The efficacy and safety of sildenafil in Chinese patients with pulmonary arterial hypertension.
Sildenafil has been suggested to be a cost-effective treatment for pulmonary arterial hypertension (PAH). On account of the lack of data confirming its benefit in PAH patients, sildenafil has not been adopted in China for the treatment of PAH. The purpose of this study was to evaluate the efficacy, safety and 1-year survival of Chinese patients with PAH treated with sildenafil. Sixty Chinese patients with PAH were enrolled in this preliminary study. Their 6-min walk distance, WHO functional class and hemodynamic parameters (such as right atrial pressure, pulmonary arterial pressure, cardiac index and pulmonary vascular resistance) at both baseline and 16 weeks after initiation of sildenafil treatment were recorded. In addition, 1-year overall survival was assessed in this cohort. The 6-min walk distance improved from 392.13+/-91.35 to 467.22+/-80.38 m during the course of treatment (P<0.001). There was a significant decrease in the mean pulmonary vascular resistance (15.28+/-8.12-14.99+/-7.88 Woods units; P=0.02) and a significant increase in the mean cardiac index (2.39+/-0.90-2.75+/-0.92 l/min/m(2), P=0.006) of the included patients at 16 weeks. The mean systemic oxygen saturation improved significantly at 16 weeks (91.44+/-7.54%-94.11+/-4.28%; P=0.002). No serious adverse reactions were reported. The Kaplan-Meier analysis showed that the 1-year survival rate improved significantly in the sildenafil-treated cohort compared with predicted survival (94.7% compared with 63.3%, P=0.03). In conclusion, sildenafil may be a safe and effective treatment for Chinese PAH patients. Sildenafil, when added to conventional therapy, was associated with improvements in exercise capacity, hemodynamic parameters and overall survival in a cohort of Chinese patients with PAH.
Xu
Xi-Qi
XQ
Department of Pulmonary Circulation, Shanghai Pulmonary Hospital, Tongji University Medical School, Shanghai, China.
Jing
Zhi-Cheng
ZC
Zhang
Jin-Hu
JH
Wu
Yan
Y
Wang
Yong
Y
Jiang
Xin
X
Wang
Zhi-Xing
ZX
Sun
Yin-Guang
YG
Pu
Jie-Lin
JL
Yang
Yue-Jin
YJ
D000328:Adult; D015415:Biomarkers; D006328:Cardiac Catheterization; D015444:Exercise / Q000502:physiology; D005080:Exercise Test; D005260:Female; D006439:Hemodynamics / Q000187:drug effects; D006801:Humans; D006976:Hypertension, Pulmonary / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D010879:Piperazines / Q000627:therapeutic use*; D011652:Pulmonary Circulation / Q000187:drug effects; D011687:Purines / Q000627:therapeutic use; D000068677:Sildenafil Citrate; D013450:Sulfones / Q000627:therapeutic use*; D013534:Survival; D014665:Vasodilator Agents / Q000627:therapeutic use*
D015415:Biomarkers; D010879:Piperazines; D011687:Purines; D013450:Sulfones; D014665:Vasodilator Agents; D000068677:Sildenafil Citrate