According to the results of a small open-label study conducted in China, long-term vardenafil therapy may be beneficial in patients with pulmonary arterial hypertension (PAH).

The authors note that the efficacy and safety of long-term vardenafil therapy in patients with PAH has so far only been addressed in case reports.  This study included 45 patients with PAH (idiopathic, associated with connective tissue disease and congenital heart disease, or portopulmonary hypertension) who were treated at one of five pulmonary vascular or cardiovascular centres in China during October 2006 to January 2008.  All had stable WHO functional class II to IV disease, a mean pulmonary artery pressure (mPAP) >30 mmHg and a maximum 6-minutes walking distance (6MWD) of 550 metres at entry (no lower limit for inclusion).  Patients were treated with vardenafil 5mg daily orally for one month, after which the dose was increased to 5mg BD according to tolerability.  No vasodilators other than vardenafil were permitted within three months prior to, or during, the study.

The 6MWD was increased from baseline by 70.7 ± 78.4 metres (p<0.0001) at 3 months and 83.4 ±91.8 metres (p<0.0001) at the final assessment (mean duration of 14 ± 3 months; n=20).  Statistically significant improvements were seen in a number of haemodynamic variables assessed (e.g. mPAP: mean -7.7 mmHg; pulmonary vascular resistance: mean -6.1 Wood units).  The most common adverse events reported included flushing (60%) and headache (26.7%); the majority were mild and no patient discontinued therapy early due to adverse events. 

The authors conclude that their study “has demonstrated that vardenafil may improve both exercise tolerance and pulmonary vascular haemodynamic parameters in patients with PAH.”