Extended use of dabigatran, warfarin, or placebo in venous thromboembolism.
In: ISSN: 0028-4793, 2013
academicJournal
Zugriff:
International audience ; BACKGROUND: Dabigatran, which is administered in a fixed dose and does not require laboratory monitoring, may be suitable for extended treatment of venous thromboembolism. METHODS: In two double-blind, randomized trials, we compared dabigatran at a dose of 150 mg twice daily with warfarin (active-control study) or with placebo (placebo-control study) in patients with venous thromboembolism who had completed at least 3 initial months of therapy. RESULTS: In the active-control study, recurrent venous thromboembolism occurred in 26 of 1430 patients in the dabigatran group (1.8%) and 18 of 1426 patients in the warfarin group (1.3%) (hazard ratio with dabigatran, 1.44; 95% confidence interval [CI], 0.78 to 2.64; P=0.01 for noninferiority). Major bleeding occurred in 13 patients in the dabigatran group (0.9%) and 25 patients in the warfarin group (1.8%) (hazard ratio, 0.52; 95% CI, 0.27 to 1.02). Major or clinically relevant bleeding was less frequent with dabigatran (hazard ratio, 0.54; 95% CI, 0.41 to 0.71). Acute coronary syndromes occurred in 13 patients in the dabigatran group (0.9%) and 3 patients in the warfarin group (0.2%) (P=0.02). In the placebo-control study, recurrent venous thromboembolism occurred in 3 of 681 patients in the dabigatran group (0.4%) and 37 of 662 patients in the placebo group (5.6%) (hazard ratio, 0.08; 95% CI, 0.02 to 0.25; P<0.001). Major bleeding occurred in 2 patients in the dabigatran group (0.3%) and 0 patients in the placebo group. Major or clinically relevant bleeding occurred in 36 patients in the dabigatran group (5.3%) and 12 patients in the placebo group (1.8%) (hazard ratio, 2.92; 95% CI, 1.52 to 5.60). Acute coronary syndromes occurred in 1 patient each in the dabigatran and placebo groups. CONCLUSIONS: Dabigatran was effective in the extended treatment of venous thromboembolism and carried a lower risk of major or clinically relevant bleeding than warfarin but a higher risk than placebo. (Funded by Boehringer Ingelheim; RE-MEDY and RE-SONATE ...
Titel: |
Extended use of dabigatran, warfarin, or placebo in venous thromboembolism.
|
---|---|
Autor/in / Beteiligte Person: | Schulman, Sam ; Kearon, Clive ; Kakkar, Ajay K ; Schellong, Sebastian ; Eriksson, Henry ; Baanstra, David ; Kvamme, Anne Mathilde ; Friedman, Jeffrey ; Mismetti, Patrick ; Goldhaber, Samuel Z ; Mottier, Dominique ; Department of Medicine (DM - McMaster) ; McMaster University Hamilton, Ontario ; Thrombosis Research Institute (AKK) ; University College of London London (UCL) ; Dresden-Friedrichstadt Hospital (DRESDEN-FRIEDRICHSTADT HOSPITAL) ; Hospital, Dresden-Friedrichstadt ; Centre d'Investigation Clinique - Epidemiologie Clinique/essais Cliniques Saint Etienne ; Université Jean Monnet Saint-Étienne (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM) ; Groupe de recherche sur la thrombose (GRT (EA 3065)) ; Université Jean Monnet Saint-Étienne (UJM) ; Cardiovascular Division (SZG) ; Brigham and Women's Hospital Boston ; Centre d'Investigation Clinique (CIC - Brest) ; Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM) ; Groupe d'Etude de la Thrombose de Bretagne Occidentale (GETBO) ; Université de Brest (UBO)-Institut Brestois Santé Agro Matière (IBSAM) ; Université de Brest (UBO)-Université de Brest (UBO) |
Link: | |
Zeitschrift: | ISSN: 0028-4793, 2013 |
Veröffentlichung: | HAL CCSD ; Massachusetts Medical Society, 2013 |
Medientyp: | academicJournal |
DOI: | 10.1056/NEJMoa1113697 |
Schlagwort: |
|
Sonstiges: |
|