-Posiga approved as the first SGLT-2 inhibitor used to treat chronic heart failure with reduced left ventricular contractile function
-Results of the DAPA-HF study show that the combination of Fosci can worsen heart failure and reduce the risk of death from cardiovascular disease.
AstraZeneca Korea (CEO Sang-pyo Kim)’s SGLT-2 inhibitor type 2 diabetes drug Posiga (ingredient name: dapagliflozin) was approved by the Ministry of Food and Drug Safety to add an indication to treat chronic heart failure on December 22nd.
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.[1] This makes Focigar the first SGLT-2 inhibitor to be used as a treatment for heart failure with or without diabetes.
Heart failure is a disease in which the body cannot supply the necessary amount of blood for metabolism due to decreased heart function.[2] The goals of heart failure treatment are ▲improving the clinical condition of heart failure patients, ▲improving the range of functions and quality of life of the patient, ▲preventing hospitalization and reducing mortality.[3] As drugs for improving the survival rate, renin-angiotensin blockers and beta blockers are being used.3
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 patients were taking renin-angiotensin blockers, and more than 96% of patients were taking beta blockers.[4]
According to the results of the DAPA-HF study, Posiga reduced the risk of exacerbation of heart failure and death from cardiovascular disease, 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.4 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.4 The safety profile of Fociga confirmed in the DAPA-HF study was consistent with the previous studies.4
Il Shim, Managing Director of CVRM Division of AstraZeneca Korea, said, “We are pleased to be able to provide a new treatment option for Posiga to improve the survival rate of patients with heart failure.” Furthermore, it will be an important starting point for presenting a milestone for SGLT-2 inhibitors that are expanding as treatments for heart failure.”
References
[1] Ministry of Food and Drug Safety. Drug Safety Nara (Integrated Drug Information System)-Other. Posey family.
[2] Park Jin-ju, Choi Dong-ju. Left ventricular contractile hypofunction Treatment of heart failure. Korean Journal of Medicine, 88.2 (2015): 127-134.
[3] The Korean Society of Heart Failure: The Reality of Drug and Device Treatment for Heart Failure Patients (2020)
[4] John JV McMurray, et al. Dapagliflozin in Patients with Heart Failure and Reduced Ejection Fraction. N Engl J Med. 2019 Nov 21;381(21):1995-2008 DOI: 10.1056/NEJMoa1911303