CONFIDENCE試験における腎臓リスクの全スペクトルにおけるフィネレノンとエンパグリフロジンの同時開始
Muthiah Vaduganathan1, Jennifer B Green2, Hiddo J L Heerspink3
1Division of Cardiovascular Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.
まとめ
CONFIDENCE試験では,フィネレノンとエンパグリフロジンの併用は,すべてのリスクレベルにおける2型糖尿病患者の腎臓疾患の進行マーカーを効果的に減少させることが示されました. この組み合わせ治療は,予想される腎臓疾患リスクカテゴリーに関係なく,一貫した効果と安全性を示しました.
科学分野:
- 腎臓科
- 内分泌学
- 臨床薬理学
背景:
- 慢性腎臓病 (CKD) と2型糖尿病 (T2D) は,世界的な健康問題です.
- 腎臓病の進行リスクを予測することは,治療戦略の調整に不可欠です.
- フィネレノンとエンパグリフロジンの組み合わせ治療は,CKDのT2Dの管理のための新しいアプローチです.
研究 の 目的:
- CKDとT2Dの患者にフィネレンロンとエンパグリフロジンを同時に投与する際の有効性と安全性を評価する.
- KDIGOのリスクカテゴリーが,この組み合わせ治療の効果と安全性に影響するかどうかを判断する.
- 尿中のアルブミン・クレアチニン比率 (UACR) と腎臓機能に対する併用療法の影響を評価する.
主な方法:
- CONFIDENCE試験は,CKDとT2Dの成人818人を対象としたダブルブラインド・ダブルダミー試験でした.
- 参加者はフィネレノンとエンパグリフロジン,フィネレノン単独,またはエンパグリフロジン単独,レニン- 血管新生系阻害剤と共に投与された.
- 主要エンドポイントは,基値から180日までの相対的なUACR変化であり,二次エンドポイントは,KDIGOリスクカテゴリーで分析された30%以上のUACR減少でした.
主要な成果:
- 併用療法により,すべてのKDIGOリスクカテゴリーにおいて,UACRが著しく低下した (低/中等: - 61. 7%,高: - 60. 7%,非常に高: - 52. 4%).
- 併用療法を受けた患者の半数以上がUACRの減少を30%以上達成し,単独療法よりも優れていた.
- 高リスクの個体では早期のeGFR低下が少なく,リスクグループ全体で安全性が一貫していた.
結論:
- フィネレノンとエンパグリフロジンの同時投与は,CKDとT2D患者の腎臓疾患マーカーを減少させるのに有効です.
- この組み合わせ治療の効果と安全性は,低,中等,高,および非常に高いKDIGOリスクカテゴリーに一致しています.
- このアプローチは,T2DとCKDの幅広い患者にとって有望な治療法です.
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