The Food and Drug Administration has approved Dapagliflozin to treat heart failure in adult patients with reduced ejection fraction.
Dapagliflozin, produced by UK-Swedish pharmaceutical firm AstraZeneca, is the first and only drug under the sodium glucose transport protein 2 inhibitor (SGLT2i) class approved by the FDA.
It is the only SGLT2i proven to significantly prevent cardiovascular death and death due to other causes in these heart failure patients.
Despite advances in the current treatments, heart failure is still a life-threatening condition with 9 of out 10 patients remainin symptomatic and half of the patients dying within five years of diagnosis.
The FDA approval was based on the landmark trial Dapagliflozin and Prevention of Adverse-outcomes in Heart
Failure Trial. It is the first outcomes trial with an SGLT2 inhibitor investigating the treatment of heart failure with reduced ejection fraction (HFrEF), with and without type-2 diabetes (T2D). The results showed a reduction of 26 percent in the occurrence of cardiovascular death, hospitalization for heart failure, and urgent hospital visit for heart failure.
Dapagliflozin’s significant 18 percent reduction in cardiovascular death and 17 percent reduction in death due to other causes which were only seen in the DAPA HF study.
Dapagliflozin has offered an additional treatment option for patients suffering from the symptoms of heart failure and are at risk of dying given the high mortality rate of the disease.
Safety findings in patients with and without type 2 diabetes were consistent with the well-established safety profile of Dapagliflozin in previous studies. It is consistent regardless of age, gender, severity of heart failure, diabetes status, and kidney function.
“AstraZeneca is committed to uplift the standard of care of Filipino patients by providing them with innovative and accessible treatment. The results from DAPA HF highlight the potential of a novel approach to greatly improve outcomes for patients with HFrEF by slowing disease progression and improving morbidity and mortality. Dapagliflozin has the potential to become a long-awaited addition in the standard of care for this patient population,” said Lotis Ramin, AstraZeneca Philippines country president.
Dr. Orly Bugarin, President of the Philippine Heart Association, added: “The approval of Dapagliflozin for the treatment of heart failure bodes well in the Philippine situation. Despite advances in therapy with heart failure, mortality and morbidity remain high. This signifies that there is still an unmet need for an effective heart failure treatment which Dapagliflozin may address.”
In the Philippines, Dapagliflozin is approved for glycemic control and for the prevention of new or worsening
hospitalization for heart failure or cardiovascular death and nephropathy in adult patients with Type 2 Diabetes.