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

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.

View details for DOI 10.1016/j.jchf.2019.12.011

View details for Web of Science ID 000536491400001

View details for PubMedID 32278679