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Prognostic factors for recurrence of venous thromboembolism (VTE) or bleeding during long-term secondary prevention of VTE with ximelagatran.
Thromb Haemost 2005; 94(3):522-7TH

Abstract

The oral direct thrombin inhibitor ximelagatran (24 mg twice daily) has been shown to significantly reduce the incidence of recurrent venous thromboembolism (VTE) vs. placebo over 18 months, with no significant influence on bleeding (THRIVE III). The influence of potential prognostic factors on the risk of recurrent VTE or major and/or minor bleeding and their impact on ximelagatran treatment was evaluated in the THRIVE III study population. The effect of sex, age, body weight, renal function, malignancy, type of initial VTE event, and history of previous VTE events was investigated in the intention-to-treat population using Cox proportionate hazard modelling. Ximelagatran was administered to 612 patients and placebo to 611 patients. Within the placebo group, risk of recurrent VTE was higher among men than women (hazard ratio [HR]: 2.50,95% confidence interval [CI] 1.49,4.17), and in patients with one or more than one previous VTE event (HR: 1.73,95% CI 1.00, 2.99). There was a higher risk of bleeding among women than men in both the ximelagatran (HR: 1.49, 95% CI 1.06, 2.09) and placebo (HR: 1.48, 95% CI 1.01, 2.15) groups, and in placebo-treated patients with an initial pulmonary embolism (HR: 1.53, 95% CI 1.06,2.23) compared to those with initial deep vein thrombosis. There were no significant interactions between treatment effect and any of the potential prognostic factors. In conclusion, the superior efficacy of ximelagatran vs. placebo was maintained in all subgroups. Long-term use of oral ximelagatran, without coagulation monitoring or dose adjustment, should be feasible and well tolerated in a wide cross-section of patients for the secondary prevention of VTE.

Authors+Show Affiliations

Department of Medicine, Sahlgrenska University Hospital/Ostra, Gothenburg, Sweden. henryeriksson@swipnet.seNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Clinical Trial, Phase III
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

16268466

Citation

Eriksson, Henry, et al. "Prognostic Factors for Recurrence of Venous Thromboembolism (VTE) or Bleeding During Long-term Secondary Prevention of VTE With Ximelagatran." Thrombosis and Haemostasis, vol. 94, no. 3, 2005, pp. 522-7.
Eriksson H, Lundström T, Wåhlander K, et al. Prognostic factors for recurrence of venous thromboembolism (VTE) or bleeding during long-term secondary prevention of VTE with ximelagatran. Thromb Haemost. 2005;94(3):522-7.
Eriksson, H., Lundström, T., Wåhlander, K., Clason, S. B., & Schulman, S. (2005). Prognostic factors for recurrence of venous thromboembolism (VTE) or bleeding during long-term secondary prevention of VTE with ximelagatran. Thrombosis and Haemostasis, 94(3), pp. 522-7.
Eriksson H, et al. Prognostic Factors for Recurrence of Venous Thromboembolism (VTE) or Bleeding During Long-term Secondary Prevention of VTE With Ximelagatran. Thromb Haemost. 2005;94(3):522-7. PubMed PMID: 16268466.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Prognostic factors for recurrence of venous thromboembolism (VTE) or bleeding during long-term secondary prevention of VTE with ximelagatran. AU - Eriksson,Henry, AU - Lundström,Torbjörn, AU - Wåhlander,Karin, AU - Clason,Solveig Billing, AU - Schulman,Sam, AU - ,, PY - 2005/11/5/pubmed PY - 2006/6/7/medline PY - 2005/11/5/entrez SP - 522 EP - 7 JF - Thrombosis and haemostasis JO - Thromb. Haemost. VL - 94 IS - 3 N2 - The oral direct thrombin inhibitor ximelagatran (24 mg twice daily) has been shown to significantly reduce the incidence of recurrent venous thromboembolism (VTE) vs. placebo over 18 months, with no significant influence on bleeding (THRIVE III). The influence of potential prognostic factors on the risk of recurrent VTE or major and/or minor bleeding and their impact on ximelagatran treatment was evaluated in the THRIVE III study population. The effect of sex, age, body weight, renal function, malignancy, type of initial VTE event, and history of previous VTE events was investigated in the intention-to-treat population using Cox proportionate hazard modelling. Ximelagatran was administered to 612 patients and placebo to 611 patients. Within the placebo group, risk of recurrent VTE was higher among men than women (hazard ratio [HR]: 2.50,95% confidence interval [CI] 1.49,4.17), and in patients with one or more than one previous VTE event (HR: 1.73,95% CI 1.00, 2.99). There was a higher risk of bleeding among women than men in both the ximelagatran (HR: 1.49, 95% CI 1.06, 2.09) and placebo (HR: 1.48, 95% CI 1.01, 2.15) groups, and in placebo-treated patients with an initial pulmonary embolism (HR: 1.53, 95% CI 1.06,2.23) compared to those with initial deep vein thrombosis. There were no significant interactions between treatment effect and any of the potential prognostic factors. In conclusion, the superior efficacy of ximelagatran vs. placebo was maintained in all subgroups. Long-term use of oral ximelagatran, without coagulation monitoring or dose adjustment, should be feasible and well tolerated in a wide cross-section of patients for the secondary prevention of VTE. SN - 0340-6245 UR - https://www.unboundmedicine.com/medline/citation/16268466/Prognostic_factors_for_recurrence_of_venous_thromboembolism__VTE__or_bleeding_during_long_term_secondary_prevention_of_VTE_with_ximelagatran_ L2 - https://medlineplus.gov/bloodthinners.html DB - PRIME DP - Unbound Medicine ER -