For patients with stable, symptomatic chronic HF with LVEF 35% and in sinus rhythm with resting heart rate 70 bpm:

Corlanor® significantly reduced the relative risk of hospitalization for worsening HF or CV death by 18%1,2

(Hazard Ratio [95% CI] = 0.82 [0.75 - 0.90]; 4.2% ARR; P < 0.0001)
  • Analysis of time to first event
  • Primary composite endpoint result reflected only a reduction in the risk of hospitalization for worsening HF with no statistically significant benefit on CV death in the overall treatment population

Corlanor® reduced the relative risk of hospitalization for worsening HF1,2

Events at any time

26% reduction 26% reduction

Standard of Care was a clinical regimen that included maximally tolerated doses of beta-blockers and, in most cases, ACE inhibitors or ARBs, spironolactone, and diuretics.

The Systolic Heart failure treatment with the If inhibitor ivabradine Trial (SHIFT) tested the effect of heart rate reduction with Corlanor® in 6,505 patients with chronic HF. Patients received Corlanor® or placebo in addition to SOC, which was a clinical regimen that included maximally tolerated doses of beta-blockers and, in most cases, ACE inhibitors or ARBs, spironolactone, and diuretics.1,2

Study randomization Study randomization

Inclusion criteria1:

  • Optimized and stable treatment for 4 weeks
  • Sinus rhythm with a resting heart rate 70 bpm
  • NYHA class II to IV
  • Reduced LVEF ( 35%)
  • Hospitalization due to worsening heart failure within 12 months

ACE = angiotensin-converting enzyme; ARB = angiotensin II receptor blocker; ARR = absolute risk reduction; BPM = beats per minute; CI = confidence interval; CV = cardiovascular; HF = heart failure; HR = hazard ratio; LVEF = left ventricular ejection fraction; NYHA = New York Heart Association; SOC = standard of care.

References
  1. Corlanor® (ivabradine) Prescribing Information, Amgen.
  2. Swedberg K, Komajda M, Böhm M, et al. Lancet. 2010;376:875-885.
IMPORTANT SAFETY INFORMATION
SEE MORELESS

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. Bradycardia may increase the risk of QT prolongation which may lead to severe ventricular arrhythmias, including torsades de pointes, especially in patients with risk factors such as use of QTc prolonging drugs.

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%).

In postmarketing experience, torsades de pointes has been observed.


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.

back to top
Close