関連する実験動画
2型糖尿病に対する経口薬剤併用療法における心血管的アウトカムに関するロシグリタゾンの評価 (RECORD):多センター,ランダム化,オープンラベル試験
Philip D Home1, Stuart J Pocock, Henning Beck-Nielsen
1Newcastle Diabetes Centre and Newcastle University, Newcastle upon Tyne, UK. philip.home@newcastle.ac.uk
Lancet (London, England)
|June 9, 2009
まとめ
糖尿病治療へのロシグリタゾンの追加は,全般的な心血管疾患の発生を増加させなかったが,特に女性では,心不全と骨折のリスクを高めました. この研究では,ロシグリタゾンと標準治療を5~7年にわたって比較した.
科学分野:
- 内分泌学と新陳代謝について
- 心血管医学は,心臓血管医学である.
- 薬理学 薬理学とは
背景:
- ロシグリタゾンは,II型糖尿病管理に使用されるインスリン感受剤です.
- 他の低血糖療法と比較して,その心血管安全性と有効性は評価が必要です.
研究 の 目的:
- ロシグリタゾンとメトホルミンとスルフォニル尿素の組み合わせを比較して,ロシグリタゾンで治療された2型糖尿病患者の心血管的アウトカムを評価するために.
- この患者集団におけるロシグリタゾンの比較安全性プロフィールを評価する.
主な方法:
- 2型糖尿病患者4447人を対象とした多センター,オープンラベル試験です.
- 患者は,単独療法にロシグリタゾンを加えたか,メトホルミンとスルフォニル尿素 (アクティブコントロール) の組み合わせを投与された.
- 主要エンドポイント:心血管疾患による入院または死亡;フォローアップ:5~7年.
主要な成果:
- 主要心血管エンドポイントの非劣等性は達成されました (HR 0.99).
- ロシグリタゾンは,主に女性において,心不全 (HR 2.10) と骨折のリスクを有意に増加させた.
- 平均HbA1cはロシグリタゾン群ではより低かった.
結論:
- 血糖を下げる治療にロシグリタゾンを追加すると,特に女性では,心不全と骨折のリスクが増加します.
- ロシグリタゾンは,標準的な治療法と比較して,全般的な心血管疾患または死亡率を上昇させません.
- 心筋梗塞の影響に関するデータは,まだ決定的ではありません.
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