Zwicke Diane L, Restrepo-Jaramillo Ricardo, Alnuaimat Hassan, Gordon Kathryn, Broderick Meredith, Edwards Lisa D, Allmon Andrew, Leary Peter J
Aurora St. Luke's Medical Center, University of Wisconsin, Milwaukee, WI, USA.
University of South Florida, Tampa, FL, USA.
Pulm Circ. 2021 Mar 2;11(1):2045894021998203. doi: 10.1177/2045894021998203. eCollection 2021 Jan-Mar.
Oral treprostinil has recently been shown to delay disease progression in patients with pulmonary arterial hypertension in a long-term outcomes study. The potential advantages of an oral formulation have resulted in patients transitioning from inhaled to oral treprostinil. The current study reports a retrospective analysis of patients who transitioned from treatment with inhaled to oral treprostinil. A multicenter retrospective chart review was conducted for 29 patients with pulmonary hypertension that transitioned from inhaled to oral treprostinil. Data were collected from inhaled treprostinil initiation and patients were followed until discontinuation of oral treprostinil or the end of the observation period. Persistence was calculated using Kaplan-Meier estimates. Prior to transition to oral treprostinil, patients had received inhaled treprostinil for a median of 643 (IQR: 322-991) days and 52% of patients were New York Heart Association/World Health Organization Functional Class III. For patients that cross-titrated between formulations, the median time to complete the cross titration was 24 (IQR: 1-57) days. At 16- and 24-weeks post-transition, oral treprostinil persistence was 86 and 76%, respectively. Persistence was 59% at 52 weeks post-transition. Clinical stability for the majority of patients at first follow-up post-transition was suggested based on available New York Heart Association/World Health Organization Functional Classification. Transitions from inhaled to oral treprostinil appeared safe and tolerable in the short-term. Additional prospective studies are needed to fully evaluate the safety and efficacy of transitions from inhaled to oral treprostinil.
在一项长期预后研究中，口服曲前列尼尔最近已被证明可延缓肺动脉高压患者的疾病进展。口服制剂的潜在优势已促使患者从吸入用曲前列尼尔转换为口服曲前列尼尔。本研究报告了对从吸入用曲前列尼尔转换为口服曲前列尼尔的患者的回顾性分析。对29例从吸入用曲前列尼尔转换为口服曲前列尼尔的肺动脉高压患者进行了多中心回顾性病历审查。收集了从开始使用吸入用曲前列尼尔的数据，并对患者进行随访，直至口服曲前列尼尔停药或观察期结束。使用Kaplan-Meier估计值计算持续率。在转换为口服曲前列尼尔之前，患者接受吸入用曲前列尼尔的中位时间为643天（四分位间距：322 - 991天），52%的患者为纽约心脏协会/世界卫生组织功能分级III级。对于在两种制剂之间交叉滴定的患者，完成交叉滴定的中位时间为24天（四分位间距：1 - 57天）。转换后16周和24周时，口服曲前列尼尔的持续率分别为86%和76%。转换后52周时持续率为59%。根据现有的纽约心脏协会/世界卫生组织功能分级，提示大多数患者在转换后首次随访时临床稳定。从吸入用曲前列尼尔转换为口服曲前列尼尔在短期内似乎是安全且可耐受的。需要更多的前瞻性研究来全面评估从吸入用曲前列尼尔转换为口服曲前列尼尔的安全性和有效性。
