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Riociguat treatment in patients with chronic thromboembolic pulmonary hypertension: Final safety data from the EXPERT registry
Respiratory Medicine ( IF 4.3 ) Pub Date : 2020-11-12 , DOI: 10.1016/j.rmed.2020.106220
Hossein-Ardeschir Ghofrani 1 , Miguel-Angel Gomez Sanchez 2 , Marc Humbert 3 , David Pittrow 4 , Gérald Simonneau 5 , Henning Gall 1 , Ekkehard Grünig 6 , Hans Klose 7 , Michael Halank 8 , David Langleben 9 , Repke J Snijder 10 , Pilar Escribano Subias 11 , Lisa M Mielniczuk 12 , Tobias J Lange 13 , Jean-Luc Vachiéry 14 , Hubert Wirtz 15 , Douglas S Helmersen 16 , Iraklis Tsangaris 17 , Joan A Barberá 18 , Joanna Pepke-Zaba 19 , Anco Boonstra 20 , Stephan Rosenkranz 21 , Silvia Ulrich 22 , Regina Steringer-Mascherbauer 23 , Marion Delcroix 24 , Pavel Jansa 25 , Iveta Šimková 26 , George Giannakoulas 27 , Jens Klotsche 28 , Evgenia Williams 29 , Christian Meier 29 , Marius M Hoeper 30 ,
Affiliation  

Objective

The soluble guanylate cyclase stimulator riociguat is approved for the treatment of adult patients with pulmonary arterial hypertension (PAH) and inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension (CTEPH) following Phase 3 randomized trials. The EXPosurE Registry RiociguaT in patients with pulmonary hypertension (EXPERT) study was designed to monitor the long-term safety of riociguat in clinical practice.

Methods

EXPERT was an international, multicenter, prospective, uncontrolled, non-interventional cohort study of patients treated with riociguat. Patients were followed for at least 1 year and up to 4 years from enrollment or until 30 days after stopping riociguat treatment. Primary safety outcomes were adverse events (AEs) and serious adverse events (SAEs) coded using Medical Dictionary for Regulatory Activities preferred terms and System Organ Classes version 21.0, collected during routine clinic visits and collated via case report forms.

Results

In total, 956 patients with CTEPH were included in the analysis. The most common AEs in these patients were peripheral edema/edema (11.7%), dizziness (7.5%), right ventricular (RV)/cardiac failure (7.7%), and pneumonia (5.0%). The most common SAEs were RV/cardiac failure (7.4%), pneumonia (4.1%), dyspnea (3.6%), and syncope (2.5%). Exposure-adjusted rates of hemoptysis/pulmonary hemorrhage and hypotension were low and comparable to those in the long-term extension study of riociguat (Chronic Thromboembolic Pulmonary Hypertension Soluble Guanylate Cyclase–Stimulator Trial [CHEST-2]).

Conclusion

Data from EXPERT show that in patients with CTEPH, the safety of riociguat in routine practice was consistent with the known safety profile of the drug, and no new safety concerns were identified.



中文翻译:

慢性血栓栓塞性肺动脉高压患者的 Riociguat 治疗:来自 EXPERT 注册的最终安全性数据

客观的

可溶性鸟苷酸环化酶刺激剂 riociguat 在 3 期随机试验后被批准用于治疗患有肺动脉高压 (PAH) 和无法手术或持续/复发性慢性血栓栓塞性肺动脉高压 (CTEPH) 的成年患者。EXPosure Registry RiociguaT 在肺动脉高压患者中的应用 (EXPERT) 研究旨在监测 riociguat 在临床实践中的长期安全性。

方法

EXPERT 是一项国际、多中心、前瞻性、非对照、非干预性队列研究,研究对象为使用利奥西呱治疗的患者。从入组开始或直至停止利奥西呱治疗后 30 天,对患者进行了至少 1 年至 4 年的随访。主要安全性结果是不良事件 (AE) 和严重不良事件 (SAE),这些不良事件 (AE) 和严重不良事件 (SAE) 使用医学词典进行监管活动首选术语和系统器官分类 21.0 版进行编码,在常规临床访问期间收集并通过病例报告表进行整理。

结果

总共有 956 名 CTEPH 患者被纳入分析。这些患者中最常见的 AE 是外周水肿/水肿 (11.7%)、头晕 (7.5%)、右心室 (RV)/心力衰竭 (7.7%) 和肺炎 (5.0%)。最常见的 SAE 是 RV/心脏衰竭 (7.4%)、肺炎 (4.1%)、呼吸困难 (3.6%) 和晕厥 (2.5%)。咯血/肺出血和低血压的暴露调整率较低,与 riociguat 的长期扩展研究(慢性血栓栓塞性肺动脉高压可溶性鸟苷酸环化酶刺激剂试验 [CHEST-2])中的发生率相当。

结论

来自 EXPERT 的数据显示,在 CTEPH 患者中,riociguat 在常规实践中的安全性与该药物的已知安全性一致,未发现新的安全性问题。

更新日期:2020-11-12
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