Ty - jour t1 -专利加:riociguat联合西地那非治疗肺动脉高压的盲法、随机和扩展研究JF -欧洲呼吸杂志JO - Eur Respir J SP - 1314 LP - 1322 DO - 10.1183/09031936.00105914 VL - 45 IS - 5 AU - Galiè， Nazzareno AU - Müller, Katharina AU - Scalise, Andrea-Viviana AU - Grünig，Ekkehard Y1 - 2015/05/01 UR - //www.qdcxjkg.com/content/45/5/1314.abstract N2 - PATENT PLUS评估了riociguat联合西地那非治疗肺动脉高压患者的安全性和有效性。接受西地那非(每日3次，20mg)的患者被随机分配到安慰剂组或riociguat组(每日3次，最高2.5 mg)，持续12周。主要终点为给药后4小时内仰卧位收缩压(SBP)较基线的最大变化。次要目标包括额外的血压、心率和探索性疗效变量，以及安全性。患者可进入长期延长治疗(LTE)，所有患者均接受riociguat +西地那非治疗。在riociguat组(n=12)之间，4 h内仰卧位收缩压与基线的最大变化无差异(平均±sd基线:-20.2±15.3 mmHg;第12周:-20.7±18.0 mmHg)和安慰剂组(n=6)(分别为-7.6±3.9和-20.2±12.9 mmHg)。站立时收缩压和仰卧位或站立时舒张压的变化也无差异。 Combination therapy showed no favourable effects on exploratory clinical parameters, including haemodynamics and exercise capacity. In the LTE, there were high rates of discontinuation due to hypotension and three (18%) deaths (not considered study drug-related by the investigator). There were potentially unfavourable safety signals with sildenafil plus riociguat and no evidence of a positive benefit/risk ratio. Concomitant use of riociguat with phosphodiesterase-5 inhibitors is therefore contraindicated. Sildenafil+riociguat in PAH: no evidence of a positive benefit/risk ratio and potentially unfavourable safety signals http://ow.ly/Hbmfh ER -