Sitaxsentan 300 mg increased peak VO(2) compared with placebo (+3.1%, p<0.01) in patients with pulmonary arterial hypertension, and both 100 mg and 300 mg doses improved 6-minute walk distance.
RCT (n=178)
Does sitaxsentan improve peak VO(2) and exercise capacity in patients with pulmonary arterial hypertension?
Sitaxsentan improves exercise capacity and hemodynamics in patients with pulmonary arterial hypertension, though the 300-mg dose is associated with an increased incidence of elevated aminotransferase levels.
p-value: p=<0.01
Sitaxsentan may benefit patients with pulmonary arterial hypertension by blocking the vasoconstrictor effects of endothelin-A while maintaining the vasodilator/clearance functions of endothelin-B receptors. Patients with pulmonary arterial hypertension that was idiopathic, related to connective tissue disease or congenital heart disease, were randomized to receive placebo (n = 60), sitaxsentan 100 mg (n = 55), or sitaxsentan 300 mg (n = 63) orally once daily for 12 weeks. The primary endpoint was change in peak VO(2) at Week 12. Secondary endpoints included 6-minute walk, New York Heart Association class, VO(2) at anaerobic threshold, VE per carbon dioxide production at anaerobic threshold, hemodynamics, quality of life, and time to clinical worsening. Although the 300-mg group increased peak VO(2) compared with placebo (+3.1%, p three times normal) was 3% for the placebo group, 0% for the 100-mg group, and 10% for the 300-mg group.
Barst et al. (Mon,) conducted a rct in Pulmonary arterial hypertension (n=178). Sitaxsentan vs. Placebo was evaluated on Change in peak VO(2) at Week 12 (p=<0.01). Sitaxsentan 300 mg increased peak VO(2) compared with placebo (+3.1%, p<0.01) in patients with pulmonary arterial hypertension, and both 100 mg and 300 mg doses improved 6-minute walk distance.
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