スタチン療法に関連するリスク:ランダム化臨床試験の体系的な概要
Amir Kashani1, Christopher O Phillips, JoAnne M Foody
1Section of Cardiovascular Medicine, Department of Medicine, Yale University School of Medicine, New Haven, Conn, USA.
Circulation
|December 13, 2006
まとめ
スタチンは一般的に安全であり,プラセボと比較して筋肉や肝臓の損傷のリスクが有意に増加することはありません. しかし,スタチンの治療は,トランスアミナーゼ濃度のわずかな上昇と関連しています.
科学分野:
- 心血管医学は,心臓血管医学である.
- 薬理学 薬理学とは
- クリニック・トライアル 臨床試験
背景:
- スタチンは,心血管疾患のリスクを効果的に軽減します.
- 副作用に関する懸念は,スタチンの処方箋を制限する可能性があります.
- この研究では,合併症リスクを評価するために,スタチン試験を体系的にレビューしました.
研究 の 目的:
- スタチン療法による運動器系,腎臓,肝臓の合併症のリスクを定量化するために.
- スタチン単独療法とプラセボの安全性プロフィールをランダム化試験で評価する.
主な方法:
- スタチンのランダム化試験のシステマティック・オーバービュー (MEDLINE検索,1966-2005).
- 超脂血症の成人を含む,ダブルブラインドスタチン対プラセボ, >=100人の患者.
- 筋痛,クレアチンキナーゼ,ラブドミオリシス,トランスアミナーゼの上昇,および有害事象の中止に関するデータを分析した.
主要な成果:
- 35件の試験で74,102人の被験者 (フォローアップ1〜65ヶ月).
- 筋痛,クレアチンキナーゼ値上昇,ラブドミオリシス,または治療中止の有意な増加はありません.
- トランスアミナーゼ値上昇 (RD,4.2;95%CI,1.5〜6.9) の有意な絶対値上昇が観察されました.
結論:
- スタチンの治療は,トランスアミナーゼの上昇のわずかな過剰リスクを示しますが,筋痛症,クリエチンキナーゼの上昇,ラブドミオリシス,または離脱は示しません.
- これらの発見を日常の実践,特に高リスクの患者グループで確認するためにさらなる研究が必要である.
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