After success in a recent clinical trial, dapagliflozin will soon be available to reduce the risk of heart failure in adults with heart failure reduced ejection fraction or preserved ejection fraction.
With the US Food and Drug Administration (FDA) awarding dapagliflozin (Farxiga) their Fast Track designating, investigators spoke in favor of the drug to reduce the risk of heart failure for adults with heart failure with reduced ejection fraction (HFrEF) or preserved ejection fraction (HFpEF).
A pair of successful phase 3 clinical trials--DAPA-HF and DELIVER—revealed the safety in reducing heart failure or cardiovascular death for these patients.
During the Heart Failure Society of America (HFSA) 2019 Scientific Sessions in Philadelphia, PA, John McMurray, MD, University of Glasgow, who was a researcher with the DAPA-HF trial, explained in an interview with MD Magazine® that the success of the trial could yield a bright future for dapagliflozin.
MD Mag: On the goal of the dapagliflozin trial.
McMurray: What we wanted to study in our trial whether these drugs could be used as a treatment for patients with established heart failure. Not only that but we wanted to also ask the question whether these drugs could be beneficial in heart failure patients who do not have diabetes because there is experimental evidence that suggests that SGLT2 inhibitors may have benefits that are not glucose depend. So, to do this, we studied heart failure and reduced ejection fraction receiving conventional therapy who were randomized to either 10 mg of dapagliflozin daily or a placebo
MD Mag: On the results of the dapagliflozin study.
McMurray: For that primary endpoint, we found that dapagliflozin reduced the risk by 26% and that was highly statistically significant. Both of the components of the endpoint were also reduced so there was a 30% reduction in the risk of worsening heart failure events and that was statistically significant and there was an 18% reduction in the risk of cardiovascular mortality and that was also statistically significant.
MD Mag: On the patients self-reporting symptoms during the trial.
McMurray: We had a number of secondary outcomes, but I already just mention 1 of those that's important we also looked at issues self-reported symptoms using the Kansas City Cardiomyopathy Questionnaire and what we find with that questionnaire is
that more people in the dapagliflozin group reported an improvement of symptoms and significantly fewer people in the dapagliflozin group reported a deterioration or worsening of symptoms.
MD Mag: On the future of dapagliflozin.
McMurray: So, in summary what we found was dapagliflozin does what really want any drug to do. It improves symptoms, it improves survival and it reduced hospital admission. It did that in all the important subgroups that we looked at including patients who didn't diabetes, the risk reductions both in relative terms and absolute terms were quite substantial and dapagliflozin was very well tolerated. So, in conclusion we really thought that we've shown that dapagliflozin is a potentially valuable new addition to the drugs that we have treat heart failure with reduced rejection fraction.