PubMed日本語 - 肺動脈高血圧症の治療のための経口treprostinil単独療法の有効性と安全性:無作為比較試験。―QLifePro医療翻訳医療翻訳 QLifePro


Efficacy and safety of oral treprostinil monotherapy for the treatment of pulmonary arterial hypertension: a randomized, controlled trial.


Published date



Zhi-Cheng Jing, Keyur Parikh, Tomas Pulido, Carlos Jerjes-Sanchez, R James White, Roblee Allen, Adam Torbicki, Kai-Feng Xu, David Yehle, Kevin Laliberte, Carl Arneson, Lewis J Rubin


Shanghai Pulmonary Hospital, Tongji University School of Medicine, No. 507 Zhengmin Rd, Yangpu District, Shanghai, China 20043.


BACKGROUND: Pulmonary arterial hypertension (PAH) is a progressive, fatal disease with no cure. Parenteral and inhaled prostacyclin analogue therapies are effective for the treatment of PAH, but complicated administration requirements can limit the use of these therapies in patients with less severe disease. This study was designed to evaluate the safety and efficacy of the oral prostacyclin analogue treprostinil diolamine as initial treatment for de novo PAH.


METHODS AND RESULTS: Three hundred forty-nine patients (intent-to-treat population) not receiving endothelin receptor antagonist or phosphodiesterase type-5 inhibitor background therapy were randomized (treprostinil, n=233; placebo, n=116). The primary analysis population (modified intent-to-treat) included 228 patients (treprostinil, n=151; placebo, n=77) with access to 0.25-mg treprostinil tablets at randomization. The primary end point was change from baseline in 6-minute walk distance at week 12. Secondary end points included Borg dyspnea index, clinical worsening, and symptoms of PAH. The week 12 treatment effect for 6-minute walk distance (modified intent-to-treat population) was 23.0 m (P=0.0125). For the intent-to-treat population, 6-minute walk distance improvements were observed at peak (26.0 m; P=0.0001) and trough (17.0 m; P=0.0025) plasma study drug concentrations. Other than an improvement in the combined 6-minute walk distance/Borg dyspnea score, there were no significant changes in secondary end points. Oral treprostinil therapy was generally well tolerated; the most common adverse events (intent-to-treat) were headache (69%), nausea (39%), diarrhea (37%), and pain in jaw (25%).


CONCLUSIONS: Oral treprostinil improves exercise capacity in PAH patients not receiving other treatment. Oral treprostinil could provide a convenient, first-line prostacyclin treatment option for PAH patients not requiring more intensive therapy.


CLINICAL TRIAL REGISTRATION: URL: Unique identifier: NCT00325403.


本研究は、新規のPAHの初回治療として経口プロスタシクリンの類似体treprostinil diolamineの安全性および有効性を評価するようになっていた。
第一義的分析集団(治療に対する変更された意図)は0.25-mg treprostinil錠剤への接近を有する228例の患者(treprostinil、n=151;プラセボ、n=77)をランダム化で含んだ。
治療に対する意図集団のために、6-分の道のり距離改善がピーク(26.0m; P=0.0001)とトラフ(17.0m; P=0.0025)血漿試験薬濃度で観察されたこと。

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