NT-proBNP Qualifies as a Surrogate for Clinical End Points in Heart Failure.


Journal

Clinical pharmacology and therapeutics
ISSN: 1532-6535
Titre abrégé: Clin Pharmacol Ther
Pays: United States
ID NLM: 0372741

Informations de publication

Date de publication:
08 2021
Historique:
received: 08 09 2020
accepted: 27 01 2021
pubmed: 26 2 2021
medline: 28 8 2021
entrez: 25 2 2021
Statut: ppublish

Résumé

N-terminal pro-B-type natriuretic peptide (NT-proBNP) is a well-established biomarker in heart failure (HF) but controversially discussed as a potential surrogate marker in HF trials. We analyzed the NT-proBNP/mortality relationship in real-world data (RWD) of 108,330 HF patients from the IBM Watson Health Explorys database and compared it with the NT-proBNP / clinical event end-point relationship in 20 clinical HF studies. With a hierarchical statistical model, we quantified the functional relationship and interstudy variability. To independently qualify the model, we predicted outcome hazard ratios in five phase III HF studies solely based on NT-proBNP measured early in the respective study. In RWD and clinical studies, the relationship between NT-proBNP and clinical outcome is well described by an E

Identifiants

pubmed: 33630302
doi: 10.1002/cpt.2222
pmc: PMC8360001
doi:

Substances chimiques

Biomarkers 0
Peptide Fragments 0
pro-brain natriuretic peptide (1-76) 0
Natriuretic Peptide, Brain 114471-18-0

Types de publication

Journal Article Meta-Analysis

Langues

eng

Sous-ensembles de citation

IM

Pagination

498-507

Informations de copyright

© 2021 Bayer AG. Clinical Pharmacology & Therapeutics published by Wiley Periodicals LLC on behalf of American Society for Clinical Pharmacology and Therapeutics.

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Auteurs

Walter Schmitt (W)

Pharmacometrics, Bayer AG - Pharmaceuticals, Wuppertal, Germany.

Hauke Rühs (H)

Quantitative Pharmacology, Bayer AG - Pharmaceuticals, Wuppertal, Germany.

Rolf Burghaus (R)

Systems Pharmacology & Medicine, Bayer AG - Pharmaceuticals, Wuppertal, Germany.

Christian Diedrich (C)

Systems Pharmacology & Medicine, Bayer AG - Pharmaceuticals, Wuppertal, Germany.

Sulav Duwal (S)

Systems Pharmacology & Medicine, Bayer AG - Pharmaceuticals, Wuppertal, Germany.

Thomas Eissing (T)

Pharmacometrics, Bayer AG - Pharmaceuticals, Wuppertal, Germany.

Dirk Garmann (D)

Quantitative Pharmacology, Bayer AG - Pharmaceuticals, Wuppertal, Germany.

Michaela Meyer (M)

Pharmacometrics, Bayer AG - Pharmaceuticals, Wuppertal, Germany.

Bart Ploeger (B)

Pharmacometrics, Bayer AG - Pharmaceuticals, Wuppertal, Germany.

Jörg Lippert (J)

Pharmacometrics, Bayer AG - Pharmaceuticals, Wuppertal, Germany.

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Classifications MeSH