RESPITE: switching to riociguat in pulmonary arterial hypertension patients with inadequate response to phosphodiesterase-5 inhibitors.
RESPITE: switching to riociguat in pulmonary arterial hypertension patients with inadequate response to phosphodiesterase-5 inhibitors.
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DOI：
10.1183/13993003.02425-2016
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发表时间：
2017-09
期刊：
影响因子：
--
通讯作者：
Benza RL
中科院分区：
文献类型：
--
作者：
Hoeper MM;Simonneau G;Corris PA;Ghofrani HA;Klinger JR;Langleben D;Naeije R;Jansa P;Rosenkranz S;Scelsi L;Grünig E;Vizza CD;Chang M;Colorado P;Meier C;Busse D;Benza RL
一部分肺动脉高压（PAH）患者使用磷酸二酯酶-5抑制剂（PDE5i）不能达到治疗目标。RESPITE研究了这些患者从PDE5i切换到riociguat的安全性、可行性和益处。RESPITE是一项为期24周、开放标签、多中心、非对照研究。世界卫生组织（WHO）功能分类（FC） III， 6分钟步行距离（6MWD） 165-440 m，心脏指数<3.0 L·min - 1·m - 2，肺血管阻力>400 dyn·s·cm - 5的患者在接受riociguat调整至最大t.i.d 2.5 mg之前，接受1 - 3天PDE5i无治疗期。探索终点包括6MWD、WHO FC、脑钠肽n端原激素（NT-proBNP）和安全性的变化。在入组的61例患者中，51例（84%）完成了喘息。50例（82%）同时接受内皮素受体拮抗剂治疗。24周时，28例（54%）患者的平均±sd 6MWD增加了31±63 m， NT-proBNP下降了347±1235 pg·mL - 1， WHO FC改善。32例（52%）患者出现研究药物相关不良事件，10例（16%）患者出现严重不良事件（2例（3%）与研究药物相关，无PDE5i无治疗期）。6例患者（10%）出现临床恶化，包括2例死亡（与研究药物无关）。总之，选定的PAH患者可能从PDE5i切换到瑞西奎特中获益，但该策略需要进一步研究。对PDE5i反应不足的PAH患者改用瑞西奎特可改善运动能力和NT-proBNP http://ow.ly/e6xL30dXCgy
A proportion of pulmonary arterial hypertension (PAH) patients do not reach treatment goals with phosphodiesterase-5 inhibitors (PDE5i). RESPITE investigated the safety, feasibility and benefit of switching from PDE5i to riociguat in these patients. RESPITE was a 24-week, open-label, multicentre, uncontrolled study. Patients in World Health Organization (WHO) functional class (FC) III, with 6-min walking distance (6MWD) 165–440 m, cardiac index <3.0 L·min−1·m−2 and pulmonary vascular resistance >400 dyn·s·cm−5 underwent a 1–3 day PDE5i treatment-free period before receiving riociguat adjusted up to 2.5 mg maximum t.i.d. Exploratory end-points included change in 6MWD, WHO FC, N-terminal prohormone of brain natriuretic peptide (NT-proBNP) and safety. Of 61 patients enrolled, 51 (84%) completed RESPITE. 50 (82%) were receiving concomitant endothelin receptor antagonists. At week 24, mean±sd 6MWD had increased by 31±63 m, NT-proBNP decreased by 347±1235 pg·mL−1 and WHO FC improved in 28 patients (54%). 32 patients (52%) experienced study drug-related adverse events and 10 (16%) experienced serious adverse events (2 (3%) study drug-related, none during the PDE5i treatment-free period). Six patients (10%) experienced clinical worsening, including death in two (not study drug-related). In conclusion, selected patients with PAH may benefit from switching from PDE5i to riociguat, but this strategy needs to be further studied. Switching to riociguat in PAH patients with inadequate response to PDE5i improved exercise capacity and NT-proBNP http://ow.ly/e6xL30dXCgy
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DOI：
10.1038/nrd2030
发表时间：
2006-08
期刊：
Nature reviews. Drug discovery
影响因子：
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作者：
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10.1161/01.atv.0000168414.06853.f0
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