関連する実験動画
安定した冠動脈疾患と左心房シストリック機能不全 (BEAUTIFUL) の患者に対するイバブラジン:ランダム化,ダブルブラインド,プラセボ対照試験
Kim Fox1, Ian Ford, P Gabriel Steg
1Royal Brompton Hospital, London, UK.
Lancet (London, England)
|September 2, 2008
まとめ
イバブラジン (心拍数を低下させる薬) は,冠動脈疾患を有するすべての患者において,心血管のアウトカムを改善しなかった. しかし,心拍数が70bpm以上の患者の心筋梗塞と再血管化を減少させた.
科学分野:
- 心臓病学 心臓病学
- 薬理学 薬理学とは
背景:
- イバブラジンは,シノアトリアルノード内のI (f) 電流を選択的に阻害し,他の心臓機能に影響を与えることなく心拍数を低下させます.
- 左心室内静脈機能不全 (LVSD) を伴う冠動脈疾患 (CAD) は,心血管疾患に重大なリスクを伴います.
研究 の 目的:
- CADおよびLVSDの患者の心血管疾患による死亡および罹患率を低減するイバブラディンの有効性を評価する.
- イバブラジンによる心拍数低下が,この患者集団における臨床結果を改善するかどうかを判断する.
主な方法:
- ランダム化,ダブルブラインド,プラセボ対照試験で,CADとエジェクション分数<40%の適格患者10,917人が参加しました.
- 患者は,標準的な心血管薬に加えて,イバブラジン (一日に2回7.5mgに定位) またはプラセボを投与されました.
- 主要エンドポイントは,心血管疾患による死亡,心筋梗塞,心不全による入院の複合体であり,治療の意図によって分析された.
主要な成果:
- イバブラジンはプラセボと比較して,心臓の鼓動を1分間に6回効果的に低下させ,ベータブロッカーと併用しても,安全性に関する懸念は認められませんでした.
- 薬剤は,全体的な研究集団におけるプライマリ複合エンドポイント (HR 1.00,p=0.94) に有意な影響を及ぼさなかった.
- 発症時の心拍数≥70bpmのサブグループでは,イバブラディンは,心筋梗塞 (HR 0.64,p=0.001) と冠動脈再血管化 (HR 0.70,p=0.016) のために入院を大幅に減少させた.
結論:
- イバブラジンによる心拍数低下は,安定したCADおよびLVSDの患者の心的結果を普遍的に改善するものではありません.
- イバブラジンは,高出血脈率 (≥70bpm) の患者で,特定の冠動脈疾患の発生を減らすのに役立つ可能性があります.
- 追加の研究は,LV機能が保存されたCAD患者における心拍数管理の役割を洗練することができます.
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