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Verfasst von:Maher, Toby M. [VerfasserIn]   i
 Stowasser, Susanne [VerfasserIn]   i
 Voss, Florian [VerfasserIn]   i
 Bendstrup, Elisabeth [VerfasserIn]   i
 Kreuter, Michael [VerfasserIn]   i
 Martinez, Fernando J. [VerfasserIn]   i
 Sime, Patricia J. [VerfasserIn]   i
 Stock, Christian [VerfasserIn]   i
Titel:Decline in forced vital capacity as a surrogate for mortality in patients with pulmonary fibrosis
Verf.angabe:Toby M. Maher, Susanne Stowasser, Florian Voss, Elisabeth Bendstrup, Michael Kreuter, Fernando J. Martinez, Patricia J. Sime, Christian Stock
Jahr:2023
Umfang:7 S.
Illustrationen:Illustrationen
Fussnoten:Vorab veröffentlicht: 30. August 2023 ; Gesehen am 13.11.2023
Titel Quelle:Enthalten in: Respirology
Ort Quelle:Oxford [u.a.] : Wiley-Blackwell, 1996
Jahr Quelle:2023
Band/Heft Quelle:(2023), Seite 1-7
ISSN Quelle:1440-1843
Abstract:Background and Objective Surrogate endpoints enable determination of meaningful treatment effects more efficiently than applying the endpoint of ultimate interest. We used data from trials of nintedanib in subjects with pulmonary fibrosis to assess decline in forced vital capacity (FVC) as a surrogate for mortality. Methods Data from the nintedanib and placebo groups of trials in subjects with idiopathic pulmonary fibrosis, other forms of progressive pulmonary fibrosis, and pulmonary fibrosis due to systemic sclerosis (NCT00514683, NCT01335464, NCT01335477, NCT01979952, NCT02999178, NCT02597933) were pooled. Using joint models for longitudinal and time-to-event data, we assessed the association between decline in FVC % predicted and time to death over 52 weeks. The rate of change in FVC % predicted and the current value of FVC % predicted were modelled longitudinally and estimates applied as predictors in time-to-event models. Results Among 2583 subjects with pulmonary fibrosis, both a greater rate of decline in FVC % predicted and a lower current value of FVC % predicted were associated with an increased risk of death over 52 weeks (HR 1.79 [95% CI: 1.57, 2.03] and HR 1.24 [1.17, 1.32] per 5-percentage point decrease, respectively). Associations between the rate of change in FVC % predicted and the risk of death were consistent between patients with IPF and other ILDs. Conclusion Data from clinical trials in subjects with pulmonary fibrosis of diverse aetiology demonstrate a strong association between decline in FVC % predicted and mortality over 52 weeks, supporting FVC decline as a surrogate for mortality in these patients.
DOI:doi:10.1111/resp.14579
URL:Bitte beachten Sie: Dies ist ein Bibliographieeintrag. Ein Volltextzugriff für Mitglieder der Universität besteht hier nur, falls für die entsprechende Zeitschrift/den entsprechenden Sammelband ein Abonnement besteht oder es sich um einen OpenAccess-Titel handelt.

kostenfrei: Volltext: https://doi.org/10.1111/resp.14579
 kostenfrei: Volltext: https://onlinelibrary.wiley.com/doi/abs/10.1111/resp.14579
 DOI: https://doi.org/10.1111/resp.14579
Datenträger:Online-Ressource
Sprache:eng
Sach-SW:clinical trial
 interstitial lung disease
 pulmonary function tests
 vital capacity
K10plus-PPN:1870100050
Verknüpfungen:→ Zeitschrift

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