Subcutaneous adjusted-dose unfractionated heparin vs fixed-dose low-molecular-weight heparin in the initial treatment of venous thromboembolism.

Détails

ID Serval
serval:BIB_C7818216A62D
Type
Article: article d'un périodique ou d'un magazine.
Collection
Publications
Titre
Subcutaneous adjusted-dose unfractionated heparin vs fixed-dose low-molecular-weight heparin in the initial treatment of venous thromboembolism.
Périodique
Archives of Internal Medicine
Auteur(s)
Prandoni P., Carnovali M., Marchiori A.
Collaborateur(s)
Galilei Investigators
ISSN
0003-9926 (Print)
ISSN-L
0003-9926
Statut éditorial
Publié
Date de publication
2004
Peer-reviewed
Oui
Volume
164
Numéro
10
Pages
1077-1083
Langue
anglais
Notes
Publication types: Clinical Trial ; Comparative Study ; Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
Résumé
BACKGROUND: Few reports have addressed the value of unfractionated heparin (UFH) or low-molecular-weight heparin in treating the full spectrum of patients with venous thromboembolism (VTE), including recurrent VTE and pulmonary embolism.
METHODS: In an open, multicenter clinical trial, 720 consecutive patients with acute symptomatic VTE, including 119 noncritically ill patients (16.5%) with pulmonary embolism and 102 (14.2%) with recurrent VTE, were randomly assigned to treatment with subcutaneous UFH with dose adjusted by activated partial thromboplastin time by means of a weight-based algorithm (preceded by an intravenous loading dose), or fixed-dose (adjusted only to body weight) subcutaneous nadroparin calcium. Oral anticoagulant therapy was started concomitantly and continued for at least 3 months. We recorded the incidence of major bleeding during the initial heparin treatment and that of recurrent VTE and death during 3 months of follow-up.
RESULTS: Fifteen (4.2%) of the 360 patients assigned to UFH had recurrent thromboembolic events, as compared with 14 (3.9%) of the 360 patients assigned to nadroparin (absolute difference between rates, 0.3%; 95% confidence interval, -2.5% to 3.1%). Four patients assigned to UFH (1.1%) and 3 patients assigned to nadroparin (0.8%) had episodes of major bleeding (absolute difference between rates, 0.3%; 95% confidence interval, -1.2% to 1.7%). Overall mortality was 3.3% in each group.
CONCLUSIONS: Subcutaneous UFH with dose adjusted by activated partial thromboplastin time by means of a weight-based algorithm is as effective and safe as fixed-dose nadroparin for the initial treatment of patients with VTE, including those with pulmonary embolism and recurrent VTE.
Mots-clé
Adult, Aged, Dose-Response Relationship, Drug, Drug Administration Schedule, Female, Follow-Up Studies, Heparin/administration & dosage, Heparin/adverse effects, Heparin, Low-Molecular-Weight/administration & dosage, Heparin, Low-Molecular-Weight/adverse effects, Humans, Injections, Subcutaneous, Male, Middle Aged, Pulmonary Embolism/diagnosis, Pulmonary Embolism/drug therapy, Recurrence, Risk Assessment, Severity of Illness Index, Single-Blind Method, Survival Rate, Treatment Outcome, Venous Thrombosis/diagnosis, Venous Thrombosis/drug therapy
Pubmed
Open Access
Oui
Création de la notice
14/02/2013 16:30
Dernière modification de la notice
09/05/2019 1:06
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