ローズヴァスタチンの安全性,一般的な臨床実務で使用される: 販売後の分析
Alawi A Alsheikh-Ali1, Marietta S Ambrose, Jeffrey T Kuvin
1Molecular Cardiology Research Institute, Department of Medicine, Tufts-New England Medical Center, 750 Washington St, Boston, MA 02111, USA.
Circulation
|May 25, 2005
まとめ
一般的なスタチンであるロスウバスタチンは,他のスタチンと比較して,ラブドミオリシスや腎臓の問題などの深刻な有害事象の発生率が高かった. これらのリスクは,適度な投与量であっても,治療の初期に観察されました.
科学分野:
- 医薬品監視 医薬品監視
- 心血管疾患の管理について
- 薬物安全性評価 薬物安全性評価について
背景:
- スタチンは,失脂症と心血管疾患の予防のための主要な治療法です.
- 初期の研究と報告に基づいて,新しいスタチンであるロスウバスタチンの安全性に関する懸念があります.
研究 の 目的:
- 他のスタチンと比較してロスウバスタチンの安全性プロフィールを評価する.
- ロスウバスタチン関連有害事象の報告を,販売開始の最初の年に評価する.
主な方法:
- FDAからのロスウバスタチンに対する有害事象報告 (AER) のレビュー.
- IMS Healthのデータを用いて,100万件の処方箋あたりのAER率を計算した.
- ロスウバスタチンのAER率をアトルバスタチン,シムバスタチン,プラバスタチンと比較した.
主要な成果:
- ロスウバスタチンは,ラブドミオリシス,タンパク質尿,腎不全,または腎不全に対するAERの有意に高い割合を示しました.
- これらの重篤なイベントは,しばしば治療の初期に,そして控えめなロスウバスタチン用量で発生しました.
- 肝臓と筋肉の毒性を含む二次分析では,ロスウバスタチンに対するAERの増加も認められた.
結論:
- この発見は,一般的な臨床実務におけるロスウバスタチンの相対的な安全性に関する懸念を裏付けている.
- ロスウバスタチンは,他の広く使用されているスタチンと比較して,重篤な有害事象のリスクが高い可能性があります.
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