バルサルタンによる全身右心室機能に対する効果: ダブルブラインド,ランダム化,プラセボ対照試験
Teun van der Bom1, Michiel M Winter, Berto J Bouma
1Department of Cardiology, Academic Medical Center, Amsterdam, Netherlands.
Circulation
|December 19, 2012
まとめ
バルサルタンは,大動脈の転移を患った患者の全身右心室射出分子を改善しませんでした. しかし,バルサタン治療は3年間にわたって右心室の体積と質量の増加を減少させた.
科学分野:
- 心臓病学 心臓病学
- クリニック・トライアル 臨床試験
- 薬理学 薬理学とは
背景:
- システム性右心室の患者におけるアンジオテンシンII受容体阻害剤 (ARB) の有効性は不明である.
- 大動脈の転移 (TGA) は,有意な臨床的影響を伴う状態である全身右心室を引き起こす可能性があります.
研究 の 目的:
- システム性右心室疾患の患者の管理におけるARBバルサータンの役割を調査する.
- TGA患者におけるヴァルサルタンによる右心室機能,運動能力,および生活の質への影響を評価する.
主な方法:
- 多センター,ダブルブラインド,ランダム化制御試験で,TGAによる全身性右心室疾患の88人の患者が参加した.
- 患者は,バルサタン160mgを1日2回,またはプラセボを3年間投与された.
- 主要エンドポイント:心血管磁気共鳴画像またはマルチローウ検出器コンピュータトモグラフィーで評価された右心室放出分数の変化.
主要な成果:
- 3年間のヴァルサタン治療は,全身右心室噴出分数,運動能力,または生活の質に有意な効果を示さなかった.
- バルサルタンはプラセボと同様の安全性プロファイルと関連しており,深刻な有害事象は報告されていません.
- プラセボと比較して,ヴァルサルタン群では,右心室の終末ダイアストリック体積と質量の有意に小さい増加が観察されました.
結論:
- バルサルタンは,右心室排泄分数,運動能力,または全身右心室を有する患者の生活の質に重大な利点を提供していません.
- バルサルタンは,右心室の体積と質量の増加を緩和する好ましい効果を示した.
- この研究では,ヴァルサルタンが,この患者集団における心室リモデルの管理における潜在的な役割を示唆しています.
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