AstraZeneca PLC said results from a sub-analysis of a late-stage trial of Farxiga, a medicine used to treat type 2 diabetes, showed it cut the likelihood of a cardiovascular event by 16% in high-risk patients and reduced the chances of hospitalization for heart failure in all patients with the disease.
Taking Farxiga cut hospitalizations for heart failure by 36% in patients with a reduced ejection fraction — a measure of how much blood the heart pumps out with each contraction. For those without reduced ejection fraction, the drop in hospitalizations was 24%.
Results from the trial, dubbed Declare-Timi 58, were presented at the American College of Cardiology meeting on March 18 and published in the medical journal Circulation. The full dataset of the trial of more than 17,000 patients across 882 sites in 33 countries was published in November 2018.
Farxiga belongs to a class of drugs known as SGLT-2 inhibitors — along with Johnson & Johnson's Invokana and Jardiance, made by Boehringer Ingelheim — and is approved to improve glycemic control in adults with type 2 diabetes. This class of drugs, also known as gliflozin drugs, work by absorbing glucose via the kidneys so that excess glucose is passed out of the body via urination.
"What Declare has shown is that we prevent heart failure," said Joris Silon, senior vice president of AstraZeneca's cardiovascular renal and metabolism unit, in an interview. "And that is the key takeaway because heart failure is a very severe and early complication — together with renal complications — for patients with type 2 diabetes."
Heart failure is one of the most common complications of type 2 diabetes and is more prevalent than the top four most common cancers, said Elisabeth Björk, senior vice president of late cardiovascular, renal and metabolism research and development at AstraZeneca. Although Farxiga is not approved to reduce the risk of cardiovascular events or heart failure, the data presented paves the way for further studies to expand its use.
"Our next step will be a trial ongoing in heart failure patients without diabetes," said Silon. "So we therefore don't only think this is a diabetes drug. We believe — and obviously, it's still an experiment, we need to see what the results say — that it might also help patients that have heart failure and don't have diabetes."
The U.K.'s second-largest pharmaceutical company has also applied to regulators around the world seeking approval for the use of Farxiga in Type 1 diabetes. Silon said a decision from European regulators is expected imminently, and the next decision is likely to come from Japanese regulators, followed by the U.S.
"We now have new evidence from Declare-Timi 58 that shows Farxiga consistently reduced hospitalization for heart failure across a broad range of patients with type 2 diabetes, regardless of their history of existing CV disease, including heart attack, or heart failure," said Stephen Wiviott of Brigham and Women's Hospital and Harvard Medical School, a senior investigator with the thrombolysis in myocardial infarction study group and co-principal investigator of the trial.