• J Am Board Fam Med · Jul 2017

    Angioedema Spotlight: A Closer Examination of Sacubitril/Valsartan Safety Results.

    • Ryan E Owens and Carrie S Oliphant.
    • From the Department of Pharmacy, Clinical and Administrative Sciences, University of Oklahoma Health Sciences Center, Oklahoma City (REO); Clinical Pharmacy Specialist, Cardiology/Anticoagulation, Methodist University Hospital, Memphis, TN (CSO); and Department of Clinical Pharmacy, University of Tennessee College of Pharmacy, Nashville (CSO). ryan-owens@ouhsc.edu.
    • J Am Board Fam Med. 2017 Jul 1; 30 (4): 556-557.

    AbstractIncorporation of neprilysin inhibition into heart failure pharmacotherapy regimens has recently been recommended by U.S. guidelines, based on results from the PARADIGM-HF trial comparing sacubitril/valsartan to enalapril. While most of the discussion has focused on efficacy, a closer examination of the safety results, particularly the incidence of angioedema during the run-in and double-blind periods, is also warranted. Although no major safety concerns were identified, an angioedema risk comparable to enalapril was found, primarily in the black population. Therefore, despite combination with an angiotensin receptor blocker, which historically has a lower incidence of angioedema, the addition of neprilysin inhibition yields an angioedema risk profile comparable to angiotensin converting enzyme (ACE) inhibitors. Clinicians should recognize this safety risk when prescribing sacubitril/valsartan and remain vigilant in counseling patients regarding the signs and symptoms of angioedema. As recommended by the guidelines, avoiding sacubitril/valsartan use concurrently or within 36 hours of the last dose of an ACE inhibitor or in patients with a history of angioedema is also crucial to minimize angioedema risk and prevent patient harm.© Copyright 2017 by the American Board of Family Medicine.

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