Patients Not Meeting PARADIGM-HF Enrollment Criteria Are Eligible for Sacubitril/Valsartan on the Basis of FDA Approval: The Need to Close the Gap

JACC: Heart Failure

Volumn 5, Issue 6, 2017, Pages 460-463

  Perez, Antonio L ^a   Kittipibul, Veraprapas ^a   Tang, W H Wilson ^a   Starling, Randall C ^a  

^a LERNER RESEARCH INSTITUTE   (United States)

Author keywords

Food and Drug Administration; guidelines; heart failure; heart failure with reduced ejection fraction; sacubitril valsartan

Indexed keywords

ENALAPRIL; POTASSIUM; SACUBITRIL; VALSARTAN; AMINOBUTYRIC ACID DERIVATIVE; ANGIOTENSIN RECEPTOR ANTAGONIST; SACUBITRIL PLUS VALSARTAN; TETRAZOLE DERIVATIVE;

CARDIOVASCULAR MORTALITY; CONFERENCE PAPER; DRUG APPROVAL; DRUG EFFICACY; DRUG INDICATION; DRUG SAFETY; ESTIMATED GLOMERULAR FILTRATION RATE; EVIDENCE BASED MEDICINE; FOOD AND DRUG ADMINISTRATION; HEART FAILURE WITH REDUCED EJECTION FRACTION; HIGH RISK PATIENT; HUMAN; NEW YORK HEART ASSOCIATION CLASS; OUTCOME ASSESSMENT; POTASSIUM BLOOD LEVEL; PRACTICE GUIDELINE; PRIORITY JOURNAL; HEART FAILURE; UNITED STATES;

AMINOBUTYRATES; ANGIOTENSIN RECEPTOR ANTAGONISTS; DRUG APPROVAL; HEART FAILURE; HUMANS; TETRAZOLES; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 85020123153     PISSN: 22131779     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jchf.2017.03.007     Document Type: Conference Paper

References (5)

1. U.S. Food and Drug Administration. FDA News Release: FDA Approves New Drug to Treat Heart Failure. Available at: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm453845.htm. Accessed March 12, 2017.
2. McMurray, J.J., Packer, M., Desai, A.S., et al. Angiotensin-neprilysin inhibition versus enalapril in heart failure. N Engl J Med 371 (2014), 993–1004.
3. Yancy, C.W., Jessup, M., Bozkurt, B., et al. 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: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Failure Society of America. J Am Coll Cardiol 68 (2016), 1476–1488.
4. Perez, A., Kittipibul, V., Tang, W.H., Starling, R., Two-thirds of heart failure patients who meet the FDA-approved indication for sacubitril/valsartan do not meet PARADIGM-enrollment criteria after recent hospitalization. J Am Coll Cardiol, 67(Suppl), 2016, 1546.
5. Packer, M., Love of angiotensin-converting enzyme inhibitors in the time of cholera. J Am Coll Cardiol HF 4 (2016), 403–408.