Dabigatran Etexilate is Effective and Safe for the Extended Prevention of Venous Thromboembolism Following Total Hip Replacement Eriksson BI, Dahl OE,

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Presentation transcript:

Dabigatran Etexilate is Effective and Safe for the Extended Prevention of Venous Thromboembolism Following Total Hip Replacement Eriksson BI, Dahl OE, Rosencher N, Kurth AA, v. Dijk N, Frosticks SP, Hettiarachchi R, Hantel S, Schnee J, Büller HR Presented at the XXIst Congress of International Society on Thrombosis and Haemostasis (ISTH) 2007 Meeting, July 6-12th in Geneva, Switzerland.

Dabigatran Etexilate is Effective and Safe for the Extended Prevention of VTE Following Total Hip Replacement Prophylaxis beyond hospital discharge is recommended to reduce the risk of venous thromboembolism (VTE) after hip replacement surgery Oral thromboprophylaxis not requiring monitoring is an advantage in orthopedic patients Dabigatran etexilate is an oral direct thrombin inhibitor under evaluation for this indication Background: Eriksson B.I., et al. Presented at ISTH 2007 in Geneva, Switzerland, abstract #O-W-049.

Dabigatran Etexilate is Effective and Safe for the Extended Prevention of VTE Following Total Hip Replacement To evaluate the thrombo-prophylactic use of dabigatran etexilate beyond hospital discharge to reduce the risk of VTE after hip replacement surgery Objective: Eriksson B.I., et al. Presented at ISTH 2007 in Geneva, Switzerland, abstract #O-W-049.

Dabigatran Etexilate is Effective and Safe for the Extended Prevention of VTE Following Total Hip Replacement In a double-blind non-inferiority Phase III study, 3494 patients undergoing total hip replacement were randomized to treatment for 28 to 35 days with: –Dabigatran etexilate, 220 mg or 150 mg once-daily, starting with a half-dose 1 to 4 hours after surgery –Or subcutaneous enoxaparin 40 mg once-daily, starting the evening before surgery Methods: Eriksson B.I., et al. Presented at ISTH 2007 in Geneva, Switzerland, abstract #O-W-049.

Dabigatran Etexilate is Effective and Safe for the Extended Prevention of VTE Following Total Hip Replacement The composite of total venous thromboembolism and death from all-causes (primary efficacy outcome), and major bleeding, during treatment were monitored All efficacy and safety outcome events were centrally adjudicated by blinded independent committees Patients were followed-up for 3 months after surgery Methods: Eriksson B.I., et al. Presented at ISTH 2007 in Geneva, Switzerland, abstract #O-W-049.

Study Design Eriksson B.I., et al. Presented at ISTH 2007 in Geneva, Switzerland, abstract #O-W-049. Post-op treatment Dabigatran Etexilate 220 mg qd oral dose days of treatment 1-4 hr pre-op Dabigatran Etexilate 75 mg qd oral dose 12 hrs pre-op Enoxaparin 40mg qd s.c. 1-4 hr pre-op Dabigatran Etexilate 110 mg qd oral dose Post-op treatment Dabigatran Etexilate 150 mg qd oral dose Post-op treatment Enoxaparin 40mg qd s.c pts randomized 3 month follow-up evaluation

Dabigatran Etexilate is Effective and Safe for the Extended Prevention of VTE Following Total Hip Replacement The median treatment duration was 33 days, with 87% of patients receiving treatment for 28 to 35 days Both doses were non-inferior to enoxaparin according to predefined criteria Results: Eriksson B.I., et al. Presented at ISTH 2007 in Geneva, Switzerland, abstract #O-W-049.

Dabigatran Etexilate is Effective and Safe for the Extended Prevention of VTE Following Total Hip Replacement There was no significant difference in major bleeding rates between the groups The incidence of liver enzyme elevations and acute coronary events during the treatment or during the follow-up period did not differ significantly between the groups Results: Eriksson B.I., et al. Presented at ISTH 2007 in Geneva, Switzerland, abstract #O-W-049.

Results Dabigatran Etexilate 150mg Dabigatran Etexilate 220mg Enoxaparin 40mg Primary Efficacy Outcome 8.6% absolute difference,-0.7%; 95% confidence interval [CI], -2.9 to % absolute difference,-1.9%; 95% confidence interval [CI], -0.6 to % Major Bleeding Rates 1.3%2.0%1.6% Acute Coronary Events No significant difference Liver Enzymes No significant difference Eriksson B.I., et al. Presented at ISTH 2007 in Geneva, Switzerland, abstract #O-W-049.

Dabigatran Etexilate is Effective and Safe for the Extended Prevention of VTE Following Total Hip Replacement Oral dabigatran etexilate once daily, administered for a median of 33 days, was as effective as enoxaparin in reducing the risk of venous thromboembolism after total hip replacement surgery, with a similar safety profile Conclusion: Eriksson B.I., et al. Presented at ISTH 2007 in Geneva, Switzerland, abstract #O-W-049.