慢性心不全およびエジェクション分数減少 (VICTOR) の患者におけるベリシガート: ダブルブラインド,プラセボ対照,ランダム化,第3相試験
Javed Butler1, Ciaran J McMullan2, Kevin J Anstrom3
1Baylor Scott and White Research Institute, Dallas, TX, USA; University of Mississippi, Jackson, MS, USA.
Lancet (London, England)
|September 2, 2025
まとめ
最近の悪化のない心不全の患者では,Vericiguatが心血管疾患による死亡または心不全の入院リスクを有意に低下させなかった. しかし,心臓血管疾患による死亡は,投与者グループでは少なかった.
科学分野:
- 心血管医学
- 臨床薬理学
- 心不全 の 研究
背景:
- ベリシグアットは,エジェクション分数減少 (HFrEF) の特定の心不全患者の悪化後の治療に承認されています.
- VICTOR試験では,最近の心不全の悪化のないHFrEF患者における vericiguatの有効性を調査した.
研究 の 目的:
- 最近悪化していないHFrEF患者の心血管疾患による死亡および入院に対する vericiguatの効果を評価する.
- より広いHFrEF集団において,プラセボと比較して, vericiguatの安全性と有効性を評価する.
主な方法:
- HFrEF (LVEF ≤40%) の6105人の患者が最近入院またはIV利尿剤を使用しなかった3期目のダブルブラインド,プラセボ対照試験.
- 患者はランダムに投与された投与薬 (10 mgのターゲット用量) またはプラセボに割り当てられました.
- 主要コンポジットエンドポイントは,心血管疾患による死亡または心不全による入院までの時間でした.
主要な成果:
- 主要複合評価結果は統計的に有意ではなかった (HR 0. 93; p=0. 22).
- プラセボ (11. 3%) (HR 0. 83) と比較して,受給者群では心臓血管疾患による死亡が少なくなった.
- すべての原因による死亡率は,受給者群でも低かった (12. 3% vs 14. 4%). 症状性低血圧が最も一般的な副作用でした.
結論:
- HFrEF患者では,HFrEF患者の心臓疾患による死亡または心臓不全による入院の複合エンドポイントの有意な減少は示されなかった.
- 心血管疾患による死亡の減少と全因死亡率の低下という傾向が観察されました.
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