#10 Angiotensin-Receptor Neprilysin Inhibitor for Heart Failure

Overview

Heart failure is caused by a weakening of the heart’s ability to pump blood. Between 500,000 and 900,000 new cases of heart failure are diagnosed each year in the United States. This debilitating ailment is now the most common diagnosis in Medicare patients and accounts for 55,000 deaths annually.

Even though great strides have been made in diagnosis and treatment, the prognosis remains poor for people with heart failure. Less than 50 percent of patients are living five years after their initial diagnosis and less than 25 percent are alive at 10 years.

The most common cause of this incapacitating ailment is heart damage due to coronary artery disease or high blood pressure. Fatigue, shortness of breath, fluid retention, and excessive urination at night are common symptoms. Initially, the symptoms are mild, but eventually even slight activity becomes exhausting.

Heart failure is a diagnosis that carries a poor prognosis. Perhaps the most discouraging statistic is that only 25 percent are alive at ten years. Despite these grim figures, the health of patients can be improved and enhanced by medical and device therapy, and in some cases by heart transplantation. Although there is no cure for this chronic and serious condition, heart failure can often be successfully managed.

Talented cardiologists who treat heart failure have more options to offer their patients than ever before. These include a growing array of heart devices and innovative machines that have slowed the natural course of heart failure over the past 20 years. These therapies are not only allowing patients to live longer; their ability to enjoy life with fewer restrictions has also increased.

The consistent use of ACE (angiotensin-converting enzyme) inhibitors, which dilate blood vessels and allow the heart to function more efficiently along with the beta-blockers, which decrease the workload of the heart, has cut the risk of dying from heart failure in half.

However, there is now an experimental heart failure drug that has completely surprised the world of cardiology.

Used in an international study carried out with more than 8,000 patients in 47 countries, the largest ever heart failure study was stopped seven months early because a data review showed that this novel twice-daily drug reduced cardiovascular death rates or hospitalization due to heart failure by 20 percent compared to standard treatment with the ACE inhibitor enalapril, a generic drug that is one of the most widely prescribed treatments. And it also reduced the risk of death due to any cause 16 percent compared with the group taking enalapril.

The investigational drug, called an angiotensin-receptor neprilysin inhibitor, or ARNI, combines sacubitril, a neprilysin inhibitor, with angiotensin receptor blocker (ARB), and it improved outcome in patients who were currently receiving the best possible therapy.

In the study, this drug proved superior to the gold standard ACE inhibitor—and the gold standard dose—for heart failure.

This unique drug compound, which saves lives, reduces long-term health costs, and makes people feel better, may represent not only a major advance in pharmacological treatment but also a completely new paradigm shift in heart failure therapy.

The impressive survival advantage study finding provides strong support for using the new drug instead of ACE inhibitors in the treatment of chronic heart failure. Granted Fast Track status by the Food and Drug Administration, the heart drug is expected to be available in 2015 in the United States.

 

Where Are They Now

This new class of heart failure medication received FDA priority review designation in February 2015, with official approval granted in July.  In studies, the drug was found to reduce risk of cardiovascular death by 20% and HF related hospitalization by 21% when compared to standard treatment. While this treatment option is projected to be more expensive than current standard care, sales are expected to be in the billions by 2019.  Recent analysis has shown that if most, if not all, eligible patients received ARNI therapy, it could possible prevent nearly 28,000 deaths each year in the U.S.

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