FDA Approved Heart Drug May Decrease Risk of Death by 20%

A new heart-failure drug from the drug maker Novartis, has received FDA approved. The company claims that this drug helps reduce death and hospitalizations from heart failure. A lot of excitement has been building up in regards to this drug, Entresto, since the results of a large clinical trial showed a 20% reduction in the risk of death from cardiovascular disease or hospitalization from a worsening heart failure. 

Novartis has forecasted that Entresto could achieve more than $5 billion in annual sales globally, predicting it to be one of the world's best-selling medications. 

More than 5 million Americans suffer from heart failure, and almost 26 million people worldwide suffer from heart failure where the heart cannot pump enough blood to the body's organs. This oftentimes results in a heart attack or high blood pressure. It can also cause shortness of breath, fatigue, retention of fluids an is one of the leading causes of hospitalizations, if not the leading cause. 

Heart specialists have also predicted that Entresto could replace many existing treatments for chronic heart failure. 

In a clinical trial with more than 8,400 participants, patients were randomly assigned to take either Entresto or enalapril, an ACE inhibitor. Patients in both groups of the study could also take other drugs, such as beta blockers, as their doctors saw fit.

After about 27 months, 21.8 percent of those taking Entresto had either died from cardiovascular causes or had been hospitalized for worsening heart failure, compared with 26.5 percent for those taking enalapril. That represented a relative risk reduction of 20 percent using a measure known as the hazard ratio.

Novartis said that about 2.2 million Americans would be eligible for the drug, which was approved for patients with so-called Class II to Class IV chronic heart failure with so-called reduced ejection fraction. Novartis is sponsoring another study to see if the drug is effective for those with preserved ejection fraction, which accounts for half of heart failure cases.

The FDA said that the main side effects were low blood pressure, high blood potassium levels and kidney impairment. It said there were also cases of angioedema, an allergic reaction that usually results in swelling of the lips or face but can be life threatening if swelling interferes with breathing. Blacks and those with a previous history of the condition were at increased risk, it said.

Entresto is a combination of two drugs, one of which is valsartan, the active ingredient in the blockbuster drug that Novartis sells as Diovan but which now faces generic competition. The other ingredient, sacubitril, inhibits an enzyme known as neprilysin, a new mechanism of action for a heart failure drug.