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再血管化なしで治療されたACS患者のプラズグレルおよびクロピドグレルの延長治療中の血小板機能:TRILOGY ACS血小板機能サブスタディ
Paul A Gurbel1, David Erlinge, E Magnus Ohman
1Sinai Center for Thrombosis Research, Baltimore, Maryland, USA.
JAMA
|November 3, 2012
まとめ
プラスグレルは,急性冠動脈症候群 (ACS) の患者において,クロピドグレルよりも低血小板反応性を示した. しかし,主要な心血管疾患の有害事象の有意な差異は2つの薬剤間で観察されず,血小板の反応性と結果との明確な関連も認められませんでした.
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:
- 急性冠動脈症候群 (ACS) の患者の血小板機能検査結果と臨床結果の関係は,再血管化なしで医学的に管理されるが,依然として不明確である.
- これらの関係を理解することは,ACS患者の抗血小板治療の最適化に不可欠です.
研究 の 目的:
- 薬で治療されたACS患者におけるクロピドグレルとプラスグレルの血小板反応性を比較する.
- この患者集団における血小板反応性と臨床結果の関連性を評価する.
主な方法:
- TRILOGY ACS試験 (2008年~2011年) は,医学的に管理された不安定な心房痛またはSTセグメントの上昇のない心筋梗塞の患者を登録しました.
- 血小板機能サブスタディでは,クロピドグレルまたはプラスグレルでアスピリンを投与された患者で,さまざまな時間点でのP2Y12反応単位 (PRU) を評価しました.
- 主要な有効性エンドポイントは,心臓血管疾患による死亡,心筋梗塞,または脳卒中を30ヶ月間組み合わせたものです.
主要な成果:
- プラスグレルは,異なる患者サブグループ (年齢,体重) でクロピドグレルと比較して,PRU値が有意に低下した.
- 血小板反応性の差異にもかかわらず,30ヶ月後にプラズグレルとクロピドグレル群の1次有効性エンドポイントにおいて有意な差異は認められなかった (17.2%対18.9%,P=0.29).
- 継続的なPRU値または治療中の高血小板反応性と,主効性エンドポイントの発生との間に有意な関連は観察されなかった.
結論:
- 医学的に管理されたACS患者では,患者特性と投与量に関係なく,プラズグレルはクロピドグレルと比較して,血小板の反応性を一貫して低下させた.
- 血小板の反応性の観察された差異は,2つの薬剤間の主要な心血管疾患の有害事象の有意な差異に変換されませんでした.
- PRUで測定された血小板の反応性は,この研究集団における不血症の結果と有意な関連性を示さなかった.
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