Vardenafil treatment for patients with pulmonary arterial hypertension: a multicentre, open-label study
Vardenafil treatment for patients with pulmonary arterial hypertension: a multicentre, open-label study
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DOI：
10.1136/hrt.2009.169417
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发表时间：
2009-09-15
期刊：
影响因子：
5.7
通讯作者：
Gao, W.
中科院分区：
文献类型：
--
作者：
Jing, Z-C;Jiang, X.;Gao, W.
背景资料：伐地那非（Vardenafil）是一种新型的磷酸二酯酶-5抑制剂，对肺动脉高压（PAH）有一定的治疗作用。目的：观察伐地那非治疗PAH的远期疗效。在45例PAH患者中开展了一项为期1年的多中心、开放标签研究，以确定伐地那非的长期安全性和疗效（前4周5 mg每日一次，然后5 mg每日两次），并与其他PAH活性治疗相比，对其每月购买成本进行初步评估。患者的临床特征、运动能力、WHO功能分级和血液动力学变量在基线和开始伐地那非治疗后3个月和至少9个月进行测量。在3个月和平均（SD）14（3）个月时（9-18）后续评估，6分钟步行距离较基线分别显著增加70.7（78.4）m（p < 0.001）和83.4（91.8）m（p < 0.001）。此外，平均持续时间>1年的伐地那非长期治疗也与血流动力学参数、WHO功能分级和血清尿酸浓度的改善相关。总体而言，伐地那非治疗耐受性良好。没有患者退出，由于不良事件，没有人死亡的过程中的study.Conclusion：长期治疗伐地那非耐受性良好，并持续有益的影响PAH，测量患者的运动能力，WHO功能分类和血液动力学参数。
Background: Vardenafil is a new phosphodiesterase-5 inhibitor that has shown some efficacy in the treatment of pulmonary arterial hypertension (PAH).Objective: To examine the long-term effects of vardenafil in patients with PAH.Methods: A multicentre, open-label study of 1-year's duration was undertaken in 45 patients with PAH to determine the long-term safety and efficacy of vardenafil (5 mg once daily for the first 4 weeks, then 5 mg twice daily) and make a preliminary assessment of its monthly acquisition cost compared with other PAH-active treatments. The patients' clinical features, exercise capacity, WHO functional class and haemodynamic variables were measured at baseline and at 3 and at least 9 months after initiating vardenafil treatment.Results: At the 3 months and a mean (SD) of 14 (3) months (range 9-18) follow-up assessments, the 6 min walking distance was significantly increased from baseline by 70.7 (78.4) m (p < 0.001) and 83.4 (91.8) m (p < 0.001), respectively. Furthermore, long-term treatment with vardenafil for a mean duration of >1 year was also associated with improvements in haemodynamic parameters, WHO functional class and serum uric acid concentrations. Overall, vardenafil treatment was well tolerated. No patients were withdrawn owing to adverse events and none died during the course of the study.Conclusion: Long-term treatment with vardenafil is well tolerated and has sustained beneficial effects on PAH, as measured by patients' exercise capacity, WHO functional class and haemodynamic parameters.