Amgen Gets FDA Approval for Corlanor (ivabradine) For Heart Failure | Wing (Bernadette) Cheung, PharmD | RxEconsult
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FDA Approves Corlanor (ivabradine) For Reducing Hospitalization from Heart Failure Category: Heart Disease by - April 22, 2015 | Views: 15304 | Likes: 1 | Comment: 1  

Corlanor (ivrabadine) for heart failure

The FDA approved Amgen's Corlanor (ivabradine) on April 15, 2015. Corlanor is the first heart failure medication approved in nearly over a decade. It was reviewed under the FDA’s priority review program, which provides an expedited review and approval of drugs that are intended to treat  serious diseases or conditions and may provide a significant improvement over available therapy. Corlanor belongs in a new class of medications called  hyperpolarization-activated cyclic nucleotide-gated (HCN) channel. This new drug class provides a viable option for heart failure patients who are still at risk of hospitalization even when receiving maximal doses of standard heart failure therapies. 

Corlanor is indicated for reducing the risk of hospitalization from heart failure in patients with stable, symptomatic chronic heart failure with ventricular ejection fraction <35%, who have a normal heart rhythm with a resting heart rate of >70 beats per minute, and are either on maximum doses of beta-blockers or cannot tolerate beta-blockers.

Heart failure is a chronic heart condition where the heart is unable to pump enough blood to supply the blood and oxygen needed in the body. In 2013, there were 5.1 million people with heart failure in the United States. Heart failure contributed to one in nine deaths in 2009. Half of the people diagnosed with heart failure die within 5 years. In 2010, there were 1 million hospitalizations due to heart failure.

Corlanor works by blocking the hyperpolarization-activated cyclic nucleotide-gated (HCN) channel. HCN channels, also known as pacemaker channels, are responsible for generating and regulating the heart’s firing rate and heart rate. By blocking HCN channels, Corlanor reduces the spontaneous pacemaker activity of the HCN channel, slowing heart rate without affecting the heart’s contractility. With reduced heart rate the heart does not have to work as hard which helps reduce the symptoms of heart failure and frequent hospitalization for worsening heart failure.

In a clinical study involving 6,505 patients Corlanor reduced the risk of hospitalization for worsening heart failure. Hospitalization for worsening heart failure occurred in 15.6% of patients in the Corlanor group compared to 20.2% of patients in the placebo group. Corlanor did not reduce the risk of cardiovascular death which was 8.9% in the Corlanor group versus 8.5% in the placebo group. Most patients (89%) in the study were taking beta-blockers. 

Corlanor is marketed by Amgen and is supplied as 5 and 7.5 mg tablets. The recommended starting dose is 5 mg twice daily. Physicians may adjust the dose according to heart rate after two weeks of treatment and the maximum dose is 7.5 mg twice daily. For patients with a history of conduction defects or patients who may not tolerate a reduced heart rate the recommended starting dose is 2.5 mg twice daily with dose adjustment after two weeks of treatment.

Corlanor should be avoided in patients with:

  • Symptoms of heart failure that recently worsened
  • Blood pressure less than 90/50 mmHg
  • Certain arrhythmias
  • Resting heart rate less than 60 beats per minute
  • Severe liver impairment
  • Pacemaker
  • Medications that may affect blood levels of Corlanor 

Corlanor should not be used in patients with pacemakers set to rates > 60 beats per minute because patients with pacemakers set to this rate will not be able to achieve the Corlanor targeted heart rate of less than 60 beats per minute. 

Corlanor may cause side effects such as reduced heart rate, high blood pressure, atrial fibrillation, and temporary visual disturbance involving flashes of light.

Serious side effects of Corlanor include fetal malformation if used during pregnancy, atrial fibrillation, and slowing of heart rate (bradycardia). Pregnant women should be advised of the potential risk to fetus. Females of reproductive age should use effective birth control and to contact their primary care physician immediately if they become pregnant. Because Corlanor slows heart rate, concomitant use of medications that also slow heart rate should be avoided or monitored carefully. Beta-blockers, digoxin, and amiodarone are examples of drugs that slow heart rate. 

Corlanor is an important new medication for the treatment of heart failure. It has the potential to change the management of heart failure. Hopefully, future studies will show that it can also reduce the risk of death from heart failure or be used for other heart related conditions. 

Also Read

Corlanor (ivabradine) Side Effects, Dosage, Cost, Approval and Prescribing Information for Chronic Heart Failure

LCZ696 and Other Congestive Heart Failure Medications in Development

Guide for Congestive Heart Failure Treatment

 

Nothing Fishy about Fish Oil and Omega-3 Fatty Acids 

References

Corlanor [package insert] Thousand Oaks, CA: Amgen, Inc; April 2015.

Heart Failure Fact Sheet. Centers for Disease Control and Prevention. Centers for Disease Control and Prevention, 3 Dec. 2013. Web. 22 Apr. 2015. 

NCHS Data Brief: Hospitalization for Congestive Heart Failure: United States, 2000-2010."Centers for Disease Control and Prevention. 16 Oct. 2012. Web. 22 Apr. 2015.

US Food and Drug Administration. FDA Approves Corlanor to Treat Heart Failure. 15 Apr. 2015. Web. 22 Apr. 2015. 


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