INDICATIONS

Heart Failure in Adult Patients
Corlanor® is indicated to reduce the risk of hospitalization for worsening heart failure in adult patients with stable, symptomatic chronic heart failure with left ventricular ejection fraction ≤ 35%, who are in sinus rhythm with resting Read More.

Heart Failure in Adult Patients
Corlanor® is indicated to reduce the risk of hospitalization for worsening heart failure in adult 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.

Heart Failure in Pediatric Patients
Corlanor® is indicated for the treatment of stable symptomatic heart failure due to dilated cardiomyopathy [DCM] in pediatric patients aged 6 months and older, who are in sinus rhythm with an elevated heart rate.

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SHIFT Substudy:

Patients treated with Corlanor® in addition to SOC had a significant reduction in heart rate and greater changes in their health-related quality of life (HQoL)

 
1,944
PATIENTS
in a prespecified substudy of the phase 3 trial were analyzed to determine whether reductions in heart rate (HR) with Corlanor® in addition to standard of care (SOC) translate into improved HQoL.1,*
*The primary endpoint was changed in the Kansas City Cardiomyopathy Questionnaire overall summary score (OSS) from baseline to month 12. Other endpoints assessed in the substudy were changes from baseline to the 4-, 12-, and 24-month follow-ups in the OSS and the clinical summary score.

Important considerations:

  • Patients in the main SHIFT study were eligible to participate in the substudy only if their center participated and if the Kansas City Cardiomyopathy Questionnaire (KCCQ) was available in their respective language1
  • 49% of patients in the main SHIFT study had New York Heart Association Class II heart failure, versus 58% in the substudy1
    • The impact of these differences on the findings is not known
 

Patients on Corlanor® in addition to SOC experienced a greater change in KCCQ overall summary score (OSS)1

KCCQ overall summary score (OSS)2
Physical
function
Total symptoms
(frequency and severity)
Social
function
Quality of life
 

A change of 5 units in the KCCQ overall summary score is generally considered to be clinically meaningful.2,3

KCCQ description:2,4

  • A disease-specific self-administered questionnaire to independently measure patients' symptoms and their health status2
  • Scores range from 0 to 100 (higher score = better HQoL)2
  • The KCCQ has been validated by the FDA as a valid, reliable, and responsive health status measure for patients with chronic heart failure (HF)4

Percent of patients with clinically meaningful
improvement in OSS (≥ 5 units) from baseline to month 121,2,*

 
 

Percent of patients with deterioration
in OSS (≥ 5 units) from baseline to month 121,2,*

*Net proportion with 5-unit advantage is calculated by adding the differences in the proportion that improved by at least 5 units on Corlanor® compared with placebo.2

 

Subjects with the greatest HR reduction had improvements in overall summary score.1

LIVE:LIFE Study:

 

The LIVE:LIFE study evaluated the impact of Corlanor® on quality of life in patients ≥ 70 years old

 

Patients saw a reduction in HR and reported changes in multiple dimensions in quality of life5

 

LIVE:LIFE was a multicenter, open-label, prospective observational cohort study assessing HQoL in 240 patients ≥ 70 years with chronic HF following the initiation of Corlanor®. The primary endpoint was change in HQoL total score as measured by the Minnesota Living with Heart Failure Questionnaire (MLWHFQ) after 6 months.5

Important considerations:

  • Open-label, observational, single-arm study
  • Due to absence of control group, it is not possible to evaluate any placebo effect
  • The MLWHFQ has been validated in numerous clinical trials and is recognized by the FDA as a valid, reliable, and responsive health status measure for patients with chronic heart failure.6
 
After 6 months of treatment with Corlanor®, mean heart rate decreased by 12.5 bpm (95% CI, 11 to 14) while HQoL improved by 9 points (95% CI, -6 to 12) compared with baseline.5

A 5-point change in the MLWHFQ is generally
considered to be clinically meaningful.7

Dimensions Evaluated5

 

Minnesota Living with Heart Failure Questionnaire
(MLWHFQ) Results5

 

