New Heart Failure Guidelines
By Darrell Hulisz, RPh,
PhamD and Allison Wetshtein, Pharmacy Intern; Contributors
The American College of
Cardiology (ACC), American Heart Association (AHA), and the Heart Failure
Society of America (HFSA) recently updated the 2013 ACC/AHA guidelines for the
management of heart failure (Yancy, et al., 2016). This update introduces two new pharmacological
agents to the guidelines: Entresto™, which is an angiotensin receptor-neprilysin
inhibitor (ARNI)and Corlanor®, a sinoatrial node modulator
(Yancy, et.al. 2016).
Entresto™ contains the
drug sacubitril, a prodrug that inhibits neprilysin, which causes a decrease in
levels of peptides, including natriuretic peptides, bradykinin, adrenomedullin
and other vasoactive peptides. The primary side effects of Entresto™ include
hypotension, hyperkalemia, and renal insufficiency (Novartis Pharma, 2015). The
drug does carry a small risk of angioedema, and nurses should remind patients
about this potential side effect. While Entresto™ is unlikely to be used in
women of child bearing potential, it is important to know the drug can cause
injury and death to the developing fetus. This drug, as well as other drugs
acting on the renin-angiotensin-aldosterone system should be abruptly
discontinued once pregnancy is confirmed (Novartis Pharma, 2015).
Beta-blockers, angiotensin converting enzyme (ACE) inhibitors, angiotensin
receptor blockers (ARB), and angiotensin receptor neprilysin (ARNI) have all
been shown to decrease morbidity and mortality in heart failure patients
(Solomon, et al., 2016). According to the new guidelines, ARNIs are acceptable
alternatives to ACE inhibitors and ARBs in stable patients with symptomatic
heart failure and a reduced ejection fraction (HFrEF). The guidelines go even
further to state that in patients with chronic symptomatic HFrEF, NYHA class II
or III, who tolerate an ACE inhibitor or ARB, be transitioned to an ARNI to
further reduce the risk of morbidity and mortality (Solomon, et al., 2016).
Before initiation of an
ARNI, patients must first be able to tolerate an ACE inhibitor or ARB (Solomon,
et al., 2016). ACE inhibitors must be stopped 36 hours before ARNIs can be
initiated in patients because any overlap of therapy has been associated with
an increased risk of angioedema and morbidity (Solomon, et al., 2016). Both ACE
inhibitors and ARNI cause the breakdown of bradykinin, which can cause the
adverse event of angioedema. An ARNI should not be administered to anyone who
has a history of angioedema with use of an ACE inhibitor because it may
increase the risk of recurrence of angioedema. The ARNI approved for use in
heart failure based on clinical trials is sacubitril, which is made in a
combination pill with valsartan in a study known as the PARADIGM-HF trial
(Novartis Pharma, 2015). The target dose of valsartan/sacubitril is 97/103 mg
twice daily (Novartis Pharma, 2015).
The second drug included
in the heart failure guideline is Ivabradine, a sinoatrial (SA) node inhibitor,
which slows the firing of the SA node and reduces the heart rate (Amgen Pharma,
2015). It has been demonstrated to decrease heart failure-related
hospitalizations in heart failure patients with left ventricular ejection
fraction (LVEF) of less than 35% (Amgen Pharma, 2015). Ivabradine, however, has
not proven to decrease morbidity or mortality for heart failure patients (Amgen
Pharma, 2015). Ivabradine should only be used in patients already on beta
blockers that have titrated up to the target dose, as tolerated. These patients
must also be in sinus rhythm with a heart rate of 70 bpm or greater (Amgen
Pharma, 2015). Ivabradine should be taken with meals. Adverse reactions include
bradycardia, hypertension, atrial fibrillation, heart block, and sinoatrial
arrest (Amgen Pharma, 2015). This medication is contraindicated in patients
with blood pressure less than90/50mmHg, sick sinus syndrome, third degree heart
block, pacemaker dependence, hepatic impairment, and resting heart rate of less
than 60 beats per minute (Amgen Pharma, 2015).
Recent guidelines issued by the AHA, ACC, and HFSA
introduced two new treatment options for patients experiencing heart failure. These
guidelines offer nurses evidence-based recommendations that will enable them to
make informed decisions when prescribing, administering and monitoring patients
taking these new medications.
Brush up on you knowledge of heart failure by taking the
following courses from Rn.com: Diagnosis and Management of Heart Failure and Heart
Failure Review and Medication Strategies for APRNs.
Amgen Pharma. (2015). Corlanor®: Highlights of prescribing
information. Thousand Oaks, Ca. Retrieved
Novartis Pharma. (2015).
Entresto™: Highlights of prescribing information. New Jersey. Retrieved from:https://www.pharma.us.novartis.com/sites/www.pharma.us.novartis.com/files/entresto.pdf
Solomon, S.D., Claggett, B., Desai, A.S., Packer,
M., Zile, M., Swedberg, K. …McCurray, J.J. (2016). Influence of ejection fraction on outcomes and efficacy
of sacubitril/valsartan (LCZ696) in heart failure with reduced ejection
fraction: The prospective comparison of ARNI with ACEI to determine impact on global
mortality and morbidity in heart failure (PARADIGM-HF) trial. Circulation 9 (3). doi:10.1161/CIRCHEARTFAILURE.115.002744.
Yancy, C.W., Jessup, M.,
Bozkurt, B., Butler, J., Casey, D.E., Colvin, M.M. … Westlake, C. (2016). 2016 ACC/AHA/HFSA Focused update on new pharmacological
therapy for heart failure: An update of the 2013 ACCF/AHA guideline for the management
of heart failure. Circulation 135 (2).