Approved as the first SGLT-2 inhibitor used to treat chronic heart failure
Combined use of Fosci reduces the risk of heart failure and death from cardiovascular disease
AstraZeneca Korea announced that Posiga (ingredient name: dapagliflozin), an SGLT-2 inhibitor-based type 2 diabetes drug, was approved by the Ministry of Food and Drug Safety to add an indication for treatment of chronic heart failure.
According to the additional indications, Posiga can be used for the treatment of chronic heart failure patients 18 years of age or older with reduced left ventricular contractile function. This makes Fociga the first SGLT-2 inhibitor used to treat heart failure with or without diabetes.
Heart failure is a disease in which heart failure cannot supply the amount of blood necessary for metabolism in the body due to decreased heart function. to be. As drugs for improving the survival rate, renin-angiotensin blockers and beta blockers are being used.
The DAPA-HF study was the basis for the addition of the indication for the treatment of heart failure in Posey.
The DAPA-HF study showed that the left ventricular systolic function decreased regardless of the presence or absence of type 2 diabetes (left ventricular ejection rate). [LVEF] 40% or less) A total of 4,744 patients with chronic heart failure (NYHA functional class II~IV) were studied, and about 55% of the total were patients without type 2 diabetes. In addition, more than 94% of all patients took renin-angiotensin blockers, and more than 96% of patients took beta blockers.
As a result of the study, Posiga reduced the risk of death from cardiovascular disease and worsening heart failure, the primary endpoint, by 26% compared to placebo. In addition, the risk of death from all causes and cardiovascular death were both reduced by 17% and 18% compared to placebo, respectively.
In particular, in the group of patients without type 2 diabetes, the risk of deteriorating heart failure and death due to cardiovascular disease was lowered by 27% compared to placebo, confirming that it is effective for heart failure regardless of diabetes. The safety profile of Fociga confirmed in the DAPA-HF study was consistent with the previous studies.
Shim Il, executive director of AstraZeneca Korea’s CVRM Division, said, “We are pleased to be able to provide a new treatment option that can improve the survival rate of patients with heart failure.” “It will be an important starting point for presenting a milestone for SGLT-2 inhibitors that are expanding as treatments for heart failure.”
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