Vardenafil significantly increased 6-minute walking distance by 69 m (P<0.001) and reduced clinical worsening events compared to placebo (2.3% vs 20%; HR 0.105, 95% CI 0.012-0.938).
RCT (n=66)
Double-blind
2:1
Does vardenafil improve 6-minute walking distance and clinical outcomes in Chinese patients with pulmonary arterial hypertension?
Vardenafil significantly improves functional capacity, hemodynamics, and reduces clinical worsening events in patients with pulmonary arterial hypertension.
Effect estimate: HR 0.105 (95% CI 0.012-0.938)
Absolute Event Rate: 2.3% vs 20%
p-value: p=0.044
Abstract Rationale Although the phosphodiesterase type 5 inhibitors sildenafil and tadalafil have demonstrated efficacy in patients with pulmonary arterial hypertension (PAH), monotherapy with these agents has not been conclusively shown to reduce clinical worsening events. Objectives To evaluate the safety and efficacy of the phosphodiesterase type 5 inhibitor vardenafil in Chinese patients with PAH. Methods In a randomized, double-blind, placebo-controlled study, 66 patients with PAH were randomized 2:1 to vardenafil (5 mg once daily for 4 wk then 5 mg twice daily; n = 44) or placebo (n = 22) for 12 weeks. Patients completing this phase were then treated with open-label vardenafil (5 mg twice daily) for a further 12 weeks. Measurements and Main Results At Week 12, the mean placebo-corrected 6-minute walking distance was increased with vardenafil (69 m; P 0.001), and this improvement was maintained for at least 24 weeks. Vardenafil also increased the mean placebo-corrected cardiac index (0.39 L·min−1·m−2; P = 0.005) and decreased mean pulmonary arterial pressure and pulmonary vascular resistance (−5.3 mm Hg, P = 0.047; −4.7 Wood U, P = 0.003; respectively) at Week 12. Four patients in the placebo group (20%) and one in the vardenafil group (2.3%) had clinical worsening events (hazard ratio 0.105; 95% confidence interval, 0.012–0.938; P = 0.044). Vardenafil was associated with only mild and transient adverse events. Conclusions Vardenafil is effective and well tolerated in patients with PAH at a dose of 5 mg twice daily.
Jing et al. (Sun,) conducted a rct in pulmonary arterial hypertension (PAH) (n=66). vardenafil vs. placebo was evaluated on clinical worsening events (HR 0.105, 95% CI 0.012-0.938, p=0.044). Vardenafil significantly increased 6-minute walking distance by 69 m (P<0.001) and reduced clinical worsening events compared to placebo (2.3% vs 20%; HR 0.105, 95% CI 0.012-0.938).