ナトリウム・グルコース・コトランスポーター2阻害剤の投与開始後の心血管疾患のアウトカムとリスク: EASEL集団ベースコホート研究
Jacob A Udell1, Zhong Yuan2, Toni Rush3
1Department of Medicine, Cardiovascular Division, Peter Munk Cardiac Centre, Toronto General Hospital and Women's College Hospital, University of Toronto, Canada (J.A.U.) jay.udell@utoronto.ca.
Circulation
|November 15, 2017
まとめ
2型糖尿病患者の心不全入院や死亡率などの心血管疾患のリスクを軽減します. しかし,SGLT2iの使用は,下肢の切断のリスクの増加と関連していました.
科学分野:
- 心血管医学
- 内分泌学
- 薬理学について
背景:
- 臨床試験では,ナトリウム・グルコース・コトランスポーター2阻害剤 (SGLT2i) が心臓血管に有益だが,潜在的なリスクも伴うことが示されている.
- 以前の試験では,個々のエンドポイントまたは特定の安全性に関する問題を完全に評価する統計的力がない可能性があります.
研究 の 目的:
- 2型糖尿病と既定の心血管疾患の患者でSGLT2阻害剤を投与した際の心血管上の利点と安全性のリスクを評価する.
- SGLT2阻害剤と他の抗高血糖剤の使用者の間で,主要な心血管疾患の発生率,心不全の入院,死亡率,および膝下肢切断を比較する.
主な方法:
- 米国国防総省の軍事保健システム (2013年−2016年) のデータを用いて,人口ベースのコホート研究を実施した.
- SGLT2阻害剤を投与した2型糖尿病および既定の心血管疾患の患者は,他の抗高血糖剤を投与した患者と比較した.
- 複合的エンドポイント,個々のエンドポイント,および膝下の下肢切断の危険比率を評価するために,条件付きのコックスモデルが使用されました.
主要な成果:
- SGLT2阻害剤の投与開始は,あらゆる原因による死亡率と心不全による入院率が著しく低下した (HR,0. 57; 95% CI,0. 50- 0. 65).
- SGLT2阻害剤の使用は,重大な心血管疾患のリスクを低下させた (HR,0. 67; 95% CI,0. 60- 0. 75).
- 主にカナグリフロジンに関連したSGLT2阻害剤の開始で,膝の下肢切断のほぼ2倍のリスクが観察されました (HR,1. 99; 95% CI,1. 12~3. 51).
結論:
- 高リスクのコホートでは,SGLT2阻害剤は,死亡率,心不全の入院,および主要な心血管不良を減らす,重要な心血管上の利点を示した.
- この研究では,SGLT2阻害剤の投与開始に伴う膝下肢切断の危険性が高く,慎重に検討する必要があります.
- この研究は,サブグループ分析のためにパワーアップされていないため,断肢のリスクが特定のSGLT2阻害剤に特異的なものか,またはクラス全体の影響を決定するためにさらなる研究が必要です.
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