Apixaban and rivaroxaban in obese patients treated for venous thromboembolism: Drug levels and clinical outcomes.


Journal

Thrombosis research
ISSN: 1879-2472
Titre abrégé: Thromb Res
Pays: United States
ID NLM: 0326377

Informations de publication

Date de publication:
Dec 2021
Historique:
received: 20 07 2021
revised: 24 09 2021
accepted: 12 10 2021
pubmed: 25 10 2021
medline: 24 12 2021
entrez: 24 10 2021
Statut: ppublish

Résumé

Direct oral anticoagulants (DOAC) use remains challenging in obese patients treated for Venous-Thrombo-Embolism (VTE) due to the paucity of prospective and dedicated studies. To assess rivaroxaban and apixaban concentrations at different time-points after intake, in obese patients followed at a thrombosis center and treated for VTE; to define factors associated with DOAC levels outside the on-therapy ranges; and to evaluate bleeding and thrombosis rates during follow-up. Observational prospective study in two French University hospitals. Apixaban or rivaroxaban concentrations were measured after the first visit, regardless of last intake in obese patients receiving DOAC for VTE. Concentrations were compared to published reference values for non-obese patients. Demographic, clinical, biological and therapeutic data were collected. Univariate and multivariate analyses were performed to identify factors associated to DOAC concentrations outside the on-therapy ranges. Out of the 146 patients included, 22 (15%) had DOAC concentrations outside the on-therapy ranges, mainly in the rivaroxaban group (n = 17). Age ≤ 63 years, use of rivaroxaban and time since last intake ≤8 h were associated with DOAC concentrations outside the on-therapy ranges, in multivariable analysis. During the median follow-up of 16 months, two (1%) patients receiving apixaban had recurrent VTE. No patient had major bleeding, 11 (8%) patients had minor bleeding. In this specific prospective bi-centric study dedicated to VTE obese patients, use of DOACs at fixed doses led to concentrations similar to those of non-obese patients in a high proportion of patients, without any effect of the BMI, and with risk-benefit profile comparable to non-obese patients.

Sections du résumé

BACKGROUND BACKGROUND
Direct oral anticoagulants (DOAC) use remains challenging in obese patients treated for Venous-Thrombo-Embolism (VTE) due to the paucity of prospective and dedicated studies.
OBJECTIVE OBJECTIVE
To assess rivaroxaban and apixaban concentrations at different time-points after intake, in obese patients followed at a thrombosis center and treated for VTE; to define factors associated with DOAC levels outside the on-therapy ranges; and to evaluate bleeding and thrombosis rates during follow-up.
METHODS METHODS
Observational prospective study in two French University hospitals. Apixaban or rivaroxaban concentrations were measured after the first visit, regardless of last intake in obese patients receiving DOAC for VTE. Concentrations were compared to published reference values for non-obese patients. Demographic, clinical, biological and therapeutic data were collected. Univariate and multivariate analyses were performed to identify factors associated to DOAC concentrations outside the on-therapy ranges.
RESULTS RESULTS
Out of the 146 patients included, 22 (15%) had DOAC concentrations outside the on-therapy ranges, mainly in the rivaroxaban group (n = 17). Age ≤ 63 years, use of rivaroxaban and time since last intake ≤8 h were associated with DOAC concentrations outside the on-therapy ranges, in multivariable analysis. During the median follow-up of 16 months, two (1%) patients receiving apixaban had recurrent VTE. No patient had major bleeding, 11 (8%) patients had minor bleeding.
CONCLUSION CONCLUSIONS
In this specific prospective bi-centric study dedicated to VTE obese patients, use of DOACs at fixed doses led to concentrations similar to those of non-obese patients in a high proportion of patients, without any effect of the BMI, and with risk-benefit profile comparable to non-obese patients.

Identifiants

pubmed: 34689080
pii: S0049-3848(21)00483-7
doi: 10.1016/j.thromres.2021.10.009
pii:
doi:

Substances chimiques

Pharmaceutical Preparations 0
Pyrazoles 0
Pyridones 0
apixaban 3Z9Y7UWC1J
Rivaroxaban 9NDF7JZ4M3

Types de publication

Journal Article Observational Study

Langues

eng

Sous-ensembles de citation

IM

Pagination

39-44

Informations de copyright

Copyright © 2021 Elsevier Ltd. All rights reserved.

Auteurs

Alice Ballerie (A)

Department of Internal Medicine and Clinical Immunology, Rennes University Hospital, Rennes, France; Univ Rennes, Rennes University Hospital, Inserm, EHESP, Irset (Institut de Recherche en Santé, Environnement et Travail) - UMR_S 1085, Rennes, France.

Rémi Nguyen Van (R)

Department of Internal Medicine and Clinical Immunology, Rennes University Hospital, Rennes, France.

Karine Lacut (K)

Department of Internal Medecine and Chest Diseases, Brest University Hospital, Bretagne Occidentale University, EA 3878, CIC INSERM 1412, Brest, FCRIN INNOVTE, France.

Hubert Galinat (H)

Hematology Laboratory, Brest University Hospital, Bretagne Occidentale University, EA 3878, Brest, France.

Chloé Rousseau (C)

Clinical Investigation Center INSERM 1414, Department of Clinical Pharmacology, Rennes University Hospital, F-35033, France.

Adeline Pontis (A)

Hematology Laboratory, Rennes University Hospital, Rennes, France.

Fabienne Nédelec-Gac (F)

Hematology Laboratory, Rennes University Hospital, Rennes, France.

Alain Lescoat (A)

Department of Internal Medicine and Clinical Immunology, Rennes University Hospital, Rennes, France; Univ Rennes, Rennes University Hospital, Inserm, EHESP, Irset (Institut de Recherche en Santé, Environnement et Travail) - UMR_S 1085, Rennes, France.

Nicolas Belhomme (N)

Department of Internal Medicine and Clinical Immunology, Rennes University Hospital, Rennes, France.

Pierre Guéret (P)

Hematology Laboratory, Rennes University Hospital, Rennes, France.

Guillaume Mahé (G)

Vascular Medicine Unit, Rennes University Hospital, INSERM CIC 1414, Clinical Investigation Center, Univ Rennes, M2S - EA 7470, F-35033 Rennes, France.

Francis Couturaud (F)

Department of Internal Medecine and Chest Diseases, Brest University Hospital, Bretagne Occidentale University, EA 3878, CIC INSERM 1412, Brest, FCRIN INNOVTE, France.

Patrick Jégo (P)

Department of Internal Medicine and Clinical Immunology, Rennes University Hospital, Rennes, France; Univ Rennes, Rennes University Hospital, Inserm, EHESP, Irset (Institut de Recherche en Santé, Environnement et Travail) - UMR_S 1085, Rennes, France.

Isabelle Gouin-Thibault (I)

Univ Rennes, Rennes University Hospital, Inserm, EHESP, Irset (Institut de Recherche en Santé, Environnement et Travail) - UMR_S 1085, Rennes, France; Hematology Laboratory, Rennes University Hospital, Rennes, France. Electronic address: isabelle.gouin@chu-rennes.fr.

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Classifications MeSH