| Literature DB >> 32278679 |
Mona Fiuzat1, Naomi Lowy2, Norman Stockbridge2, Marco Sbolli3, Federica Latta3, JoAnn Lindenfeld4, Eldrin F Lewis5, William T Abraham6, John Teerlink7, Mary Walsh8, Paul Heidenreich9, Biykem Bozkurt10, Randall C Starling11, Scott Solomon5, G Michael Felker12, Javed Butler13, Clyde Yancy14, Lynne W Stevenson4, Christopher O'Connor3, Ellis Unger2, Robert Temple2, John McMurray15.
Abstract
Heart failure (HF) patients experience a high burden of symptoms and functional limitations, and morbidity and mortality remain high despite successful therapies. The majority of HF drugs in the United States are approved for reducing hospitalization and mortality, while only a few have indications for improving quality of life, physical function, or symptoms. Patient-reported outcomes that directly measure patient's perception of health status (symptoms, physical function, or quality of life) are potentially approvable endpoints in drug development. This paper summarizes the history of endpoints used for HF drug approvals in the United States and reviews endpoints that measure symptoms, physical function, or quality of life in HF patients.Entities:
Keywords: FDA; clinical trials; endpoints; heart failure; patient-reported outcomes
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Year: 2020 PMID： 32278679 DOI： 10.1016/j.jchf.2019.12.011
Source DB: PubMed Journal: JACC Heart Fail ISSN： 2213-1779 Impact factor: 12.035