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Posts Tagged ‘sinus rhythm with resting heart rate’


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
  1. MAX-TOLERATED BETA-BLOCKER DOSE

    Carvedilol 3.125 mg 2x/day(recently reduced to a lower dose)

  2.  

    REASONS FOR NOT RECEIVING GUIDELINE-RECOMMENDED DOSE

    • Hypotension
    • Erectile dysfunction

INDICATION

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.

IMPORTANT SAFETY INFORMATION

•  

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.

•  

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®.

•  

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.

•  

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.

•  

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%).

Please see full Prescribing Information and Medication Guide.

BPM = beats per minute; HF = heart failure; LVEF = left ventricular ejection fraction.

Reference:

1. Corlanor® (ivabradine) Prescribing Information, Amgen.

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?

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