MLWHFQ description:5,6

  • Disease-specific, 21-item, self-administered questionnaire
  • Patient rates the degree of impact of HF on each of 21 items, ranging from 0 (no effect) to 5 (maximal negative effect)
  • Items are summed for a total score ranging from 0 to 105 (lower scores = better HQoL)
  • The MLWHFQ has been validated by the FDA as a valid, reliable, and responsive health status measure for patients with chronic HF6
 

Patients reported impact on physical and emotional dimensions of the MLWHFQ.5

 

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BPM = beats per minute; CI = confidence interval; FDA = Food and Drug Administration; HR = heart rate; HQoL = health-related quality of life; If = pacemaker/funny curent; n = sample size; SOC = standard of care; SHIFT = Systolic Heart Failure Treatment with the If Inhibitor Ivabradine Trial.

References
  1. Ekman I, Chassany O, Komajda M, et al. Heart rate reduction with ivabradine and health related quality of life in patients with chronic heart failure: Results from the SHIFT study. Eur Heart J. 2011;32:2395-2404.
  2. The Kansas City Cardiomyopathy Questionnaire (KCCQ). https://cvoutcomes.org/pages/3214. Accessed May 20, 2019.
  3. Flynn KE, Ellis SJ, Russell SD, et al. Outcomes, health policy, and managed care: Relationships between patient-reported outcome measures and clinical measures in outpatients with heart failure. Am Heart J. 2009;158(suppl 4):S64-S71.
  4. Medical Device Development Tool (MDDT) qualification decision summary for Kansas City Cardiomyopathy Questionnaire (KCCQ). https://www.fda.gov/media/108301/download. Accessed May 20, 2019.
  5. Zachariah D, Stevens D, Sidorowicz G, et al. Quality of life improvement in older patients with heart failure initiated on ivabradine: Results from the UK multi-centre LIVE:LIFE prospective cohort study. Int J Cardiol. 2017;249:313-316.
  6. Medical Device Development Tool (MDDT) qualification decision summary for Minnesota Living with Heart Failure Questionnnaire (MLHFQ). https://www.fda.gov/media/112157/download. Accessed June 9, 2019.
  7. Arnold M, Rajda M, Ignaszewski A, et al. Changes in the Minnesota Living With Heart Failure Questionnaire score and clinical outcomes in a large contemporary population of ambulatory heart failure patients in the Canadian Heart Failure Network. J Card Fail. 2012;18(suppl):S79.

IMPORTANT SAFETY INFORMATION

Contraindications
Corlanor® is contraindicated in patients with acute decompensated heart failure, clinically significant hypotension, sick sinus syndrome, sinoatrial block, 3rd degree atrioventricular block (unless a functioning demand pacemaker is present), clinically significant bradycardia, 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 of reproductive potential 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

Adult Heart Failure Patients 
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.

Pediatric Heart Failure Patients 
Bradycardia and first-degree heart block were observed in pediatric patients treated with Corlanor®. Asymptomatic and symptomatic bradycardia were observed in 6.8% and 4.1% of pediatric patients treated with Corlanor®, respectively. In the placebo treatment arm, 2.4% of pediatric patients had asymptomatic bradycardia, but none had symptomatic bradycardia. Bradycardia was managed through dose titration but did not result in study drug discontinuation.

Adverse Reactions

Adult Heart Failure Patients 
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.

Pediatric Heart Failure Patients 
Bradycardia (symptomatic and asymptomatic) occurred at rates similar to those in adults. Phosphenes were observed in pediatric patients treated with Corlanor®.

Please see full Prescribing Information and Medication Guide.

INDICATIONS

Heart Failure in Adult Patients 
Corlanor® is indicated to reduce the risk of hospitalization for worsening heart failure in adult 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.

Heart Failure in Pediatric Patients 
Corlanor® is indicated for the treatment of stable symptomatic heart failure due to dilated cardiomyopathy (DCM) in pediatric patients aged 6 months and older, who are in sinus rhythm with an elevated heart rate.

IMPORTANT SAFETY INFORMATION

  • Contraindications: Corlanor® is contraindicated in patients with acute decompensated heart failure, clinically significant hypotension, sick sinus syndrome, sinoatrial block, 3rd degree atrioventricular block (unless a functioning demand pacemaker is present), clinically significant bradycardia, 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