Magazine article Drug Topics

Dabigatran as Effective as Warfarin to Prevent VTE Recurrence

Magazine article Drug Topics

Dabigatran as Effective as Warfarin to Prevent VTE Recurrence

Article excerpt


Data from the RE-MEDY trial suggest that dabigatran etexilate (Pradaxa) is as effective as warfarin for longterm, extended antithrombotic therapy in patients who have already received at least three months of anticoagulation for venous thromboembolism (VTE).

RE-MEDY randomized 1,430 patients to dabigatran and 1,426 to warfarin. Over a follow-up of six to 36 months, dabigatran's hazard ratio (HR) for the primary end point of recurrent or fatal VTE, compared with that of warfarin, was 1.44 (95% CI 0.78-2.64, P=0.01 for noninf eriority ) . Major or clinically relevant bleeding was significantly reduced in the dabigatran group, with HR 0.54 (95% CI 0.41-0.71, P<0.001).

Of note, there were significantly more cases of acute coronary syndrome (ACS) in the dabigatran group (0.9%) vs 0.2% for those who took warfarin (P=O. 02). This finding is similar to what was observed in the RE-LY trial, one of the pivotal approval trials for dabigatran. In that study, there was an increased risk of myocardial infarction in patients treated with dabigatran compared with warfarin.

Sot/to?; Sandman S, Kearon C, KakkarAK, et al Extended use of dabigatran, warfarin, or placebo in venous thromboembolism. N Engl J Med. 2013;368:709-718. NEJMoalll3697.

Clopidogrel plus aspirin shows benefit after TIA

New data presented at the International Stroke Conference suggest that a short course of aspirin plus Clopidogrel begun immediately after a transient ischemic attack (TIA) or minor stroke outperforms aspirin alone in decreasing the risk of a subsequent stroke.

The Chinese trial enrolled 5,170 patients of at least 40 years of age who had suffered a TIA or minor stroke. Within 24 hours of their symptom onset, they were randomized to one of two groups: aspirin (75-300 mg one-day loading dose followed by 75 mg/day) plus placebo, or the same aspirin regimen plus Clopidogrel (loading dose of 300 mg followed by 75 mg/day). Aspirin was discontinued after 21 days in the combination group.

The study showed that stroke occurred less frequently in those receiving both aspirin and Clopidogrel. At 90 days, the HR for stroke-free survival in the combination group was 0. …

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