Endpoints in Heart Failure Drug Development: History and Future

Mona Fiuzat*, Naomi Lowy, Norman Stockbridge, Marco Sbolli, Federica Latta, Jo Ann Lindenfeld, Eldrin F. Lewis, William T. Abraham, John Teerlink, Mary Walsh, Paul Heidenreich, Biykem Bozkurt, Randall C. Starling, Scott Solomon, G. Michael Felker, Javed Butler, Clyde Yancy, Lynne W. Stevenson, Christopher O'Connor, Ellis UngerRobert Temple, John McMurray

*Corresponding author for this work

Research output: Contribution to journalReview article

2 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)429-440
Number of pages12
JournalJACC: Heart Failure
Volume8
Issue number6
DOIs
StatePublished - Jun 2020

Keywords

  • FDA
  • clinical trials
  • endpoints
  • heart failure
  • patient-reported outcomes

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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    Fiuzat, M., Lowy, N., Stockbridge, N., Sbolli, M., Latta, F., Lindenfeld, J. A., Lewis, E. F., Abraham, W. T., Teerlink, J., Walsh, M., Heidenreich, P., Bozkurt, B., Starling, R. C., Solomon, S., Felker, G. M., Butler, J., Yancy, C., Stevenson, L. W., O'Connor, C., ... McMurray, J. (2020). Endpoints in Heart Failure Drug Development: History and Future. JACC: Heart Failure, 8(6), 429-440. https://doi.org/10.1016/j.jchf.2019.12.011