FDA: New Option for Chronic Heart Failure

The FDA recently approved ivabradine (Corlanor) to treat chronic heart failure caused by improper contracting of the left-ventricle and to reduce hospitalization.

“Heart failure is a leading cause of death and disability in adults,” said Norman Stockbridge, MD, PhD, director of the Division of Cardiovascular and Renal Products in the FDA’s Center for Drug Evaluation and Research.
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“Corlanor is thought to work by decreasing heart rate and represents the first approved product in this drug class,” he explained. 

Ivabradine is intended for individuals who have stable heart failure symptoms, are taking beta blockers at the highest does they can tolerate, and normal heartbeat with a resting heart rate of at least 70 beats per minute.

The safety and efficacy of ivabradine was determined through a clinical trial of 6505 patients. Compared to a placebo, researchers found that ivabradine decreased the time to initial occurrence of hospitalization for worsening heart failure.

The investigators identified the most common side effects as hypertension, atrial fibrillation, temporary vision disturbances, and bradycardia.

Researchers noted that patients should see their healthcare professional if they experience chest pressure, worsened shortness of breath, dizziness, weakness, fatigue, or irregular heartbeat.

The complete release is published on the US Food and Drug Administration’s website.

-Michelle Canales Butcher

Reference:

The US Food And Drug Administration. FDA approves Corlandor to treat heart failure. April 15, 2015. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm442978.htm. Accessed April 17, 2015.