絞り込み

16533

広告

映画「007」の次回作監督は日系アメリカ人 (NHK)

世界的に人気のスパイ映画「007」シリーズの次回作の監督に、日系アメリカ人のキャリー・フクナガさんが選ばれました。 「007」シリーズの25作目の監督に選ばれた...

  1. [企業] 武田 Molecular Te...
  2. 匿名化サービス悪用、追跡困難か Zaif...
  3. [企業] 全身投与で病変のみに作用する治...
  4. G7、海のプラごみ対策議論 (デイリース...

ニュース一覧

Safety, pharmacokinetics, and reversal of apixaban anticoagulation with andexanet alfa.

著者 Siegal D , Lu G , Leeds JM , Karbarz M , Castillo J , Mathur V , Hutchaleelaha A , Sinha U , Kitt M , McClure M , Hollenbach SJ , Curnutte JT , Conley PB , Crowther M
Blood Adv.2017 Sep 26 ; 1(21):1827-1838.
この記事をPubMed上で見るPubMedで表示
この記事をGoogle翻訳上で見る Google翻訳で開く

スターを付ける スターを付ける     (49view , 0users)

Full Text Sources

Medical

Direct factor Xa (FXa) inhibitors lack a specific reversal agent for emergencies such as major bleeding or urgent surgery. Andexanet alfa, a modified, catalytically inactive, recombinant human FXa derivative, reverses anticoagulant effect by binding and sequestering FXa inhibitors. This original report of safety and dose-finding, phase 1 and 2 randomized, double-blind, placebo-controlled studies, investigated various doses of andexanet in healthy volunteers. Phase 1 evaluated the safety and pharmacokinetics of andexanet (n = 24) or placebo (n = 8). In phase 2, andexanet (n = 36) or placebo (n = 18) was administered following steady-state apixaban dosing (5 mg twice daily for 6 days); safety, pharmacokinetics, and pharmacodynamics were assessed. Andexanet plasma concentration increased proportionally with dose, with rapid elimination (terminal elimination half-life, 4.35-7.5 hours). Following apixaban treatment, andexanet rapidly (≤2 minutes) and dose dependently reduced unbound apixaban concentration vs placebo (51% to 89% vs 5% reduction; all P < .05), decreased anti-FXa activity (67.8% to 95.0% vs 7.1% reduction; all P < .05), and restored thrombin generation in 67% to 100% vs 6% of subjects (all P < .01), maintaining these effects during continuous 45- and 120-minute infusions. Andexanet was well tolerated. Nine subjects had mild/moderate infusion reactions not associated with hemodynamic changes or respiratory compromise that generally resolved without intervention or dose reduction. There were no thrombotic events or other serious safety issues. In conclusion, andexanet reversed apixaban-mediated effects on pharmacodynamic markers of anticoagulation in healthy volunteers within minutes after administration and for the duration of infusion. This trial was registered at www.clinicaltrials.gov as #NCT01758432.
PMID: 29296829 [PubMed]
印刷用ページを開く Endnote用テキストダウンロード