AstraZeneca receives FDA approval for drug that reduces mortality risk and hospitalization in heart failure patients

Dapagliflozin has been approved by the Food and Drug Administration (FDA) to treat heart failure in adults with reduced ejection fraction (HFrEF) in the Philippines.

The results of the trial showed that dapagliflozin adds to other guideline-recommended therapies in reducing the risk of mortality and heart failure hospitalization. It also improves symptoms in patients with HFrEF.

A total of 4,744 patients 22 to 94 years of age—with a mean age of 66.3 years—were randomized for the trial. The benefit of dapagliflozin was found consistent in both older and younger patients.

“Patients with a history of recurrent urinary tract infection or genital infection should be careful [when taking dapagliflozin],” said Dr. David K. Sim, president of Singapore’s Heart Failure Society, in response to a question about the medication’s contraindications during a February 16 discussion organized by AstraZeneca Philippines. “We also need to remind patients that, if they’re going to have a procedure that requires fasting, they should stop taking the drug prior [to the procedure.]” He added that the effect of the medication on blood pressure is “quite minimal.”

HFrEF, also referred to as systolic heart failure, occurs when the heart muscle does not contract effectively, and therefore pumps out less oxygen-rich blood to the body. Heart failure, commonly called “pumapalyang puso,” occurs when the heart muscle doesn’t pump blood as well as it should. It affects approximately 64 million people worldwide, with half of patients dying within five years of diagnosis.

“Together with the current standard of care, dapagliflozin will contribute further to lower mortality, less heart failure hospitalization and, most importantly, a better quality of life for the patients suffering from heart failure,” said Mr. Sim, adding that Singapore-based doctors have incorporated dapagliflozin in their treatment of HFrEF patients.

“We start new patients on the drug early. We don’t wait six months or one year. Heart failure has a poor prognosis,” he said. “The faster you start the drug, [the better],” he said. Patients reported feeling and sleeping better within a month of taking the medication. Their biomarkers (characteristics of the body you can measure like blood pressure) also showed marked improvement.

Nine million people have heart failure in Southeast Asia, which has an overall 15% mortality rate. In the Philippines, more than one in every five deaths are caused by diseases of the heart, making it the number one leading cause of death, according to the Department of Health.

“To reduce the risk factors of heart failure, one should know what causes it, first of all,” said Dr. Erlyn P. Demerre, the chair of the Heart Failure Program at St. Luke’s Medical Center in Quezon City, at the February 16 event. “Hypertension is the top cause of heart failure.” Other conditions that cause heart failure are coronary artery disease (a disease that develops when the major blood vessels that supply your heart become damaged or diseased), diabetes, and obesity.

Dapagliflozin is also indicated in adults with type two diabetes. Patients with type two diabetes have a more than 2.5-fold greater risk of developing heart failure than patients without diabetes. The prevalence of type two diabetes in patients with chronic heart failure is approximately 30%.

According to the US Food and Drug Administration, the side effects of dapagliflozin oral tablets are as follows: dehydration, serious urinary tract infections, and genital yeast infections. “Patients with kidney problems or low blood pressure are also subject for further medical assessment for their kidney function. Patients with signs and symptoms of metabolic acidosis or ketoacidosis (acid buildup in the blood) should also be assessed. Serious cases of necrotizing fasciitis of the perineum (Fournier’s Gangrene) have been reported in people with diabetes taking [the oral tablets],” the US FDA said in a news release. — Patricia B. Mirasol