アイゼンメンガー症候群の患者におけるマシテンタンの評価
Michael A Gatzoulis1, Michael Landzberg1, Maurice Beghetti2
1The Royal Brompton Hospital and National Heart & Lung Institute, Imperial College, London, United Kingdom (M.A.G.).
Circulation
|December 28, 2018
まとめ
MAESTRO研究では,アイゼンメンガー症候群患者の運動能力は改善されなかった. このエンドセリン受容体の抗体が16週間の試験でプラセボに比べて有意な効果を示さなかった.
科学分野:
- 心臓病科
- 肺科
- 薬理学について
背景:
- アイゼンメンガー症候群は,右から左にシャントリングした先天性心疾患による重度の肺高血圧を伴う.
- MAESTRO研究では,エンドセリン受容体の抗体であるマシテンタンが,アイゼンメンガー症候群の治療に用いられました.
研究 の 目的:
- アイゼンメンガー症候群の患者の運動能力の改善におけるマシテンタンの有効性と安全性を評価する.
- 機能的クラス,NT-proBNPレベル,および血液動力学に対するマシテンタンの影響を評価する.
主な方法:
- マルチセンター,ダブルブラインド,ランダム化,プラセボ制御,16週間のフェーズIII試験.
- 226人の患者 (12歳以上,WHO機能クラスII-III) は,マシテタン10 mgを1日またはプラセボで投与された.
- 主要評価点: 歩行距離の6分の変化; 副次評価点: WHO機能クラスの変化.
主要な成果:
- マシテンタンは,プラセボと比較して,6分間の歩行距離を有意に改善しなかった (平均差は-4. 7m,P=0. 612).
- グループ間のWHO機能的クラス改善の有意な差は認められなかった (OR0. 53).
- マシテンタンはNT-proBNP濃度と肺血管抵抗指数 (PVRi) を減少させた.
結論:
- マシテンタンは,アイゼンメンガー症候群における運動能力の改善においてプラセボよりも優れていることを示さなかった.
- NT-proBNPやPVRiのような探索的措置で潜在的可能性を示したものの,主要エンドポイントは満たされなかった.
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