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Sitaxsentan Therapy for Pulmonary Arterial Hypertension

Columbia University College of Physicians & Surgeons, New York, New York; Sir Mortimer B. Davis Jewish General Hospital, Montreal, Canada; Harbor-University of California at Los Angeles Medical Center, Torrance; University of Southern California, Los Angeles, California; Rush-Presbyterian-St. Luke's Medical Center, Chicago, Illinois; Rhode Island Hospital, Providence, Rhode Island; Duke University Medical Center, Durham, North Carolina; Vanderbilt University Hospital, Nashville, Tennessee; University of Wisconsin Medical Center, Milwaukee, Wisconsin; ICOS Corporation, Bothell, Washington; Baylor College of Medicine; and Encysive Pharmaceuticals, Houston, Texas

Correspondence and requests for reprints should be addressed to Robyn J. Barst, M.D., Columbia University College of Physicians & Surgeons, 3959 Broadway, BHN 2-255, New York, NY 10032-1551. E-mail: rjb3{at}columbia.edu

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 O₂ at Week 12. Secondary endpoints included 6-minute walk, New York Heart Association class, O₂ at anaerobic threshold, E per carbon dioxide production at anaerobic threshold, hemodynamics, quality of life, and time to clinical worsening. Although the 300-mg group increased peak O₂ compared with placebo (+3.1%, p < 0.01), none of the other endpoints derived from cardiopulmonary exercise testing were met. However, both the 100-mg dose and the 300-mg dose, compared with placebo, increased 6-minute walk distance (100 mg: +35 m, p < 0.01; 300 mg: +33 m, p < 0.01); functional class, cardiac index, and pulmonary vascular resistance also improved (p < 0.02 for each parameter at both doses). The incidence of elevated aminotransferase values (> three times normal) was 3% for the placebo group, 0% for the 100-mg group, and 10% for the 300-mg group.

Key Words: endothelins • exercise • hypertension, pulmonary • pulmonary heart disease

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