既定の動脈硬化性心血管疾患の患者における長期的なエヴォロキュマブ
Michelle L O'Donoghue1, Robert P Giugliano1, Stephen D Wiviott1
1TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA (M.L.O., R.P.G., S.D.W., J.F.K., K.I., S.A.M., M.S.S.).
Circulation
|August 29, 2022
まとめ
エヴォロキュマブの長期使用は,高リスクの患者で心血管疾患および死亡を著しく減少させた. このPCSK9阻害剤は,プラセボと比較して有害事象の増加を示さず,8年以上にわたって持続した安全性と有効性を示しました.
科学分野:
- 心血管医学
- 薬理学について
- 臨床試験
背景:
- FOURIER試験では,エヴォロキュマブがLDL- Cと心血管疾患を減少させたことが示されました.
- エヴォロキュマブの安全性と有効性に関する長期的なデータは限られていた.
研究 の 目的:
- 動脈硬化性心血管疾患の患者におけるエヴォロキュマブの長期的な安全性と有効性を評価する.
- 長期にわたる心血管疾患と有害事象の評価
主な方法:
- FOURIER試験の患者はオープン拡張試験 (FOURIER- OLE) に登録されました.
- 主要な分析は有害事象発生率に焦点を当てた.
- 脂質値と主要心血管疾患の有害事象は,平均5. 0年の追跡期間で予測的に収集されました.
主要な成果:
- エヴォロキュマブ治療により,平均LDL- Cは30 mg/ dLとなり,その63. 2%がLDL- C< 40 mg/ dLに達した.
- 長期にわたる有害事象 (重篤な有害事象,筋肉事象,新しい糖尿病,脳卒中,神経認知事象) の割合はプラセボを上回らず,時間とともに増加しなかった.
- エボロキュマブを投与された患者は,プラセボと比較して,重大な心血管疾患のリスクが15%,心血管疾患による死亡リスクが23%低かった.
結論:
- エヴォロキュマブによる長期のLDL-C低下は安全で,8年以上にわたって良好に耐える.
- 治療開始の遅延と比較して,エヴォロキュマブは持続的な心血管リスクの減少を示した.
- この研究は,高リスクの心血管疾患の患者におけるエヴォロキュマブの長期的な効果を裏付けています.
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