“The DAPA-HF trial results announced in the recent European Society of Cardiology (ESC) Congress showed that Forxiga met the primary endpoint with a 0.00001 statistical error. This is the first time Forxiga was revealed to be a drug for systolic heart failure.”
Yoo Byung-su, a professor at the Cardiology Department of Wonju Severance Christian Hospital, made the reply to a reporter’s question on clinical implications of the DAPA-HF trial on Forxiga (ingredient: dapagliflozin).
|AstraZeneca’s diabetes treatment Forxiga|
DAPA-HF evaluated the efficacy and safety of Forxiga plus the standard therapy in 4,744 people with heart failure and reduced ejection fraction (HFrEF) whose left ventricular ejection fraction was 40 percent or less.
AstraZeneca unveiled the result of the phase-3 DAPA-HF study on Forxiga in heart failure at ESC Congress 2019 in Paris on Sept. 1. The company released the final data in the New England Journal of Medicine (NEJM) on Thursday.
The data published in NEJM showed that for more than a median of 18.2 months, Forxiga reduced the risk of worsening heart failure or death from cardiovascular causes by 26 percent, compared to the placebo.
A first worsening heart failure event occurred in 237 patients (10 percent) in the Forxiga plus standard therapy group, versus in 326 patients (13.7 percent) in the placebo group. This meant that Forxiga lowered the risk of worsening heart failure by 30 percent. Death from cardiovascular causes occurred in 227 patients (9.6 percent) in the Forxiga group and 273 patients (11.5 percent) in the placebo group. Forxiga reduced the risk of death from cardiovascular causes by 18 percent.
Forxiga also lowered the risk of death from any case by 17 percent, as 276 patients (11.6 percent) in the Forxiga group and 329 patients (13.9 percent) in the placebo group, respectively, died from any cause.
The study results in patients with diabetes were similar to those in patients without it. The frequency of adverse events related to volume depletion, renal dysfunction, and hypoglycemia was not different between treatment groups.
Professor Yoo emphasized that the results of the DAPA-HF trial had significant implications in heart failure treatment.
“Unlike in the oncology field where new drugs are constantly being researched and developed, it is not easy to study new drugs in the cardiovascular disease sector,” Yoo said. “In cancer, we can easily check the therapeutic effect using MRI. But in cardiovascular research, we have to reduce the death rate.”
The DAPA-HF trial clearly showed the birth of a new heart failure treatment, succeeding Entresto (sacubitril/valsartan), he noted.
However, DAPA-HF had limitations in strategies as a therapy, he said.
“The shortcomings of DAPA-HF were that there was a small number of patients who used Entresto in the standard therapy and the study included diabetic patients,” Yoo said.
As Entresto is relatively a new medicine, there is a chance that low-income countries in Europe have not used the drug extensively yet, he added.
Yoo went on to say that when cardiologists treat patients with heart failure, they do not change the method of treatment depending on diabetes. “The dividing of patients with diabetes and those without it could limit the overall use of Forxiga,” he said.
The results of the Forxiga trial have been just released, but other drugmakers will announce the results of studies on other SGLT2 (sodium-glucose cotransporter 2) inhibitors soon, according to Yoo.
“If they also prove similar efficacy or tendencies, SGLT-2 inhibitors’ effect in heart failure will be recognized as the effect of the entire drug class,” he said.