Influence of model-predicted rivaroxaban exposure and patient characteristics on efficacy and safety outcomes in patients with acute coronary syndrome.


Journal

Therapeutic advances in cardiovascular disease
ISSN: 1753-9455
Titre abrégé: Ther Adv Cardiovasc Dis
Pays: England
ID NLM: 101316343

Informations de publication

Date de publication:
Historique:
entrez: 1 8 2019
pubmed: 1 8 2019
medline: 14 8 2019
Statut: ppublish

Résumé

This analysis aimed to evaluate the impact of rivaroxaban exposure and patient characteristics on efficacy and safety outcomes in patients with acute coronary syndrome (ACS) and to determine whether therapeutic drug monitoring might provide additional information regarding rivaroxaban dose, beyond what patient characteristics provide. A For the incidence of myocardial infarction (MI), ischemic stroke, or nonhemorrhagic cardiovascular death, hazard ratios (HRs) for steady-state maximum plasma concentration (C The shallow slopes of the exposure-response relationships and the lack of a clear therapeutic window render it unlikely that therapeutic drug monitoring in patients with ACS would provide additional information regarding rivaroxaban dose beyond that provided by patient characteristics.

Sections du résumé

BACKGROUND BACKGROUND
This analysis aimed to evaluate the impact of rivaroxaban exposure and patient characteristics on efficacy and safety outcomes in patients with acute coronary syndrome (ACS) and to determine whether therapeutic drug monitoring might provide additional information regarding rivaroxaban dose, beyond what patient characteristics provide.
METHODS METHODS
A
RESULTS RESULTS
For the incidence of myocardial infarction (MI), ischemic stroke, or nonhemorrhagic cardiovascular death, hazard ratios (HRs) for steady-state maximum plasma concentration (C
CONCLUSIONS CONCLUSIONS
The shallow slopes of the exposure-response relationships and the lack of a clear therapeutic window render it unlikely that therapeutic drug monitoring in patients with ACS would provide additional information regarding rivaroxaban dose beyond that provided by patient characteristics.

Identifiants

pubmed: 31364490
doi: 10.1177/1753944719863641
pmc: PMC6669848
doi:

Substances chimiques

Factor Xa Inhibitors 0
Rivaroxaban 9NDF7JZ4M3

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

1753944719863641

Références

Adv Ren Replace Ther. 2000 Jan;7(1):11-21
pubmed: 10672914
JAMA. 2000 Aug 16;284(7):835-42
pubmed: 10938172
Circulation. 2000 Oct 24;102(17):2031-7
pubmed: 11044416
Drug Metab Dispos. 2009 May;37(5):1056-64
pubmed: 19196845
Lancet. 2009 Jul 4;374(9683):29-38
pubmed: 19539361
Am Heart J. 2011 May;161(5):815-821.e6
pubmed: 21570509
N Engl J Med. 2012 Jan 5;366(1):9-19
pubmed: 22077192
Int J Clin Pharmacol Ther. 2013 Jul;51(7):549-61
pubmed: 23458226
Thromb J. 2013 Jul 03;11(1):11
pubmed: 23822763
Clin Pharmacokinet. 2014 Jan;53(1):1-16
pubmed: 23999929
BMJ Open. 2014 Feb 21;4(2):e004425
pubmed: 24561498
Eur J Clin Pharmacol. 2014 Nov;70(11):1339-51
pubmed: 25168620
Lancet. 2015 Jun 6;385(9984):2288-95
pubmed: 25769361
CPT Pharmacometrics Syst Pharmacol. 2016 Apr;5(4):222-32
pubmed: 27299709
CPT Pharmacometrics Syst Pharmacol. 2017 May;6(5):340-349
pubmed: 28547774
CPT Pharmacometrics Syst Pharmacol. 2018 May;7(5):309-320
pubmed: 29660785

Auteurs

Liping Zhang (L)

Global Clinical Pharmacology, Janssen Research and Development, LLC, 5 Pauma Valley Ct, Raritan, NJ 08558, USA.

Xiaoyu Yan (X)

Janssen Research & Development, LLC, Raritan, NJ, USA.

Partha Nandy (P)

Janssen Research & Development, LLC, Raritan, NJ, USA.

Stefan Willmann (S)

Bayer AG, Wuppertal, Germany.

Keith A A Fox (KAA)

Centre for Cardiovascular Sciences, The University of Edinburgh, Edinburgh, UK.

Scott D Berkowitz (SD)

Bayer US LLC, Whippany, NJ, USA.

Amarnath Sharma (A)

Janssen Research & Development, LLC, Raritan, NJ, USA.

Anne Hermanowski-Vosatka (A)

Janssen Research & Development, LLC, Raritan, NJ, USA.

Stephan Schmidt (S)

Department of Pharmaceutics, University of Florida, Orlando, FL, USA.

Jeffrey I Weitz (JI)

McMaster University and the Thrombosis & Atherosclerosis Research Institute, Hamilton, ON, Canada.

Dirk Garmann (D)

Bayer AG, Wuppertal, Germany.

Gary Peters (G)

Janssen Research & Development, LLC, Raritan, NJ, USA.

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Classifications MeSH