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Individual patient data meta-analysis of beta-blockers in heart failure: rationale and design

Kotecha, Dipak; Manzano, Luis; Altman, Douglas G; Krum, Henry; Erdem, Guliz; Williams, Nicola; Flather, Marcus D; Beta-Blockers in Heart Failure Collaborative Group

Authors

Dipak Kotecha

Luis Manzano

Douglas G Altman

Henry Krum

Guliz Erdem

Nicola Williams

Marcus D Flather

Beta-Blockers in Heart Failure Collaborative Group



Contributors

Alan Rigby
Other

Abstract

The Beta-Blockers in Heart Failure Collaborative Group (BB-HF) was formed to obtain and analyze individual patient data from the major randomized controlled trials of beta-blockers in heart failure. Even though beta-blockers are an established treatment for heart failure, uptake is still sub-optimal. Further, the balance of efficacy and safety remains uncertain for common groups including older persons, women, those with impaired renal function and diabetes. Our aim is to provide clinicians with a thorough and definitive evidence-based assessment of these agents. We have identified 11 large randomized trials of beta-blockers versus placebo in heart failure and plan to meta-analyze the data on an individual patient level. In total, these trials have enrolled 18,630 patients. Uniquely, the BB-HF group has secured access to the individual data for all of these trials, with the participation of key investigators and pharmaceutical companies.Our principal objectives include deriving an overall estimate of efficacy for all-cause mortality and cardiovascular hospitalization. Importantly, we propose a statistically-robust sub-group assessment according to age, gender, diabetes and other key factors; analyses which are only achievable using an individual patient data meta-analysis. Further, we aim to provide an assessment of economic benefit and develop a risk model for the prognosis of patients with chronic heart failure.This paper outlines inclusion criteria, search strategies, outcome measures and planned statistical analyses. Clinical trial registration information: http://clinicaltrials.gov/ct2/show/NCT00832442.

Journal Article Type Article
Publication Date 2013-12
Journal Systematic reviews
Print ISSN 2046-4053
Electronic ISSN 2046-4053
Publisher Springer Verlag
Peer Reviewed Peer Reviewed
Volume 2
Issue 1
Article Number 7
APA6 Citation Kotecha, D., Manzano, L., Altman, D. G., Krum, H., Erdem, G., Williams, N., …Beta-Blockers in Heart Failure Collaborative Group, . (2013). Individual patient data meta-analysis of beta-blockers in heart failure: rationale and design. Systematic reviews, 2(1), https://doi.org/10.1186/2046-4053-2-7
DOI https://doi.org/10.1186/2046-4053-2-7
Keywords Beta-blockers; Heart failure; Meta-analysis; Design paper
Publisher URL https://systematicreviewsjournal.biomedcentral.com/articles/10.1186/2046-4053-2-7
Copyright Statement © Kotecha et al.; licensee BioMed Central Ltd. 2013
This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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Copyright Statement
© Kotecha et al.; licensee BioMed Central Ltd. 2013
This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.





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