まとめ
低用量のシブラフィバンをアスピリンに添加しても,急性冠動脈症候群の患者のアウトカムが改善されず,出血が増加しました. 高用量シブラフィバンは,死亡率増加の傾向を示した.
科学分野:
- 心臓病学 心臓病学
- 薬理学 薬理学とは
- クリニック・トライアル 臨床試験
背景:
- 以前の試験では,急性冠動脈症候群後の二次予防のためにアスピリンよりもシブラフィバンの利点はないことを示しました.
- 第2回SYMPHONY試験では,低用量シブラフィバンとアスピリン (LDS+A) と高用量シブラフィバン (HDS) をアスピリン単独に対して試験した.
研究 の 目的:
- 急性冠動脈症候群患者の二次予防のために,低用量または高用量シブラフィバンとアスピリンの併用による有効性と安全性を評価する.
- アスピリン単独療法に対するLDS+AおよびHDS療法のアウトカムを比較する.
主な方法:
- 第2回SYMPHONY試験の早期終了は,6671人の患者の初期結果によるものです.
- 治療期間の中央値は90日でした.
- プライマリエンドポイント:死亡,心筋梗塞 (MI),または重度の再発性不血症. 二次的エンドポイントには,死亡率,心筋梗塞率,重大出血事件が含まれていました.
主要な成果:
- アスピリン (9.3%) とLDS+A (9.2%) の間のプライマリエンドポイントでは有意な差はありません.
- 高用量シブラフィバン (HDS) は,プライマリエンドポイントの非有意な増加 (10.5%) を示しました.
- 主な出血は,アスピリン単独 (4.0%) と比較して,LDS+A (5.7%) で有意に高かった. HDSは出血の有意な増加を示さなかった (4.6%).
- HDSは,有意に多くの死亡またはMI (OR 1.43) と高死亡率単独 (OR 1.83) と関連していました.
結論:
- 低用量のシブラフィバンとアスピリンの併用は,急性冠動脈症候群後の二次予防の結果を改善せず,出血のリスクを高めます.
- 高用量シブラフィバンは,死亡率の増加と死亡またはMIの有意な増加の傾向を示しました.
- 現在の証拠は,急性冠動脈症候群の患者でシブラフィバンとアスピリンの併用の使用を支持していません.
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