Download New and Emerging Therapies in the Treatment of Heart Failure

New and Emerging Therapies in the Treatment of Heart Failure
Amanda Guffey, PharmD, BCPS
Providence Hospital
[email protected]
Objectives:
1. Describe safety and efficacy data for novel medications approved for the management
of patients with heart failure
2. Discuss the role of these agents in the treatment of patients with heart failure
Sacubitril/Valsartan (Entresto®):
 Neprilysin inhibitor/angiotensin receptor blocker combination for heart failure with
reduced ejection fraction (HFrEF) approved by FDA in August 2015
 PARADIGM-HF compared sacubitril/valsartan to enalapril in patients with stable HFrEF
(predominantly NYHA Class II) and demonstrated 20% relative risk reduction in both
cardiovascular death and time to first hospitalization for heart failure
 PARAGON-HF trial currently investigating role of sacubitril/valsartan in heart failure with
preserved ejection fraction (HFpEF)
Ivabradine (Corlanor®):
 Selective inhibitor of If channel that decreases heart rate without affecting contractility
 Approved by FDA in April 2015 for patients with HFrEF who have a resting heart rate of
70bpm or higher in sinus rhythm either on maximally tolerated beta blocker therapy or
with contraindication to beta blocker therapy
 SHIFT trial demonstrated significant reduction in time to first HF hospitalization but did
not show significant reduction in cardiovascular mortality
Serelaxin:
 Recombinant form of human relaxin-2 being investigated for management of acute
decompensated heart failure
 FDA rejected approval in March 2014 based on conflicting results of the primary
endpoint (patient reported dyspnea) in the RELAX-AHF trial
 However, FDA granted serelaxin breakthrough status for reduction of cardiovascular
mortality pending RELAX-AHF-2 trial results, which are expected in 2016
Ularitide:
 Synthetic natriuretic peptide being investigated for acute decompensated heart failure
 Phase II trial demonstrated improved dyspnea versus placebo
 Phase III trial TRUE-AHF initiated August 2012 to evaluate mortality and symptoms
References:
1. Kitai T and Tang WW. Recent advances in treatment of heart failure. F1000Research 2015, 4(F1000
Faculty Rev):1475. [http://f1000research.com/articles/4-1475/v1]
2. Hanigan S and DiDomenico RJ. Emerging Therapies for Acute and Chronic Heart Failure. Hope or Hype?
Journal of Pharmacy Practice 2016, Vol 29(1): 46-57. [http://jpp.sagepub.com/content/29/1]