来自日本一项前瞻性非介入研究的中期数据:riociguat治疗慢性血栓栓塞性肺动脉高压(CTEPH)的安全性。PA3054六世- 52 - 5 62 SP - PA3054盟田边,这个日本AU - Ogo,武盟-波多野,Masaru AU - Tazaki Yoichi盟——Sunaya Toshiyuki盟——Saikawa晶盟,坂口Toshiaki Y1 - 2018/09/15 UR - //www.qdcxjkg.com/content/52/suppl_62/PA3054.abstract N2 -背景:Riociguat在日本被批准用于肺动脉高压和肺动脉内膜切除术后不可手术或持续性/复发性慢性肺动脉高压的治疗。目的:了解riociguat在日本常规临床治疗CTEPH安全性的上市后信息。方法:多中心、前瞻性、非介入性研究(NCT02117791)。主要结果:经过12个月的强制观察和7年之后的治疗紧急不良事件(AEs)和药物不良反应。结果:有684例患者的中期数据(中位年龄69.0岁;75.3%的女性;不实用的89.6%;9.8%持续/复发性)。利奥瓜特的中位治疗时间358天(范围2-1128天);中位剂量5.8毫克/天。 Prior use of an ERA in 29.8% of patients, PCA in 29.8%, PDE5i in 23.2% and balloon pulmonary angioplasty (BPA) in 27.2%. Concomitant ERA in 29.7%, PCA in 27.5%, PDE5i in 1.5%. AEs were reported in 188 patients (27.5%), drug-related AEs in 118 (17.3%; Table) and serious drug-related AEs in 15 (2.2%): 24 (3.5%) withdrew because of BPA and 44 (6.4%) because of AEs.Conclusions: The AE profile of riociguat in clinical practice in Japan appears consistent with clinical trials globally and in Japan. The most common AEs are consistent with the vasodilating action of riociguat. View this table:FootnotesCite this article as: European Respiratory Journal 2018 52: Suppl. 62, PA3054.This is an ERS International Congress abstract. No full-text version is available. Further material to accompany this abstract may be available at www.ers-education.org (ERS member access only). ER -