Analysing recurrent hospitalizations in heart failure: a review of statistical methodology, with application to <scp>CHARM</scp>‐Preserved
-
- Jennifer K. Rogers
- London School of Hygiene and Tropical Medicine London UK
-
- Stuart J. Pocock
- London School of Hygiene and Tropical Medicine London UK
-
- John J.V. McMurray
- University of Glasgow Glasgow UK
-
- Christopher B. Granger
- Duke University Medical Centre Durham USA
-
- Eric L. Michelson
- AstraZeneca Wilmington USA
-
- Jan Östergren
- Karolinska University Hospital Stockholm Sweden
-
- Marc A. Pfeffer
- Brigham and Women's Hospital, Harvard Medical School Boston USA
-
- Scott D. Solomon
- Brigham and Women's Hospital, Harvard Medical School Boston USA
-
- Karl Swedberg
- Sahlgrenska Academy University of Gothenburg Gothenburg Sweden
-
- Salim Yusuf
- Hamilton Health Sciences and McMaster University Hamilton Canada
Description
<jats:sec><jats:title>Aims</jats:title><jats:p>Heart failure is characterized by recurrent hospitalizations, but often only the first event is considered in clinical trial reports. In chronic diseases, such as heart failure, analysing all events gives a more complete picture of treatment benefit. We describe methods of analysing repeat hospitalizations, and illustrate their value in one major trial.</jats:p></jats:sec><jats:sec><jats:title>Methods and results</jats:title><jats:p>The Candesartan in Heart failure Assessment of Reduction in Mortality and morbidity (<jats:styled-content style="fixed-case">CHARM</jats:styled-content>)‐Preserved study compared candesartan with placebo in 3023 patients with heart failure and preserved systolic function. The heart failure hospitalization rates were 12.5 and 8.9 per 100 patient‐years in the placebo and candesartan groups, respectively. The repeat hospitalizations were analysed using the Andersen–Gill, Poisson, and negative binomial methods. Death was incorporated into analyses by treating it as an additional event. The win ratio method and a method that jointly models hospitalizations and mortality were also considered. Using repeat events gave larger treatment benefits than time to first event analysis. The negative binomial method for the composite of recurrent heart failure hospitalizations and cardiovascular death gave a rate ratio of 0.75 [95% confidence interval (<jats:styled-content style="fixed-case">CI</jats:styled-content>) 0.62–0.91, <jats:italic>P</jats:italic> = 0.003], whereas the hazard ratio for time to first heart failure hospitalization or cardiovascular death was 0.86 (95% <jats:styled-content style="fixed-case">CI</jats:styled-content> 0.74–1.00, <jats:italic>P</jats:italic> = 0.050).</jats:p></jats:sec><jats:sec><jats:title>Conclusions</jats:title><jats:p>In patients with preserved <jats:styled-content style="fixed-case">EF</jats:styled-content>, candesartan reduces the rate of admissions for worsening heart failure, to a greater extent than apparent from analysing only first hospitalizations. Recurrent events should be routinely incorporated into the analysis of future clinical trials in heart failure.</jats:p></jats:sec>
Journal
-
- European Journal of Heart Failure
-
European Journal of Heart Failure 16 (1), 33-40, 2013-12-18
Wiley
- Tweet
Details 詳細情報について
-
- CRID
- 1360855569548669952
-
- DOI
- 10.1002/ejhf.29
-
- ISSN
- 18790844
- 13889842
-
- Data Source
-
- Crossref