RE-MEDY

A randomized, multicenter, double-blind, active controlled study to investigate the efficacy and safety of dabigatran etexilate, 150 mg b.i.d administered orally (capsules) for 18 months, compared to warfarin tablets (target INR) for the secondary prevention of venous thromboembolism (2011)

Condition

Secondary prevention of VTE after 3–6 months successful treatment for acute symptomatic DVT or PE

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Objective

To evaluate the efficacy and safety of dabigatran compared to warfarin for the secondary prevention of VTE

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Trial design

Randomized, double-blind non-inferiority phase III study
Active treatment: dabigatran 150 mg p.o. twice daily for 6–36 months and warfarin placebo (n=1430)
Control treatment: warfarin (INR 2.0–3.0) for 6–36 months and dabigatran placebo (n=1426)

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Endpoints

Primary efficacy endpoint: composite of recurrent symptomatic VTE and deaths related to VTE during the treatment period Secondary efficacy endpoints: composite of recurrent symptomatic VTE and all deaths, symptomatic DVT, symptomatic PE, deaths related to VTE and all deaths
Safety endpoint: bleeding events, acute coronary syndromes and other adverse events

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Trial participants

2856 patients who had initially received 3–12 months of anticoagulant therapy for acute symptomatic DVT or PE

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Results

Efficacy outcome: The primary efficacy endpoint, the composite of recurrent VTE and VTE-related deaths, occurred in 26 (1.8%) of 1430 patients treated with dabigatran and in 18 (1.3%) of 1426 patients treated with warfarin (hazard ratio 1.44; p=0.027 for non-inferiority). The rate of symptomatic DVT was higher with dabigatran (1.2% vs. 0.9%), as well as the rate of symptomatic non-fatal PE (0.7% vs. 0.4%)
Safety outcome: There were 13 major bleeding events (0.9%) in the dabigatran group and 25 (1.8%) in the warfarin group (relative risk reduction 48%; p=0.058). Any bleeding occurred in 277 patients (19%) on treatment with dabigatran and in 373 patients (26%) on warfarin (relative risk reduction 29%; p<0.001). Acute coronary syndromes were observed in 13 patients (0.9%) on treatment with dabigatran and in 3 patients (0.2%) on warfarin (p=0.02). 17 patients in the dabigatran group and 19 patients in the warfarin group have died. Other adverse events were also similar with the two treatments

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Summary

Efficacy outcome: Dabigatran was as effective as well-controlled warfarin in the extended treatment of VTE and secondary prevention of symptomatic VTE
Safety outcome: Treatment with the direct thrombin inhibitor was associated with a reduced risk for bleeding but an increased incidence of acute coronary events

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Reference

(1) ClinicalTrials.gov (NCT00329238)
(2) Schulman S, Eriksson H, Goldhaber SZ, Kakkar AKL, Kearon C, Kvamme AM, Mismetti P, Schellong S, Schnee J. Dabigatran or warfarin for extended maintenance therapy of venous thromboembolism. ISTH 2011; July 28. Journal of Thrombosis and Haemostasis 2011;9 (Suppl 2):731; Abstract O-TH-033

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Corresponding author

Sam Schulman, M.D., Ph.D., Thrombosis Service, HHS-General Hospital, 237 Barton Street East, Hamilton, ON L8L 2X2, Canada, e-mail: schulms@mcmaster.ca

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