Entresto® Becomes First FDA-Approved Drug for Heart Failure With Preserved Ejection Fraction (HFpEF)

In February 2021, the U.S. Food and Drug Administration expanded the approval of heart failure with preserved ejection fraction (HFpEF) in adults.1

Entresto overview

The broader use of Entresto will expand the number of people who can take the drug by about two-thirds, to as many as 5 million people. This approval aims to lower the risk of cardiovascular (CV) death and hospitalization for heart failure in adults with chronic heart failure.1

The FDA first approved Entresto in 2015 to treat heart failure with reduced ejection fraction (HFrER) in adults. It is also approved to treat children ages 1 year and older with symptomatic heart failure and systemic left ventricular systolic dysfunction.1,2

What are the ingredients in Entresto?

The active ingredients in Entresto are sacubitril and valsartan.2

How does Entresto work?

The active ingredients in Entresto work together to relax blood vessels so blood can flow more easily. This makes it easier for your heart to pump blood throughout your body.2

Evidence for Entresto

The new approval for Entresto was based on the results of a phase 3 clinical trial. Called the Paragon-HF trial, it included 4,822 people with heart failure with preserved ejection fraction (HFpEF) who were being treated for symptoms. About half of the study participants had a history of hospitalizations from heart failure.1,3

People in the study were randomly assigned to take Entresto (sacubitril/valsartan) or Diovan® (valsartan). The study found that compared to Diovan, Entresto reduced the risk of heart failure hospitalizations and cardiovascular death by 13 percent.1,3

The study also found that Entresto showed the greatest treatment effect in women, as well as people who had been previously hospitalized and were screened during or within 30 days of hospitalization.1,2

Possible side effects

The most common side effects of Entresto include:2

  • Low blood pressure (more common if you also take a water pill)
  • High potassium in the blood
  • Cough
  • Dizziness
  • Kidney problems/kidney failure

Entresto may also cause serious allergic reactions, including swelling of the face, lips, tongue, and throat. These side effects may cause trouble breathing and death. If you experience any side effects that may be life-threatening, contact 911 right away.2

These are not all the possible side effects of Entresto. Talk to your doctor about what to expect or if you experience any changes that concern you during treatment with Entresto.

Things to know about Entresto

Entresto has a boxed warning, the strictest warning from the FDA, because it can harm an unborn baby. Women who become pregnant while taking Entresto should stop taking the drug as soon as possible. Women of childbearing age should talk to their doctor about their treatment options while taking Entresto.2

Entresto may lower blood pressure and kidney function. It may also increase levels of potassium in the blood (hyperkalemia). While taking Entresto, your doctor will monitor your blood pressure, kidney function, and potassium levels.2

Before beginning treatment for heart failure, tell your doctor about all your health conditions and any other drugs, vitamins, or supplements you are taking. This includes over-the-counter drugs.

For more information, read the full prescribing information of Entresto.

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