症状のある心不全と貧血の患者でアルファダーベポエチンによるランダム化二重盲検試験

Jalal K Ghali¹, Inder S Anand, William T Abraham

¹Wayne State University, Detroit, Mich, USA. jghali@med.wayne.edu

Circulation

|January 16, 2008

まとめ

心不全 (HF) の患者の貧血をアルファダーボエチンで治療すると,運動や生活の質が有意に改善されませんでした. しかし,治療はよく耐えており,死亡率と入院率が低下する傾向を示した.

科学分野:

心臓病学心臓病学
血液学ヘマトロジ
クリニック・トライアル臨床試験

背景:

貧血は,心不全 (HF) の患者の不良結果の既知の独立したリスク因子です.
心不全における貧血の研究 (STAMINA-HeFT) は,HFにおける貧血治療を評価するために設計された大規模,多センター,ランダム化,ダブルブラインド,プラセボ対照試験です.

研究の目的:

症状のある心不全患者の貧血の治療におけるダーベポエチンアルファの有効性を評価する.
HF患者の運動能力,機能的状態,および生活の質に対する貧血治療の影響を決定する.

主な方法:

症状のあるHFと貧血 (血球9.0〜12.5g/dL) を有する319人の患者は,ランダムに1年間アルファダベルポエチンまたはプラセボを投与されました.
主なエンドポイントは,27週後のトレッドミルの運動時間の変化でした.
副次的エンドポイントには,ニューヨーク心臓協会のクラス,生活の質の変化,全因死亡率またはHF入院の複合が含まれていました.

主要な成果:

ダーベポエチンアルファは,プラセボと比較してヘモグロビン濃度を効果的に増加させた (P<0.001).
運動の持続時間,ニューヨーク心臓協会の授業,生活の質の有意な改善は観察されなかった.
すべての原因による死亡率またはHF入院のリスクの減少に向けた傾向が認められた (HR 0.68; P=0.10).

結論:

症状のあるHFと貧血の患者でアルファダーベポエチンの治療は,有意な臨床的利益をもたらさなかった.
ダーベポエチンアルファはよく耐えており,ヘモグロビン濃度を効果的に上昇させました.
罹病率と死亡率の減少に向けた潜在的な傾向は,さらなる調査を正当化しています.

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