United Therapeutics Corporation, 1040 Spring Street, Silver Spring, MA 20910, USA.
Patient Advocacy.
Future Cardiol. 2023 Apr;19(5):229-239. doi: 10.2217/fca-2022-0108. Epub 2023 Jul 19.
WHAT IS THIS SUMMARY ABOUT?: Here, we summarize the results from the INCREASE study, originally published in the . The INCREASE study looked at how well a medication called inhaled treprostinil works and how safe it is, compared to placebo (a fake medication), in adults who have pulmonary hypertension associated with interstitial lung disease or PH-ILD.
WHAT WERE THE RESULTS?: A total of 326 participants took part in the study. Half the participants took inhaled treprostinil and the other half took placebo. After 16 weeks, the INCREASE study showed that participants with PH-ILD who took inhaled treprostinil could walk around 31 meters (102 feet) further than the participants who took placebo. Participants taking inhaled treprostinil also had a decrease in NT-proBNP, which is a protein found in the blood. Lower NT-proBNP levels suggest that the heart is functioning better compared with higher levels. Participants taking inhaled treprostinil showed a decrease of NT-proBNP of 15% compared to a 46% increase in participants taking placebo. More participants taking placebo had worsening of their PH-ILD (33%) compared to participants taking inhaled treprostinil (∼23%). The most common side effects reported in the study were cough, headache and shortness of breath.
WHAT DO THE RESULTS MEAN?: In the INCREASE study, on average, people with PH-ILD taking inhaled treprostinil, were able to be more active and had less chance of their PH-ILD getting worse, compared to placebo. Based on inhaled treprostinil showing positive results in most people with PH-ILD in this study, the drug has been approved in the USA for the treatment of PH-ILD.
这篇摘要总结了最初发表在《》杂志上的 INCREASE 研究结果。该研究旨在比较一种名为吸入性曲前列尼尔的药物与安慰剂(一种假药物)在患有与间质性肺疾病相关的肺动脉高压或 PH-ILD 的成年人中的疗效和安全性。
共有 326 名参与者参与了这项研究。一半的参与者接受吸入性曲前列尼尔治疗,另一半接受安慰剂治疗。16 周后,INCREASE 研究表明,接受吸入性曲前列尼尔治疗的 PH-ILD 患者比接受安慰剂治疗的患者多走了约 31 米(102 英尺)。接受吸入性曲前列尼尔治疗的患者的 NT-proBNP 也有所下降,NT-proBNP 是血液中发现的一种蛋白质。较低的 NT-proBNP 水平表明与较高水平相比,心脏功能更好。与接受安慰剂治疗的患者相比,接受吸入性曲前列尼尔治疗的患者的 NT-proBNP 下降了 15%,而接受安慰剂治疗的患者的 NT-proBNP 增加了 46%。与接受吸入性曲前列尼尔治疗的患者相比(约 23%),更多接受安慰剂治疗的患者的 PH-ILD 恶化(33%)。研究中报告的最常见副作用是咳嗽、头痛和呼吸急促。
在 INCREASE 研究中,平均而言,与安慰剂相比,接受吸入性曲前列尼尔治疗的 PH-ILD 患者能够更加活跃,并且 PH-ILD 恶化的机会更少。基于吸入性曲前列尼尔在这项研究中的大多数 PH-ILD 患者中显示出积极的结果,该药物已在美国获得批准用于治疗 PH-ILD。