臨床神経学

<シンポジウム16―3>心房細動患者の抗凝固療法―新時代への対応―

トロンビン阻害薬への期待と問題点

内山 真一郎

東京女子医科大学神経内科〔〒162―8666 東京都新宿区河田町8―1〕

Dabigatran is a direct thrombin inhibitor, does not require blood coagulation monitoring and limitation of vitamin K intake as well as very few drug interactions, and thus expected to be an oral anticoagulant alternative to warfarin. Randomized Evaluation of Long Term Anticoagulant Therapy (RE-LY) was conducted to determine non-inferiority of dabigatran against warfarin as an international multicenter-cooperative randomized trial in patients with non-valvular atrial fibrillation (NVAF). The results showed not only non-inferiority of dabigatran but also superiority of high-dose dabigatran in efficacy and of low-dose dabigatran in safety. In a sub-analysis of RE-LY in NVAF patients with history of stroke or TIA, who are at high risk of intracranial hemorrhage with anticoagulants, hemorrhagic stroke was much less frequent in patients on either dose of dabigatran than in those on warfarin. In a sub-analysis of RE-LY in Japanese patients with NVAF, the results showed a consistency of the efficacy and safety profiles of dabigatran with the results of the global RE-LY trial. Use of dabigatran should be contraindicated in NVAF patients with renal insufficiency because some cases with fatal bleeding have been reported in a post marketing survey.
Full Text of this Article in Japanese PDF (205K)

(臨床神経, 51:1004−1006, 2011)
key words:直接トロンビン阻害薬,心房細動,脳卒中予防,ワルファリン,大規模臨床試験

(受付日:2011年5月19日)