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.