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New treatment for heart failure approved

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There is a new treatment available for the more than 5 million people who have heart failure in the United States.  It is called ‘Entresto’ and should be available to consumers in the next few weeks.

How does it work and what are the benefits?

In heart failure the heart muscle is weakened and the body activates neurohormaones which does two bad things.  It increases angiotensin II concentrations and reduces bradykinin concentrations.  The use of ACE inhibitors like lisinopril and Angiotensin Receptor Blockers like valsartan have been shown in mega-trials to help patients with heart failure live longer and better but they mostly focus on reducing the bad effects of angiotensin II, not with preserving the good neurohormones.  Entresto has an angiotensin II receptor blocker valsartan in it but it also contains sacubitril.  Sacubitril is in an entirely new class called neprilysin inhibitors that preserves the good neurohormones like bradykinin.

The PARADIGM trial was the gold standard type of trial a randomized, double-blinded comparison of Entresto versus enalapril in 8,442 patients.  At the end of the multiyear study, Entresto had a 20% reduction in the risk of death or hospitalization.  The side effects included low blood pressure, high potassium levels, and a rare but serious reaction called angioedema where people get swelling or the tongue, lips, or face.  Another side effect will be on your wallet.  It costs about $12.50 a day versus less than $1 a day for generic ACE inhibitors.  However, it will likely be covered by private insurance and Medicaid and Medicare because it can prevent hospitalizations which are very expensive.

If a person with heart failure was interested in taking the drug and their doctor agreed, what would their drug regimen look like?

Patients with heart failure should be receiving an ACE inhibitor or Angiotensin Receptor Blocker and a Beta-Blocker.  On top of that, African Americans should receive a combination pill with hydralazine and isosorbide dinitrate while everyone else should receive an aldosterone blocking drug like eplerenone.  If they wanted to receive ENTRESTO, they would substitute their ACE inhibitor or Angiotensin Receptor Blocker for ENTRESTO so the number of drugs they are taking would not change but they will receive some additional benefits by substituting therapy.

Dr. Michael White, Dept. of Pharmacy Practice, UConn School of Pharmacy

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