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Traditional and new composite endpoints in heart failure clinical trials: Facilitating comprehensive efficacy assessments and improving trial efficiency
Anker, Stefan D. Schroeder, Stefan Atar, Dan Bax, Jeroen J. Ceconi, Claudio Cowie, Martin R. Crisp, Adam Dominjon, Fabienne Ford, Ian Ghofrani, Hossein-Ardeschir
Anker, Stefan D.
Schroeder, Stefan
Atar, Dan
Bax, Jeroen J.
Ceconi, Claudio
Cowie, Martin R.
Crisp, Adam
Dominjon, Fabienne
Ford, Ian
Ghofrani, Hossein-Ardeschir
Author
Anker, Stefan D.
Schroeder, Stefan
Atar, Dan
Bax, Jeroen J.
Ceconi, Claudio
Cowie, Martin R.
Crisp, Adam
Dominjon, Fabienne
Ford, Ian
Ghofrani, Hossein-Ardeschir
Gropper, Savion
Hindricks, Gerhard
Hlatky, Mark A.
Holcomb, Richard
Honarpour, Narimon
Wouter Jukema, J.
Kim, Albert M.
Kunz, Michael
Lefkowitz, Martin P.
Le Floch, Chantal
Landmesser, Ulf
McDonagh, Theresa A.
McMurray, John J. V.
Merkely, Bela
Packer, Milton
Prasad, Krishna
Revkin, James
Rosano, Giuseppe M. C.
Somaratne, Ransi
Stough, Wendy Gattis
Voors, Adriaan A.
Ruschitzka, Frank
Schroeder, Stefan
Atar, Dan
Bax, Jeroen J.
Ceconi, Claudio
Cowie, Martin R.
Crisp, Adam
Dominjon, Fabienne
Ford, Ian
Ghofrani, Hossein-Ardeschir
Gropper, Savion
Hindricks, Gerhard
Hlatky, Mark A.
Holcomb, Richard
Honarpour, Narimon
Wouter Jukema, J.
Kim, Albert M.
Kunz, Michael
Lefkowitz, Martin P.
Le Floch, Chantal
Landmesser, Ulf
McDonagh, Theresa A.
McMurray, John J. V.
Merkely, Bela
Packer, Milton
Prasad, Krishna
Revkin, James
Rosano, Giuseppe M. C.
Somaratne, Ransi
Stough, Wendy Gattis
Voors, Adriaan A.
Ruschitzka, Frank
Abstract
Composite endpoints are commonly used as the primary measure of efficacy in heart failure clinical trials to assess the overall treatment effect and to increase the efficiency of trials. Clinical trials still must enrol large numbers of patients to accrue a sufficient number of outcome events and have adequate power to draw conclusions about the efficacy and safety of new treatments for heart failure. Additionally, the societal and health system perspectives on heart failure have raised interest in ascertaining the effects of therapy on outcomes such as repeat hospitalization and the patient's burden of disease. Thus, novel methods for using composite endpoints in clinical trials ( e.g. clinical status composite endpoints, recurrent event analyses ) are being applied in current and planned trials. Endpoints that measure functional status or reflect the patient experience are important but used cautiously because heart failure treatments may improve function yet have adverse effects on mortality. This paper discusses the use of traditional and new composite endpoints, identifies qualities of robust composites, and outlines opportunities for future research.
Keywords
heart failure, clinical trial, endpoint determination, surrogate endpoints
Date
2016
Type
Journal article
Journal
European Journal of Heart Failure
Book
Volume
18
Issue
5
Page Range
482-489
Article Number
ACU Department
Collections
Relation URI
DOI
Source URL
Event URL
Open Access Status
License
File Access
Controlled