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ロフェコキシブに関連した心血管疾患: APPROVe試験の最終分析
John A Baron1, Robert S Sandler, Robert S Bresalier
1Departments of Medicine, and of Community and Family Medicine, Dartmouth Medical School, Hanover, NH, USA.
Lancet (London, England)
|October 17, 2008
まとめ
サイクロオキシゲナーゼ-2阻害剤であるロフェコキシブは,心臓発作や脳卒中を含む心血管疾患を大幅に増加させた. この高いリスクは,薬の投与を中止した後も1年間持続しました.
科学分野:
- 心血管医学は,心血管医学である.
- 胃腸内科 胃腸内科
- 薬理学 薬理学とは
背景:
- 選択的サイクロオキシゲナーゼ-2 (COX-2) 抑制は,心血管疾患のリスクと関連しています.
- APPROVe研究では,当初,ポリプの予防のためにロフェコキシブを評価しました.
- この分析は,治療後の長期的な心血管疾患のアウトカムに焦点を当てています.
研究 の 目的:
- APPROVe研究参加者の長期追跡後の心血管疾患のアウトカムを評価する.
- プラセボと比較して,ロフェコキシブで治療された患者における主要な有害心血管イベント (APTCエンドポイント) の発生率を決定する.
主な方法:
- 多センター,ランダム化,プラセボ対照,ダブルブラインド試験で,大腸腺腫の病歴のある2587人の患者が参加した.
- 治療終了後少なくとも1年間,心血管疾患 (心筋梗塞,脳卒中,心血管疾患による死亡) の追跡調査.
- エンドポイントの危険比率を分析するために使用されたコックス比例リスク回帰法.
主要な成果:
- ロフェコキシブ群では合計59のAPTCエンドポイントが発生し,プラセボ群では34であった (HR 1.79,95%CI 1.17-2.73;p=0.006).
- ロフェコキシブを中止した最初の1年でAPTCのエンドポイントのリスクの増加が観察されましたが,統計的に有意ではありませんでした.
- APTCのエンドポイントに対する危険性比は,フォローアップ期間中に一貫したままでした.
結論:
- ロフェコキシブの使用は,主要な心血管疾患の有害事象の発生率が高くなります.
- ロフェコキシブに関連した心血管疾患のリスクは,早期に現れ,治療中止後でも1年間持続するようです.
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