Identifying potential parameters associated with response to switching from a PDE5i to riociguat in RESPITE
Identifying potential parameters associated with response to switching from a PDE5i to riociguat in RESPITE
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DOI：
10.1016/j.ijcard.2020.05.044
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发表时间：
2020-10-15
影响因子：
3.5
通讯作者：
Hoeper, Marius M.
中科院分区：
文献类型：
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作者：
Benza, Raymond L.;Corris, Paul A.;Hoeper, Marius M.
背景资料：EQUIPITE评价了对5型磷酸二酯酶抑制剂（PDE 5i）反应不充分的肺动脉高压患者，这些患者转换为利奥西呱。这种事后分析评估响应这一开关参数与临床improvement.Methods：ESTAITE是一个为期24周的，不受控制的试点研究（n = 61）。比较应答者之间的功能、血流动力学和心功能参数、REVEAL风险评分（RRS）和生物标志物的差异（无临床恶化，世界卫生组织功能I/II级，并且在第24周时6分钟步行距离改善>= 30 m）和无应答者。在51名完成ESTITE的患者（84%）中，16名（31%）达到了应答者终点。在基线时，应答者和非应答者的N末端脑钠肽前体（NT-proBNP）、生长/分化因子15（GDF-15）和RRS存在显著差异，而血流动力学或心功能无差异。在第24周，应答者的肺动脉顺应性、肺血管阻力和平均肺动脉压显著改善，而非应答者无显著变化。结论：NT-proBNP、GDF-15和RRS被确定为从PDE 5i转换为利奥西呱的患者的反应的潜在预测因子。需要进一步的前瞻性对照研究来证实这些参数与反应的关联。(c)2020作者由Elsevier B. V.发布。这是CC BY-NC-ND许可证下的开放获取文章（http：//creativecommons.org/licenses/by-nc-nd/4.0/）。
Background: RESPITE evaluated patients with pulmonary arterial hypertension and an inadequate response to phosphodiesterase type 5 inhibitors (PDE5i) who switched to riociguat. This post hoc analysis assessed response to this switch in parameters associated with clinical improvement.Methods: RESPITE was a 24-week, uncontrolled pilot study (n = 61). Differences in functional, hemodynamic, and cardiac function parameters, REVEAL risk score (RRS), and biomarkers were compared between responders (free from clinical worsening, World Health Organization functional class I/II, and >= 30 m improvement in 6-min walking distance at Week 24) and non-responders.Results: Of 51 patients (84%) completing RESPITE, 16 (31%) met the responder endpoint. At baseline, there were significant differences between responders and non-responders in N-terminal prohormone of brain natriuretic peptide (NT-proBNP), growth/differentiation factor 15 (GDF-15), and RRS, whereas there were no differences in hemodynamics or cardiac function. At Week 24, responders had significant improvements in pulmonary arterial compliance, pulmonary vascular resistance, and mean pulmonary arterial pressure, while non-responders showed no significant change. Cardiac efficiency and stroke volume index significantly improved irrespective of responder status.Conclusions: NT-proBNP, GDF-15, and RRS were identified as potential predictors of response in patients switching from PDE5i to riociguat. Further prospective controlled studies are needed to confirm the association of these parameters with response. (c) 2020 The Authors. Published by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http:// creativecommons.org/licenses/by-nc-nd/4.0/).