併用療法 (REACT) によって制御されていない重度の慢性閉塞性肺疾患の患者における悪化に対するロフルミラストの効果:多センターランダム化制御試験
Fernando J Martinez1, Peter M A Calverley2, Udo-Michael Goehring3
1Weill Cornell Medical College, New York, NY, USA; University of Michigan Health System, Ann Arbor, MI, USA.
Lancet (London, England)
|February 17, 2015
まとめ
ロフルミラストは,呼吸用コルチコステロイドおよび長期間有効ベータアゴニスト療法を受けている重度の慢性閉塞性肺疾患患者の悪化を著しく軽減しました. この発見は,高リスク患者のための貴重な追加治療としてロフルミラストを裏付けています.
科学分野:
- 肺内科 肺内科 肺内科
- 薬理学 薬理学とは
- クリニック・トライアル 臨床試験
背景:
- 重度の慢性閉塞性肺疾患 (COPD) は,頻繁に悪化することが特徴です.
- 吸入用コルチコステロイド (ICS) や長作用ベータアゴニスト (LABA) を含む現在の治療法は,すべての患者で悪化を完全に制御できない可能性があります.
- すでにICS/LABAの組み合わせを受けている患者の追加療法としてのロフルミラストの有効性は,以前は知られていなかった.
研究 の 目的:
- 背景ICS/LABA治療を受けている重度のCOPD患者の悪化を軽減するロフルミラストの有効性を評価する.
- ICS/LABA治療にロフルミラストを追加する際の安全性と耐受性を評価する.
主な方法:
- 1年間のダブルブラインド,プラセボ対照,マルチセンターの第3~4期試験 (REACT研究) で,1945人の重度のCOPD患者さんを対象とした.
- 患者は,既存のICS/LABA併用療法に加えて,1日1回500μgの経口ロフルミラストまたはプラセボを1対1でランダムに割り当てられました.
- 主要評価項目は,治療の意図によって分析された,患者"人当たりの年間中等から重度のCOPD悪化率でした.
主要な成果:
- ロフルミラストは,ネガティブな二項回帰を用いたプラセボ (p=0.0424) と比較して,中等から重度のCOPDの悪化を14.2%統計的に有意に減少させた.
- プライマリ・ポアソン回帰分析では13.2%の減少 (p=0.0529) が示されたが,感度分析では利益が確認された.
- 副作用はロフルミラスト群でより頻繁に発生した (67%対59%),離脱率が高かった (11%対5%).
結論:
- ロフルミラストは,ICS/LABAおよびチオトロピウムを投与した場合でも,重度の慢性肺炎を患った高リスクのCOPD患者の悪化や入院を減らすのに有効です.
- ICS/LABA療法にロフルミラストを添加することは,重度のCOPDの頻繁な悪化を管理するための潜在的な治療の選択肢を提供します.
- この集団でロフルミラストの投与を開始する際の有害事象の増加は,慎重に患者のモニタリングを正当化します.
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