Fatigue after initiating rivaroxaban for venous thromboembolism.

anticoagulants fatigue pulmonary embolism rivaroxaban thrombosis venous thromboembolism venous thrombosis

Journal

Research and practice in thrombosis and haemostasis
ISSN: 2475-0379
Titre abrégé: Res Pract Thromb Haemost
Pays: United States
ID NLM: 101703775

Informations de publication

Date de publication:
May 2020
Historique:
received: 18 06 2019
revised: 05 01 2020
accepted: 07 01 2020
entrez: 18 6 2020
pubmed: 18 6 2020
medline: 18 6 2020
Statut: epublish

Résumé

Rivaroxaban was the first new oral anticoagulant approved for treatment of venous thromboembolism (VTE). Clinical trials have shown that rivaroxaban is noninferior to conventional anticoagulation for VTE in efficacy and safety. Increased fatigue after the initiation of rivaroxaban has been observed in clinical practice, but data on this potential side effect are lacking. The study aimed to evaluate development of fatigue in patients treated for VTE, comparing rivaroxaban to other anticoagulants. Patients were prospectively recruited after a diagnosis of VTE. The Fatigue Questionnaire was used to determine the level of fatigue at baseline, at 3 weeks of treatment, and either at 1 month after the discontinuation of treatment if the treatment was discontinued after 3 months or at 6 months if treatment was continued beyond this time. Data was analyzed by a linear mixed model. A total of 126 patients were included. Mean age was 59 years; 77 (61%) were males. Fifty-seven patients (45%) were diagnosed with deep vein thrombosis, 48 (38%) with pulmonary embolism, and 21 (17%) with both. Predicted changes in fatigue scores from baseline to the last measurement were -0.007 and -2.49 for the rivaroxaban and the other-anticoagulants groups, respectively, neither of which were statistically significant. No difference was detected between rivaroxaban and the other-anticoagulants group at any time point, including subgroup analysis comparing over and under 6 months of treatment duration. In this small study, our results suggest no increase in the level of fatigue after the initiation of treatment with rivaroxaban for VTE.

Sections du résumé

BACKGROUND BACKGROUND
Rivaroxaban was the first new oral anticoagulant approved for treatment of venous thromboembolism (VTE). Clinical trials have shown that rivaroxaban is noninferior to conventional anticoagulation for VTE in efficacy and safety. Increased fatigue after the initiation of rivaroxaban has been observed in clinical practice, but data on this potential side effect are lacking.
OBJECTIVE OBJECTIVE
The study aimed to evaluate development of fatigue in patients treated for VTE, comparing rivaroxaban to other anticoagulants.
METHODS METHODS
Patients were prospectively recruited after a diagnosis of VTE. The Fatigue Questionnaire was used to determine the level of fatigue at baseline, at 3 weeks of treatment, and either at 1 month after the discontinuation of treatment if the treatment was discontinued after 3 months or at 6 months if treatment was continued beyond this time. Data was analyzed by a linear mixed model.
RESULTS RESULTS
A total of 126 patients were included. Mean age was 59 years; 77 (61%) were males. Fifty-seven patients (45%) were diagnosed with deep vein thrombosis, 48 (38%) with pulmonary embolism, and 21 (17%) with both. Predicted changes in fatigue scores from baseline to the last measurement were -0.007 and -2.49 for the rivaroxaban and the other-anticoagulants groups, respectively, neither of which were statistically significant. No difference was detected between rivaroxaban and the other-anticoagulants group at any time point, including subgroup analysis comparing over and under 6 months of treatment duration.
CONCLUSION CONCLUSIONS
In this small study, our results suggest no increase in the level of fatigue after the initiation of treatment with rivaroxaban for VTE.

Identifiants

pubmed: 32548556
doi: 10.1002/rth2.12312
pii: S2475-0379(22)01997-5
pmc: PMC7292653
doi:

Types de publication

Journal Article

Langues

eng

Pagination

582-585

Informations de copyright

© 2020 The Authors. Research and Practice in Thrombosis and Haemostasis published by Wiley Periodicals, Inc on behalf of International Society on Thrombosis and Haemostasis.

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Auteurs

Tina Margrethe Karlsvik (TM)

Department of Internal Medicine Østfold Hospital Trust Grålum Norway.

Thore Langfeldt Borgenvik (TL)

Department of Surgery Østfold Hospital Trust Grålum Norway.

Mirjam Aadalen (M)

Department of Research Østfold Hospital Trust Grålum Norway.
Ulm University of Applied Science Ulm Germany.

Kristin Utne (K)

Department of Hematology-oncology Østfold Hospital Trust Grålum Norway.

Eli Førsund (E)

Department of Internal Medicine Østfold Hospital Trust Grålum Norway.

Camilla Tøvik Jørgensen (CT)

Department of Research Østfold Hospital Trust Grålum Norway.

René Holst (R)

Department of Research Østfold Hospital Trust Grålum Norway.

Lars-Petter Jelsness-Jørgensen (LP)

Department of Internal Medicine Østfold Hospital Trust Grålum Norway.
Department of Health Science Østfold University College Grålum Norway.

Waleed Ghanima (W)

Department of Internal Medicine Østfold Hospital Trust Grålum Norway.
Department of Research Østfold Hospital Trust Grålum Norway.
Department of Hematology Institute of Clinical Medicine University of Oslo Oslo Norway.

Classifications MeSH