再結合ヒト凝固因子VIIaの使用後の血栓塞栓性有害事象
Kathryn A O'Connell1, Jennifer J Wood, Robert P Wise
1Division of Epidemiology, Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, Md 20852-1448, USA. oconnellk@cber.fda.gov
JAMA
|January 19, 2006
まとめ
重篤な血栓塞栓性イベントは,特に血友病のない患者で,再結合ヒト凝固因子VIIa (rFVIIa) と報告されています. これらの集団における安全性と有効性を確認するために,さらなるランダム化試験が必要である.
科学分野:
- 医薬品監視 医薬品監視
- 血液学 ヘマトロジ
- トロンボシス (Thrombosis) とは
背景:
- リコンビナントヒト凝固因子VIIa (rFVIIa) は,阻害剤を投与した血友病患者のために1999年にFDAによって承認されました.
- rFVIIaのオフレーベルの使用は,そのライセンス取得以来増加しています.
研究 の 目的:
- FDAの有害事象報告システム (AERS) に報告されたrFVIIaに関連した重篤な血栓塞栓性有害事象 (AEs) をレビューする.
主な方法:
- 1999年3月から2004年12月までのAERSデータベースのレビューでは,rFVIIaに関連した血栓塞栓性AEが特定されました.
- 承認された用途とラベル付けされていない用途の両方の自発的な報告,およびライセンス後試験からの深刻なAEが含まれていました.
主要な成果:
- 431件のrFVIIa AE報告のうち,185件の血栓塞栓事件が報告されました.
- ほとんどのイベント (151) は,多くの場合,活発に出血している患者で,ラベル付けされていない指示で発生しました.
- 脳血管事故,心筋梗塞,肺/静脈血栓症は一般的な有害事象であり,報告された死亡の72%がこれらのイベントに起因している.
結論:
- 血栓塞栓性AEは,しばしば重症で,rFVIIaと関連しており,特にラベル付けされていない用途では特にそうでした.
- 併用薬や既にある疾患などの混同要因は,最終的な安全性分析を制限する.
- ランダム化対照試験は,非血友性患者におけるrFVIIaの安全性と有効性を確立するために不可欠です.
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