Key result
Long-term vardenafil therapy for 3 months significantly decreased pulmonary vascular resistance from 838.2 to 500.6 dyn·s/cm5 in patients with pulmonary hypertension.
Why the study?
Does oral vardenafil improve hemodynamics and functional capacity in patients with pulmonary hypertension?
Case Report (n=5)
No
Does oral vardenafil improve hemodynamics and functional capacity in patients with pulmonary hypertension?
Absolute Event Rate: 500.6% vs 838.2%
p-value: p=<0.05
Long-term oral vardenafil therapy safely improves pulmonary hemodynamics and reduces BNP levels in patients with pulmonary hypertension.
Hypothesis-generating for vardenafil in pulmonary hypertension; leaves open its role pending controlled trials.
The phosphodiesterase-5 (PDE-5) inhibitor, sildenafil, has been reported to produce sustained pulmonary vasodilatation in patients with pulmonary hypertension (PH). Recently, vardenafil, a more potent and selective PDE-5 inhibitor than sildenafil, has been approved for the treatment of erectile dysfunction. However, the long-term effects of oral vardenafil in patients with PH are unknown. We studied five consecutive patients with PH; one with primary pulmonary hypertension, two with chronic pulmonary thromboembolism, one with Eisenmenger syndrome (ventricular septal defect) and one with secondary pulmonary hypertension after a ventricular septal defect closure operation. In an acute hemodynamic trial, vardenafil (5 mg) significantly decreased both the pulmonary vascular resistance (PVR) and systemic vascular resistance (SVR) with an increase in cardiac output. In a chronic hemodynamic trial, the maintenance dose of vardenafil (10 to 15 mg) for 3 months significantly decreased the PVR, but not the SVR, with a 20.7% reduction of the PVR/ SVR ratio. Plasma brain natriuretic peptide (BNP) levels were also significantly decreased after 3 months. This pilot study demonstrates that long-term oral vardenafil therapy may be a safe and effective treatment for patients with PH.
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Aizawa et al. (2006) conducted a case report in Pulmonary Hypertension (n=5). Vardenafil vs. Baseline was evaluated on Pulmonary vascular resistance (PVR) at 3 months (p=<0.05). Long-term vardenafil therapy for 3 months significantly decreased pulmonary vascular resistance from 838.2 to 500.6 dyn·s/cm5 in patients with pulmonary hypertension.
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