FDA Approves New Heart Failure Medication
Research suggests the new drug helps reduce heart failure-related hospitalizations and deaths due to cardiovascular disease.
A new medication will soon be available to heart failure patients, after a large study of the drug was stopped early in response to better-than-expected results.
The medication is an angiotensin receptor-neprilysin inhibitor known as LCZ696 (Entresto®). The U.S. Food and Drug Administration approved the drug earlier this summer. The drug helps widen arteries to improve blood flow, and, at the same time, helps lower the volume of fluid in the body. Last fall it was on Cleveland Clinic’s Top 10 Innovations for 2015—an annual list of medical breakthroughs expected in the coming year.
“We have kind of been in a stalemate in the treatment of chronic heart failure in the past decade,” says Randall Starling, MD, section head of the Heart Failure Center at Cleveland Clinic. “So to now have a new drug that is well-tolerated and was tested in an 8,000-plus patient trial that reduces all-cause mortality and heart failure (hospital) readmission is a huge things for our patients. It will be widely embraced by caregivers.”
Dr. Starling was the U.S. leader of the PARADIGM trial’s steering committee. PARADIGM was a study of LCZ696 that involved several centers, including Cleveland Clinic. The drug trial was stopped about seven months early because of a significant reduction in death and hospitalizations among patients with heart failure and reduced ejection fraction. Ejection fraction refers to the amount of blood that is pumped from the heart with each heartbeat.
Heart failure is a condition in which the heart has grown weaker and can no longer pump blood as effectively as it once did. Medication combinations and often a variety of cardiac devices and artificial pumps are used to treat heart failure.
One of the most noticeable adverse effects of the new medication is the risk of hypotension, or low blood pressure. Dr. Starling notes that careful blood pressure screenings will have to be done before the new drug can be prescribed. He suggests that if a heart failure patient has done well with a standard dose of an angiotensin-converting enzyme (ACE) inhibitor, a widely used blood pressure-lowering medication, the new drug will probably be well tolerated. “You’ll just want to keep a careful eye on the blood pressure.”
Hypotension can lead to fainting and a higher risk of falls. Other side effects of LCZ696 include a higher risk of hyperkalemia, an imbalance of potassium in the bloodstream. A small percentage of patients also had kidney function complications after taking the drug.
The other key concern now is price. Doctors are waiting to see how the drug will be priced and how insurance payers will cover it. “My hope is that there are no significant financial barriers that impede the ability of patients to have access to this drug,” Dr. Starling says.
Reason for hope
The approval of LCZ696 follows the FDA approval earlier this year of ivabradine (Corlanor®), another heart failure drug. Ivabradine works by slowing the heart rate without adversely affecting the heart muscle itself.
“We’re excited that these new drugs, and others like them, are bringing new options to the treatment of this condition,” says W.H. Wilson Tang, MD, director of Cleveland Clinic’s Center for Clinical Genomics and research director in the Section of Heart Failure.