Tags

Type your tag names separated by a space and hit enter

Secondary prevention of venous thromboembolism with the oral direct thrombin inhibitor ximelagatran.
N Engl J Med. 2003 Oct 30; 349(18):1713-21.NEJM

Abstract

BACKGROUND

For many patients with venous thromboembolism, secondary prevention with vitamin K antagonists is not extended beyond six months, since the risk of recurrence may be outweighed by the risk of major bleeding.

METHODS

In a double-blind, multicenter trial, we randomly assigned 1233 patients with venous thromboembolism who had undergone six months of anticoagulant therapy to extended secondary prevention with the oral direct thrombin inhibitor ximelagatran (24 mg) or placebo, taken twice daily, for 18 months without monitoring of coagulation. At base line, bilateral ultrasonography of the legs and perfusion lung scanning were performed.

RESULTS

Data from 612 patients in the ximelagatran group and 611 in the placebo group were analyzed. The occurrence of the primary end point, symptomatic recurrent venous thromboembolism, was confirmed in 12 patients assigned to ximelagatran and 71 patients assigned to placebo (hazard ratio, 0.16; 95 percent confidence interval, 0.09 to 0.30; P<0.001). Death from any cause occurred in 6 patients in the ximelagatran group and 7 patients in the placebo group, and bleeding occurred in 134 patients and 111 patients, respectively (hazard ratio, 1.19; 95 percent confidence interval, 0.93 to 1.53; P=0.17). The incidence of major hemorrhage was low (six events in the ximelagatran group and five in the placebo group), and none of these hemorrhages were fatal. The cumulative risk of a transient elevation of the alanine aminotransferase level to more than three times the upper limit of normal was 6.4 percent in the ximelagatran group, as compared with 1.2 percent in the placebo group (P<0.001).

CONCLUSIONS

Oral ximelagatran was superior to placebo for the extended prevention of venous thromboembolism. There was no significant increase in the frequency of bleeding complications, but there was an increase in the number of patients with a transient elevation in the alanine aminotransferase level.

Authors+Show Affiliations

Coagulation Unit, Department of Medicine, Karolinska Hospital, Stockholm, Sweden. sam.schulman@ks.seNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

14585939

Citation

Schulman, Sam, et al. "Secondary Prevention of Venous Thromboembolism With the Oral Direct Thrombin Inhibitor Ximelagatran." The New England Journal of Medicine, vol. 349, no. 18, 2003, pp. 1713-21.
Schulman S, Wåhlander K, Lundström T, et al. Secondary prevention of venous thromboembolism with the oral direct thrombin inhibitor ximelagatran. N Engl J Med. 2003;349(18):1713-21.
Schulman, S., Wåhlander, K., Lundström, T., Clason, S. B., & Eriksson, H. (2003). Secondary prevention of venous thromboembolism with the oral direct thrombin inhibitor ximelagatran. The New England Journal of Medicine, 349(18), 1713-21.
Schulman S, et al. Secondary Prevention of Venous Thromboembolism With the Oral Direct Thrombin Inhibitor Ximelagatran. N Engl J Med. 2003 Oct 30;349(18):1713-21. PubMed PMID: 14585939.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Secondary prevention of venous thromboembolism with the oral direct thrombin inhibitor ximelagatran. AU - Schulman,Sam, AU - Wåhlander,Karin, AU - Lundström,Torbjörn, AU - Clason,Solveig Billing, AU - Eriksson,Henry, AU - ,, PY - 2003/10/31/pubmed PY - 2003/11/6/medline PY - 2003/10/31/entrez SP - 1713 EP - 21 JF - The New England journal of medicine JO - N. Engl. J. Med. VL - 349 IS - 18 N2 - BACKGROUND: For many patients with venous thromboembolism, secondary prevention with vitamin K antagonists is not extended beyond six months, since the risk of recurrence may be outweighed by the risk of major bleeding. METHODS: In a double-blind, multicenter trial, we randomly assigned 1233 patients with venous thromboembolism who had undergone six months of anticoagulant therapy to extended secondary prevention with the oral direct thrombin inhibitor ximelagatran (24 mg) or placebo, taken twice daily, for 18 months without monitoring of coagulation. At base line, bilateral ultrasonography of the legs and perfusion lung scanning were performed. RESULTS: Data from 612 patients in the ximelagatran group and 611 in the placebo group were analyzed. The occurrence of the primary end point, symptomatic recurrent venous thromboembolism, was confirmed in 12 patients assigned to ximelagatran and 71 patients assigned to placebo (hazard ratio, 0.16; 95 percent confidence interval, 0.09 to 0.30; P<0.001). Death from any cause occurred in 6 patients in the ximelagatran group and 7 patients in the placebo group, and bleeding occurred in 134 patients and 111 patients, respectively (hazard ratio, 1.19; 95 percent confidence interval, 0.93 to 1.53; P=0.17). The incidence of major hemorrhage was low (six events in the ximelagatran group and five in the placebo group), and none of these hemorrhages were fatal. The cumulative risk of a transient elevation of the alanine aminotransferase level to more than three times the upper limit of normal was 6.4 percent in the ximelagatran group, as compared with 1.2 percent in the placebo group (P<0.001). CONCLUSIONS: Oral ximelagatran was superior to placebo for the extended prevention of venous thromboembolism. There was no significant increase in the frequency of bleeding complications, but there was an increase in the number of patients with a transient elevation in the alanine aminotransferase level. SN - 1533-4406 UR - https://www.unboundmedicine.com/medline/citation/14585939/Secondary_prevention_of_venous_thromboembolism_with_the_oral_direct_thrombin_inhibitor_ximelagatran_ L2 - http://www.nejm.org/doi/full/10.1056/NEJMoa030104?url_ver=Z39.88-2003&amp;rfr_id=ori:rid:crossref.org&amp;rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -