AstraZeneca receives FDA approval for drug that reduces mort

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


BusinessWorld
February 17, 2021 | 11:44 am
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.”

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