Heart failure is a common and deadly condition in which the heart cannot pump enough blood to meet the body’s needs.

According to the Centers for Disease Control and Prevention (CDC), approximately 6.2 million adults in the United States have heart failure, and the condition contributes to 1 in 8 deaths in the country.

Heart failure has traditionally been managed with medications, lifestyle changes, and in some cases, surgery. However, a new drug has recently been approved by the U.S.

Food and Drug Administration (FDA) that may drastically reduce the mortality rate in heart failure patients.

What is the new drug and how does it work?

The new drug, called sacubitril/valsartan, is a combination of two medications that work together to improve heart function.

Sacubitril is a neprilysin inhibitor, which means it blocks the enzyme neprilysin that breaks down substances that dilate blood vessels and prevent fluid retention. Valsartan, on the other hand, is an angiotensin receptor blocker (ARB) that blocks the effects of a hormone that constricts blood vessels and increases blood pressure.

The combination of sacubitril and valsartan is designed to increase the levels of substances that dilate blood vessels and reduce the levels of substances that constrict blood vessels and retain fluid.

This helps to reduce the workload on the heart and improve its ability to pump blood effectively.

What are the clinical trials saying?

The effectiveness of sacubitril/valsartan has been demonstrated in several clinical trials.

The PARADIGM-HF trial, which involved more than 8,000 heart failure patients with reduced ejection fraction, showed that sacubitril/valsartan reduced the risk of death from cardiovascular causes by 20% compared to standard therapy with an ACE inhibitor. The trial also showed a 16% reduction in the risk of hospitalization for heart failure and an improvement in symptoms and quality of life.

The PIONEER-HF trial, which involved hospitalized heart failure patients with reduced ejection fraction, showed that sacubitril/valsartan reduced the risk of death, hospitalization, and emergency department visits for heart failure by 46% compared to enalapril, an ACE inhibitor.

Who can benefit from sacubitril/valsartan?

Sacubitril/valsartan is indicated for the treatment of heart failure with reduced ejection fraction, which is the type of heart failure in which the heart has difficulty pumping enough blood to the body.

The drug is not recommended for patients with a history of angioedema or who are currently taking ACE inhibitors or aliskiren.

The drug is intended to be used in combination with other heart failure medications, such as beta-blockers, aldosterone antagonists, and diuretics, but not with other ARBs or neprilysin inhibitors.

What are the potential side effects of sacubitril/valsartan?

Like all medications, sacubitril/valsartan has potential side effects. The most common side effects include low blood pressure, kidney problems, high blood potassium levels, and dizziness.

The drug may also increase the risk of angioedema, a serious swelling of the face, lips, tongue, throat, or other body parts, which can be life-threatening.

Patients who experience symptoms of angioedema, such as swelling, difficulty breathing, or hives, should seek immediate medical attention.

Other serious side effects may include hyperkalemia, hypotension, impaired renal function, and symptomatic hypotension.

What is the cost of sacubitril/valsartan?

The cost of sacubitril/valsartan can vary depending on the patient’s insurance coverage and pharmacy. The drug is available in two dosages: 24/26 mg and 49/51 mg, and is taken twice daily.

Patients should talk to their doctor or pharmacist about the cost of the medication and whether it is covered by their insurance.

Conclusion

Sacubitril/valsartan represents a significant advance in the treatment of heart failure with reduced ejection fraction.

The drug has been shown to reduce the risk of death and hospitalization in clinical trials and is recommended by the American College of Cardiology (ACC) and the American Heart Association (AHA) as an alternative to ACE inhibitors or ARBs in patients with heart failure and reduced ejection fraction. However, as with all medications, patients should talk to their doctor about the potential benefits and risks of treatment with sacubitril/valsartan and whether it is right for them.