FUEL 試験の結果

David J Goldberg¹, Victor Zak², Bryan H Goldstein³

¹Division of Cardiology, The Children's Hospital of Philadelphia, Perelman School of Medicine, PA (D.J.G., S.W., M.G.M., S.M.P.).

Circulation

|November 19, 2019

まとめ

ウデナフィルは,呼吸器無酸素値での運動能力を改善したが,ピーク酸素消費量を有意に増加させなかった. この研究では,この集団における最大運動能力の潜在的利点が強調されています.

科学分野:

心血管医学
小児心臓科
臨床薬理学

背景:

ポンタン手術は肺血管抵抗を拡大するユニークな循環状態 (全腔肺連結) を生み出します
この循環は時間の経過とともに心血管の効率と運動能力の低下につながります
Fontan患者の生理学を改善し,薬物治療をガイドする厳密な臨床試験が欠けている.

研究の目的:

フォントン症の患者における運動能力の改善におけるウデナフィルの有効性を評価する.
ウデナフィルのピーク運動酸素消費とサブマキシマル運動パラメータへの影響を評価する.

主な方法:

Fontan Udenafil Exercise Longitudinal (FUEL) 試験は,400人の参加者を対象とした第3相臨床試験でした.
参加者はランダムにウデナフィル (87. 5 mg 1日2回) またはプラセボを投与されました.
主なアウトカムは,ピーク運動時の酸素消費量の変化であり,二次的なアウトカムは,サブマキシマム運動量とバイオマーカーを含んでいた.

主要な成果:

ウデナフィルの治療は,プラセボと比較してピーク酸素消費を有意に増加させなかった (2. 8% 対 - 0. 2%,P=0. 071).
しかし,呼吸器無酸素値の分析では,ウデナフィルの酸素消費量 (P=0. 012),呼吸器の二酸化炭素相当量 (P=0. 014),および作業速度 (P=0. 021) の有意な改善が示されました.
心筋機能指数,反応性高血症指数,または脳型ナトリウレチンペプチド濃度において有意な差異は認められなかった.

結論:

FUEL試験では,ウデナフィルの投与 (87. 5 mg 1日2回) がピーク運動時の酸素消費を改善しなかった.
ウデナフィルは,呼吸器無酸素値での運動能力のいくつかの測定値の改善と関連していました.
フォントンの生理学における最大運動能力の強化におけるウデナフィルの役割は,さらなる研究によって探求され得る.

キーワード:

フォントン手続運動テスト心臓障害,先天性ホスフォディエステラゼ5阻害剤

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