Background: Bosentan (an oral dual endothelin receptor antagonist) improves symptoms and cardiac hemodynamics and reduces clinical worsening in patients with pulmonary arterial hypertension (PAH). The VITAL study assessed the effect of bosentan on quality of life in patients with WHO Functional Class III or IV PAH (idiopathic or associated with connective tissue diseases).
Methods: Quality of life was assessed prospectively using the MOS SF-36 and AQOL questionnaires. Baseline readings and scores at 3 and 6 months were collected, in addition to other efficacy and safety data.
Results: Among the 177 study patients, SF-36 scores were significantly improved at 3 months in the domains of physical functioning (27.3 to 34.8; p < 0.0001), role-physical (16.6 to 30.9; p < 0.0001), vitality (35.2 to 41.1; p = 0.0003), social functioning (48.0 to 58.6; p < 0.0001), mental health (64.2 to 72.0; p = 0.005) and role-emotional (44.8 to 58.1; p = 0.001). Improvements were seen in all etiologic sub-groups and were maintained in patients who remained on bosentan. An improvement in AQOL measures at 3 months was also noted for patients with baseline WHO Functional Class III.
Conclusions: Bosentan significantly improves quality of life in patients with idiopathic PAH or PAH associated with connective tissue diseases.