Media Statement: Leading US cardiology societies strongly recommend Entresto® as a new standard of care treatment in an earlier-than-expected joint update of clinical practice guidelines for heart failure
May 20, 2016
Three leading US cardiology societies have jointly issued a clinical practice guideline update that has redefined standard of care treatment for heart failure and given Entresto® a strong Class I Level of Evidence B-R recommendation for the management of heart failure with reduced ejection fraction (HFrEF).1 The earlier-than-expected update was released simultaneously with new European guidance.1,2
Entresto is now a guideline-recommended standard therapy for chronic HFrEF patients to reduce morbidity and mortality, as an alternative to angiotensin converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARB), together with a beta blocker and an aldosterone antagonist.1 To further reduce morbidity and mortality, the guideline specifically advises doctors to switch chronic HFrEF patients with mild to moderate symptoms who are otherwise tolerating an ACE or ARB to Entresto.1 Class I is the strongest type of recommendation recognizing the benefits of a treatment, and level B-R is the highest possible quality of clinical evidence for a treatment with only a single randomized clinical trial.1
Jointly issued by the American College of Cardiology (ACC), the American Heart Association (AHA) and the Heart Failure Society of America (HFSA), the new guideline underscores the potential of Entresto to significantly reduce risk of death due to cardiovascular causes or heart failure hospitalization, and the critical need to reduce the impact of this devastating disease on patients and our healthcare system.1 This is excellent news for physicians and patients with HFrEF. Heart failure is a debilitating condition that affects nearly 6 million people in the US, about half of whom have the reduced ejection fraction form.3,4
Heart failure patients may suffer poor quality of life and are at increased risk of hospitalization and death.3,5,6,7 Not only do heart failure patients suffer from symptoms that may impact their daily lives, about half of patients diagnosed with heart failure die within 5 years.3,8,9 Symptoms of HF can include shortness of breath, swollen limbs due to build-up of fluid, and fatigue.10
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about ENTRESTO?
ENTRESTO can harm or cause death to your unborn baby. Talk to your doctor about other ways to treat heart failure if you plan to become pregnant. If you get pregnant while taking ENTRESTO, tell your doctor right away.
What is ENTRESTO?
ENTRESTO is a prescription medicine used to reduce the risk of death and hospitalization in people with certain types of long-lasting (chronic) heart failure. ENTRESTO is usually used with other heart failure therapies, in place of an ACE inhibitor or other ARB therapy.
Who should not take ENTRESTO?
Do not take ENTRESTO if you:
are allergic to sacubitril or valsartan or any of the ingredients in ENTRESTO
have had an allergic reaction including swelling of your face, lips, tongue, throat (angioedema) or trouble breathing while taking a type of medicine called an angiotensin-converting enzyme (ACE) inhibitor or angiotensin II receptor blocker (ARB)
take an ACE inhibitor medicine. Do not take ENTRESTO for at least 36 hours before or after you take an ACE inhibitor medicine. Talk with your doctor or pharmacist before taking ENTRESTO if you are not sure if you take an ACE inhibitor medicine
have diabetes and take a medicine that contains aliskiren
What should I tell my doctor before taking ENTRESTO?
Before you take ENTRESTO, tell your doctor about all of your medical conditions, including if you have kidney or liver problems; are pregnant or plan to become pregnant; are breastfeeding or plan to breastfeed. You should either take ENTRESTO or breastfeed. You should not do both.
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your doctor if you take potassium supplements or a salt substitute; nonsteroidal anti-inflammatory drugs (NSAIDs); lithium; or other medicines for high blood pressure or heart problems such as an ACE inhibitor, ARB, or aliskiren.
What are the possible side effects of ENTRESTO?
ENTRESTO may cause serious side effects including:
angioedema that may cause trouble breathing and death. Get emergency medical help right away if you have symptoms of angioedema or trouble breathing. Do not take ENTRESTO again if you have had angioedema while taking ENTRESTO. People who are Black or who have had angioedema and take ENTRESTO may have a higher risk of having angioedema
low blood pressure (hypotension). Call your doctor if you become dizzy or lightheaded, or you develop extreme fatigue
increased amount of potassium in your blood
The most common side effects were low blood pressure, high potassium, cough, dizziness, and kidney problems.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.