Novartis' new heart failure medicine LCZ696, now called Entresto(TM), approved by FDA to reduce risk of cardiovascular death and heart failure hospitalization
A new drug for congestive heart failure was fast-tracked by the Food and Drug Administration because it works so well. The results of Phase III Clinical trials prompted officials to give approval for marketing Entresto.
Cardiophysiology of Congestive Heart Failure
What Is Heart Failure?
What Causes Heart Failure?
- Coronary artery disease. Coronary artery disease (CAD), a disease of the arteries that supply blood and oxygen to the heart, causes decreased blood flow to the heart muscle. If the arteries become blocked or severely narrowed, the heart becomes starved for oxygen and nutrients.
- Heart attack. A heart attack occurs when a coronary artery becomes suddenly blocked, stopping the flow of blood to the heart muscle. A heart attack damages the heart muscle, resulting in a scarred area that does not function properly.
- Cardiomyopathy. Damage to the heart muscle from causes other than artery or blood flow problems, such as from infections or alcohol or drug abuse.
- Conditions that overwork the heart. Conditions including high blood pressure, valve disease, thyroid disease, kidney disease,diabetes, or heart defects present at birth can all cause heart failure. In addition, heart failure can occur when several diseases or conditions are present at once.
What Are the Symptoms of Heart Failure?
- Congested lungs. Fluid backup in the lungs can cause shortness of breath with exercise or difficulty breathing at rest or when lying flat in bed. Lung congestion can also cause a dry, hacking coughor wheezing.
- Fluid and water retention. Less blood to your kidneys causes fluid and water retention, resulting in swollen ankles, legs,abdomen (called edema), andweight gain. Symptoms may cause an increased need to urinate during the night. Bloatingin your stomach may cause a loss of appetite or nausea.
- Dizziness, fatigue, andweakness. Less blood to your major organs and muscles makes you feel tired and weak. Less blood to the brain can cause dizziness or confusion.
- Rapid or irregular heartbeats.The heart beats faster to pump enough blood to the body. This can cause a rapid or irregular heartbeat.
What Are the Types of Heart Failure?
How Is Heart Failure Diagnosed?
- Blood tests. Blood tests are used to evaluate kidney and thyroidfunction as well as to checkcholesterol levels and the presence of anemia. Anemia is a blood condition that occurs when there is not enoughhemoglobin (the substance in red blood cells that enables the blood to transport oxygen through the body) in a person's blood.
- B-type Natriuretic Peptide (BNP) blood test. BNP is a substance secreted from the heart in response to changes inblood pressure that occur when heart failure develops or worsens. BNP blood levels increase when heart failure symptoms worsen, and decrease when the heart failure condition is stable. The BNP level in a person with heart failure -- even someone whose condition is stable -- is higher than in a person with normal heart function. BNP levels do not necessarily correlate with the severity of heart failure.
- Chest X-ray. A chest X-ray shows the size of your heart and whether there is fluid build-up around the heart and lungs.
- Echocardiogram. This test is an ultrasound which shows the heart's movement, structure, and function.
- The Ejection Fraction (EF) is used to measure how well your heart pumps with each beat to determine if systolic dysfunction or heart failure with preserved left ventricular function is present. Your doctor can discuss which condition is present in your heart.
- Electrocardiogram (EKG or ECG) . An EKG records the electrical impulses traveling through the heart.
- Cardiac catheterization. This invasive procedure helps determine whether coronary artery disease is a cause of congestive heart failure.
- Stress Test. Noninvasive stress tests provide information about the likelihood of coronary artery disease.
Is There a Treatment for Heart Failure?
Treatment can begin with simple health and wellness advice.
Definition of Stage
|People at high risk of developing heart failure (pre-heart failure), including people with:||Exercise regularly.|
People diagnosed with systolic left ventricular dysfunction but who have never had symptoms of heart failure (pre-heart failure), including people with:
The diagnosis is usually made when an ejection fraction of less than 40% is found during an echocardiogram test.
If appropriate, surgery options should be discussed for patients who have had a heart attack.
Patients with known systolic heart failure and current or prior symptoms. Most common symptoms include:
Patients with systolic heart failure and presence of advanced symptoms after receiving optimum medical care.
Treatment is progressive and adjusted accordingly. Heart failure is chronic and may be progressive. It can present abruptly from an acute coronary obstruction, or insidiously with aging.
ENTRESTO is not a first line drug and is intended for refractory CHF. It is very expensive.
Could remote monitoring help Novartis persuade payers to reimburse for new heart drug?
Morning Read: Could remote monitoring help Novartis persuade payers to reimburse for new heart drug?MedCity News