Amgen’s Corlanor® can help Reduce the Risk of Hospitalization for Patients with worsening Heart Failure
May 4, 2016 by 2012pharmaceutical
Amgen’s Corlanor® can help Reduce the Risk of Hospitalization for Patients with worsening Heart Failure
Reporter: Aviva Lev-Ari, PhD, RN
The hypothetical Heart Failure patients
- Patients with stable, symptomatic chronic heart failure,
- with left ventricular ejection fraction ≤ 35%, who are in
- sinus rhythm with resting heart rate ≥ 70 beats per minute, and either are
- on maximally tolerated doses of beta-blockers or have a contraindication to beta-blocker use
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MAX-TOLERATED BETA-BLOCKER DOSE
Carvedilol 3.125 mg 2x/day(recently reduced to a lower dose)
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REASONS FOR NOT RECEIVING GUIDELINE-RECOMMENDED DOSE
- Hypotension
- Erectile dysfunction
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INDICATION
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Corlanor® (ivabradine) is indicated to reduce the risk of hospitalization for worsening heart failure in patients with stable, symptomatic chronic heart failure with left ventricular ejection fraction ≤ 35%, who are in sinus rhythm with resting heart rate ≥ 70 beats per minute and either are on maximally tolerated doses of beta-blockers or have a contraindication to beta-blocker use.
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IMPORTANT SAFETY INFORMATION
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Contraindications: Corlanor® is contraindicated in patients with acute decompensated heart failure, blood pressure < 90/50 mmHg, sick sinus syndrome, sinoatrial block, 3rd degree atrioventricular block (unless a functioning demand pacemaker is present), a resting heart rate < 60 bpm prior to treatment, severe hepatic impairment, pacemaker dependence (heart rate maintained exclusively by the pacemaker), and concomitant use of strong cytochrome P450 3A4 (CYP3A4) inhibitors.
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Fetal Toxicity: Corlanor® may cause fetal toxicity when administered to a pregnant woman based on embryo-fetal toxicity and cardiac teratogenic effects observed in animal studies. Advise females to use effective contraception when taking Corlanor®.
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Atrial Fibrillation: Corlanor® increases the risk of atrial fibrillation. The rate of atrial fibrillation in patients treated with Corlanor® compared to placebo was 5% vs. 3.9% per patient-year, respectively. Regularly monitor cardiac rhythm. Discontinue Corlanor® if atrial fibrillation develops.
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Bradycardia and Conduction Disturbances: Bradycardia, sinus arrest and heart block have occurred with Corlanor®. The rate of bradycardia in patients treated with Corlanor® compared to placebo was 6% (2.7% symptomatic; 3.4% asymptomatic) vs. 1.3% per patient-year, respectively. Risk factors for bradycardia include sinus node dysfunction, conduction defects, ventricular dyssynchrony, and use of other negative chronotropes. Concurrent use of verapamil or diltiazem also increases Corlanor® exposure, contributes to heart rate lowering, and should be avoided. Avoid use of Corlanor® in patients with 2nd degree atrioventricular block unless a functioning demand pacemaker is present.
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Adverse Reactions: The most common adverse drug reactions reported at least 1% more frequently with Corlanor® than placebo and that occurred in more than 1% of patients treated with Corlanor® were bradycardia (10% vs. 2.2%), hypertension or increased blood pressure (8.9% vs. 7.8%), atrial fibrillation (8.3% vs. 6.6%), and luminous phenomena (phosphenes) or visual brightness (2.8% vs. 0.5%).
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Please see full Prescribing Information and Medication Guide.
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BPM = beats per minute; HF = heart failure; LVEF = left ventricular ejection fraction.
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Reference:
1. Corlanor® (ivabradine) Prescribing Information, Amgen.
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SOURCES
www.amgen.com
From: WebMD Professional Clinical Update <Clinical_Update@mail.webmdprofessional.com>
Reply-To: WebMD Professional <reply-fe9415707d60067476-100_HTML-1821998-7000930-1@mail.webmdprofessional.com>
Date: Wednesday, May 4, 2016 at 8:11 AM
To: Aviva Lev-Ari <AvivaLev-Ari@alum.berkeley.edu>
Subject: Concerned about hospitalization in your patients with chronic HF?
Posted in congestive heart failure, Frontiers in Cardiology and Cardiovascular Disorders, Heart Failure (HF), Origins of Cardiovascular Disease, Pharmacotherapy of Cardiovascular Disease | Tagged left ventricular ejection fraction, sinus rhythm with resting heart rate, stable, symptomatic chronic heart failure, tolerated doses of beta-blockers | Leave a Comment
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