and principal investigator for the study, said a separate meta-analysis he helped conduct of more than 12,000 patients confirmed that Farxiga and a rival drug called Jardiance, sold by Boehringer Ingelheim and Eli Lilly and Co., decreases the number deaths, as well as urgent trips to hospitals.
“We now have really very definitive evidence that regardless of what type of heart failure a patient has, they would benefit from being on this class of drugs,’’ said Solomon. The studies were published in the New England Journal of Medicine, The Lancet, and Nature Medicine. Solomon helped present the findings at the European Society of Cardiology Congress in Barcelona over the weekend.
Heart failure, sometimes known as congestive heart failure, occurs when the heart muscle doesn’t pump blood as well as it should. Blood often backs up, and fluid can build up in the lungs, causing shortness of breath, fatigue, and swelling in the legs. The condition, which becomes more common with age, is the leading cause of hospitalization in people over 65 years old, according to the US Food and Drug Administration. It affects more than 650,000 in the United States each year.
Both Farxiga and Jardiance are known as SGLT2 inhibitors and cause the body to excrete sugar in urine. For reasons not entirely understood by scientists, Solomon said, the drugs also appear to slow the progression of heart failure. And that’s true for the two main groups of patients: those whose heart muscles don’t contract properly, and those whose muscles contract properly but whose chambers don’t relax. Both forms of the disease can diminish blood flow.
In February, the FDA allowed Jardiance, which had previously been approved for those patients whose heart muscles don’t contract properly, to be prescribed to all of them. Solomon said AstraZeneca has requested similar approval for Farxiga, which is only cleared for the first subset of heart failure patients. He expected the FDA to make a decision in the first half of 2023.
“Heart failure remains one of the leading causes of death worldwide with high unmet need for some 64 million people,’’ Mene Pangalos, AstraZeneca’s executive vice president overseeing research and development of biopharmaceuticals, said in a statement.
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