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Utilization of Sacubitril/Valsartan in Real-World Settings

    Basic Details

    Sacubitril/valsartan (SV), an angiotensin-receptor-neprilysin inhibitor (ARNI) and angiotensin-receptor blocker (ARB), was approved on July 7, 2015 for the treatment of patients with New York Heart Association (NYHA) class II–IV heart failure (HF) with reduced ejection fraction (HFrEF). The pivotal trial for new drug approval concluded early because of overwhelming benefts and reported a 20% reduction in death from cardiovascular causes or HF hospitalization compared with enalapril. In 2016, the American College of Cardiology/American Heart Association (ACC/AHA) Task Force on clinical practice guidelines recommended that angiotensin-converting enzyme inhibitors (ACEIs) or ARBs be replaced with an ARNI for patients with chronic symptomatic NYHA class II or III HFrEF to further reduce morbidity or mortality. We examined SV use, duration, and patterns of switching from existing treatments to understand its uptake in the real world.


    Efe Eworuke, Talia J. Menzin, Emily C. Welch, Joy Kolonoski, Ting-Ying Huang

    Corresponding Author

    Efe Eworuke; Division of Epidemiology II, Office of Pharmacovigilance and Epidemiology, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA