REDUCE-IT USA:米国でランダムに選択された3146人の患者の結果
Deepak L Bhatt1, Michael Miller2, Eliot A Brinton3
1Brigham and Women's Hospital Heart & Vascular Center and Harvard Medical School, Boston, MA (D.L.B.).
Circulation
|November 12, 2019
まとめ
REDUCE- IT試験では,ICOSAPENTエチルは米国患者における心血管疾患を有意に減少させ,リスクの有力な減少を示した. この発見は全ての原因による死亡率の利点を含め,高リスクの個人に使用することを支持しています.
科学分野:
- 心血管医学
- 臨床試験
- 薬理学について
背景:
- 以前の試験では,地域による治療に対する患者の反応が異なっていたことが示された.
- REDUCE- IT試験では,イコサペントエチルによる心血管疾患のリスク低下を調査した.
- この集団における治療効果を明らかにするために,サブグループ分析は米国患者に焦点を当てた.
研究 の 目的:
- 米国内の患者におけるイコサペントエチルの特定の効果を評価する.
- REDUCE- IT試験の米国ベースのサブグループで,icosapent ethylとプラセボの有効性を比較する.
主な方法:
- REDUCE- IT試験では,高トリグリセリド値と心血管疾患の危険因子を有する8179人の患者をランダムに分けました.
- 参加者はイコサペントエチル (4g/ d) またはプラセボを受けた.
- 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,心筋梗塞,脳卒中,再血管化,または不安定な胸痛による入院でした.
主要な成果:
- 合計3146人の米国患者が分析され,試験コホートの38. 5%を占めた.
- Icosapent ethylは,米国患者における主要な複合エンドポイント (HR 0. 69) と重要な二次複合エンドポイント (HR 0. 69) を有意に減少させた.
- 心血管疾患による死亡,心筋梗塞,脳卒中,全因性死亡のリスクが著しく低下し,全因性死亡の相互作用が顕著であった (P=0. 02).
結論:
- REDUCE- IT試験の米国患者は,イコサペンチルで心血管疾患のリスクを大幅に減少させた.
- 結果は,全因死亡率を含め,米国サブグループで特に強力な利益を示しています.
- 安全性と耐受性のプロファイルは,全体的な研究集団と一致しました.
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