日本间质性肺病肺动脉高压患者吸入曲普瑞替尼的疗效、安全性和药代动力学

IF 2.4 Q2 RESPIRATORY SYSTEM
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引用次数: 0

摘要

背景在美国进行的 INCREASE 试验表明,吸入曲普瑞替尼可改善肺动脉高压伴间质性肺病(PH-ILD)患者的运动能力。然而,该试验并未进行血液动力学和药代动力学测量。本试验的目的是评估吸入曲普瑞替尼对日本 PH-ILD 患者的血液动力学和运动能力的疗效、安全性和药代动力学(PK)。吸入曲普瑞替尼的剂量为3次/次(18微克)/次,每天4次,然后逐渐增加剂量,最大剂量为12次/次(72微克)/次。主要终点是肺血管阻力指数(PVRI)和6分钟步行距离峰值(6MWD)从基线到第16周的变化。终点还包括其他疗效参数、安全性和 PK。第16周时,PVRI较基线下降了-40.1%(95% CI,-53.1至-27.2),6MWD峰值增加了13.0米(95% CI,-15.0至49.0)。最常报告的曲普瑞替尼不良反应是咳嗽、乏力和血压下降。结论采用与 INCREASE 试验相同的给药方案吸入曲普瑞替尼治疗可改善日本 PH-ILD 患者的血液动力学和运动能力,且具有良好的耐受性和安全性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Efficacy, safety, and pharmacokinetics of inhaled treprostinil in Japanese patients with pulmonary hypertension associated with interstitial lung disease

Background

The INCREASE trial, conducted in the United States, showed that inhaled treprostinil improved exercise capacity in pulmonary hypertension associated with interstitial lung disease (PH-ILD). However, hemodynamic and pharmacokinetic measurements were not performed in the trial. The objective of this trial was to evaluate the efficacy on hemodynamics and exercise capacity, safety, and pharmacokinetics (PK) of inhaled treprostinil in Japanese patients with PH-ILD.

Methods

This trial was a multicenter, non-randomized, open-label, single-arm trial of patients with PH-ILD. Inhaled treprostinil was administered at 3 breaths (18 μg)/session four times daily, and the dose was gradually increased to a maximum of 12 breaths (72 μg)/session. The primary endpoints were the change of pulmonary vascular resistance index (PVRI) and peak 6-min walking distance (6MWD) from baseline to week 16. Endpoints also included other efficacy parameters, safety, and PK.

Results

Twenty patients received inhaled treprostinil. At week 16, PVRI decreased from baseline by −40.1% (95% CI, −53.1 to −27.2) and peak 6MWD increased by 13.0 m (95% CI, −15.0 to 49.0). The most frequently reported adverse events related with treprostinil were cough, malaise and blood pressure decreased. PK was similar to those in pulmonary arterial hypertension (PAH) patients.

Conclusions

Treatment with inhaled treprostinil using the same dosing regimen as in the INCREASE trial resulted in improvements in hemodynamics and exercise capacity with a favorable tolerability and safety profile in Japanese patients with PH-ILD.

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来源期刊
Respiratory investigation
Respiratory investigation RESPIRATORY SYSTEM-
CiteScore
4.90
自引率
6.50%
发文量
114
审稿时长
64 days
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