Abstract
PARADIGM-HF compared valsartan/sacubitril (ARNI) with enalapril in symptomatic patients with heart failure with reduced ejection fraction (HFrEF) (1). It was stopped early after the boundary for overwhelming benefit in favor of ARNI had been reached. Patients taking ARNI had decreased symptoms, risk of HF hospitalization and all-cause and cardiovascular mortality. We sought to describe our center’s initial year of experience with this novel agent. A retrospective chart review was completed of all patients in our advanced HF clinic who were prescribed ARNI between August 2015 and October 2016. Outcomes data were collected through August 2017. Consistent with the Food and Drug Administration (FDA) indication, patients treated had NYHA class II, III or IV HF symptoms with LVEF of 35% or less. The majority of those prescribed ARNI were able to initiate the medication. However, a significant proportion of patients (26.4%) had to discontinue ARNI due to a variety of reasons, most commonly symptomatic hypotension (31.0%) and insufficient insurance coverage (31.0%). Only 30.5% of patients successfully treated reached the maximum dose; in 85% of these patients, hypotension limited up titration of therapy. PARADIGM-HF demonstrated benefit of ARNI therapy over enalapril in patients with HFrEF and therapy was well tolerated. In our real world experience, hypotension and lack of insurance coverage limited utilization. Further experience with this therapy in a non-trial setting will inform optimal patient selection and titration strategies. Expanded insurance coverage will be crucial to allow for patient access.
Highlights
The goals of heart failure management are to reduce both morbidity by improving overall quality of life and functional status along with mortality
Since the results of the CONSENSUS trial showed a 16% mortality reduction in those with mild to moderate symptoms of heart failure with reduced ejection fraction (HFrEF), angiotensin-converting enzyme (ACE-I) inhibitors have been the cornerstone of treatment [2]
Among patients with HF with reduced ejection fraction, PARADIGM-HF demonstrated a clear benefit of treatment with antagonist/neprilysin inhibitor (ARNI) compared to enalapril
Summary
The goals of heart failure management are to reduce both morbidity by improving overall quality of life and functional status along with mortality. Pharmacologic therapy in HFrEF are to slow or reverse the deterioration in myocardial function due to pathologic remodeling. There have been major strides in management of HFrEF patients that have significantly improved both morbidity and mortality. Since the results of the CONSENSUS trial showed a 16% mortality reduction in those with mild to moderate symptoms of heart failure with reduced ejection fraction (HFrEF), angiotensin-converting enzyme (ACE-I) inhibitors have been the cornerstone of treatment [2]. Further advances in medical therapy were realized when beta blockers, mineralocorticoid receptor antagonists (MRA) and fixed dose hydralazinedinitrate were found to have profound benefits in HFrEF [310]. Cardiac resynchronization therapy (CRT) demonstrated similar benefit [11,12,13]
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