October 02, 2015 – Recently, the American Food and Drug Administration (FDA) approved Sacubitril/Valsartan (Entresto) for the treatment of heart failure. Similarly, a few days ago, the European Medicines Agency (EMA) recommended granting a marketing authorisation for Sacubitril/Valsartan (Entresto) for the treatment of adults with symptomatic chronic heart failure with reduced ejection fraction, a condition where the heart muscle does not contract effectively and less oxygen-rich blood is pumped out to the body. Around half of people with heart failure will have reduced ejection fraction.
Heart failure is a common and serious condition often caused by coronary artery disease (when the blood vessels supplying the heart become narrow), a heart attack or high blood pressure. Heart failure generally worsens over time. Although currently recommended treatments have improved the prognosis for people with heart failure, it remains alife-threatening disease which results in frequent hospital visits, and seriously impairs a patient’s ability to enjoy an active life. In the US alone, heart failure affects about 5.1 million people and is a leading cause of death and disability in adults, according to Norman Stockbridge, M.D., Ph.D., director of the Division of Cardiovascular and Renal Products in the FDA’s Center for Drug Evaluation and Research.
Entresto is a combination of Valsartan (an angiotensin II receptor blocker (ARB)) and Sacubitril. Sacubitril is the first in a new class of medicines called neprilysin inhibitors. Entresto works in two ways: Valsartan blocks the angiotensin II type-1 receptor, suppressing the harmful effects of angiotensin II on the cardiovascular system while Sacubitril blocks an enzyme known as neprilysin to enhance the protective neurohormonal systems of the heart. Because of its mechanism of action Entresto should not be given together with another ARB or with an ACE inhibitor.
Sacubitril/Valsartan (Entresto) was studied in a clinical trial of more than 8,000 adults and was shown to reduce the rate of cardiovascular death and hospitalizations related to heart failure compared to another drug, enalapril. Patients also received other heart failure medicines. Patients were included in the trial if they were able to tolerate treatment with Entresto, i.e. they did not need to stop treatment with Entresto due to side effects during a run-in period before the start of the trial. The trial was stopped early when it was found that Sacubitril/Valsartan (Entresto) was more effective than enalapril in reducing deaths from cardiovascular disease. The patients were followed for a median of 27 months. During the follow-up period 13.3% of the patients treated with Sacubitril/Valsartan (Entresto) died from cardiovascular disease compared with 16.5% of the patients treated with enalapril. The trial also found that Sacubitril/Valsartan (Entresto) reduced the number of patients who had to be hospitalised for heart failure.
Patient of African American descent suffering from angioedema
The most common side effects in clinical trial participants being treated with Sacubitril/Valsartan (Entresto) were low blood pressure (hypotension), high blood potassium levels (hyperkalemia), and poor function of the kidneys (renal impairment). Angioedema (an allergic reaction usually appearing as swelling of the lips or face) was also reported with Sacubitril/Valsartan (Entresto); apparently, patients with African American descent and patients with a prior history of angioedema have a higher risk. Patients should be advised to get emergency medical help right away if they have symptoms of angioedema or trouble breathing while on Sacubitril/Valsartan (Entresto).
Health care professionals should advise patients not to use Sacubitril/Valsartan (Entresto) with any drug from the angiotensin converting enzyme (ACE) inhibitor class because the risk of angioedema is increased. When switching between Sacubitril/Valsartan (Entresto) and an ACE inhibitor, use of the two drugs should be separated by 36 hours. Health care professionals should counsel patients about the risk of harm to an unborn baby. If pregnancy is detected, use of Sacubitril/Valsartan (Entresto) should be discontinued as soon as possible.
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