Traditional and new composite endpoints in heart failure clinical trials: facilitating comprehensive efficacy assessments and improving trial efficiency

Anker, S. D. et al. (2016) Traditional and new composite endpoints in heart failure clinical trials: facilitating comprehensive efficacy assessments and improving trial efficiency. European Journal of Heart Failure, 18(5), pp. 482-489. (doi:10.1002/ejhf.516) (PMID:27071916)

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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.

Item Type:Articles
Additional Information:Correction to this article available at http://dx.doi.org/10.1002/ejhf.591.
Status:Published
Refereed:Yes
Glasgow Author(s) Enlighten ID:McMurray, Professor John and Ford, Professor Ian
Authors: Anker, S. D., Schroeder, S., Atar, D., Bax, J. J., Ceconi, C., Cowie, M. R., Crisp, A., Dominjon, F., Ford, I., Ghofrani, H.-A., Gropper, S., Hindricks, G., Hlatky, M. A., Holcomb, R., Honarpour, N., Jukema, J. W., Kim, A. M., Kunz, M., Lefkowitz, M., Le Floch, C., Landmesser, U., McDonagh, T. A., McMurray, J. J., Merkely, B., Packer, M., Prasad, K., Revkin, J., Rosano, G. M.C., Somaratne, R., Stough, W. G., Voors, A. A., and Ruschitzka, F.
College/School:College of Medical Veterinary and Life Sciences > Institute of Cardiovascular and Medical Sciences
College of Medical Veterinary and Life Sciences > Institute of Health and Wellbeing > Robertson Centre
Journal Name:European Journal of Heart Failure
Publisher:Wiley
ISSN:1388-9842
ISSN (Online):1879-0844
Published Online:12 April 2016
Copyright Holders:Copyright © 2016 The Authors and the European Society of Cardiology
First Published:First published in European Journal of Heart Failure 18(5): 482-489
Publisher Policy:Reproduced in accordance with the publisher copyright policy
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