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Clinical Investigations: PULMONARY HYPERTENSION |

Clinical Efficacy of Sitaxsentan, an Endothelin-A Receptor Antagonist, in Patients With Pulmonary Arterial Hypertension*: Open-Label Pilot Study

Robyn J. Barst, MD; Stuart Rich, MD, FCCP; Allison Widlitz, MS, PA; Evelyn M. Horn, MD; Vallerie McLaughlin, MD; Joyce McFarlin, RN
Author and Funding Information

*From the Department of Pediatrics (Dr. Barst and Ms. Widlitz) and Medicine (Dr. Horn), Columbia University, College of Physicians and Surgeons, New York, NY; and Department of Medicine (Drs. Rich and McLaughlin, and Ms. McFarlin), Rush University Medical College, Chicago, IL.

Correspondence to: Robyn J. Barst, MD, Babies Hospital, 3959 Broadway, BH-262 North, New York, NY 10032



Chest. 2002;121(6):1860-1868. doi:10.1378/chest.121.6.1860
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Study objectives: To evaluate the safety and efficacy of sitaxsentan, an endothelin-A receptor antagonist, in a 12-week, open-label trial of patients with pulmonary arterial hypertension (PAH).

Patients: Six children and 14 adults with New York Heart Association (NYHA) functional class II, III, or IV primary pulmonary hypertension or PAH associated with either congenital systemic-to-pulmonary shunts or collagen vascular disease were enrolled.

Measurements: Sitaxsentan was administered orally at 100 to 500 mg bid for 12 weeks. Cardiopulmonary hemodynamics via cardiac catheterization were obtained at baseline and week 12. Six-minute walk test distance was measured at baseline, week 6, and week 12.

Results: Sitaxsentan treatment resulted in significant improvement in exercise capacity as assessed by the 6-min walk distance (baseline [mean ± SD], 466 ± 132 m; week 12, 515 ± 141 m, n = 20, p = 0.006). Mean pulmonary artery pressure and pulmonary vascular resistance index also improved (63 ± 20 to 52 ± 22 mm Hg, n = 17, p = 0.0002; and 20 ± 11 to 14 ± 13 U × m2, n = 17, p = 0.008, respectively). Serious adverse events included two cases of acute hepatitis (fatal in one patient).

Conclusions: Patients with NYHA functional class II, III, or IV PAH showed a significant improvement in exercise capacity and cardiopulmonary hemodynamics over a 12-week period of treatment with sitaxsentan, an endothelin-A receptor antagonist. Further investigation is warranted to evaluate the safety and efficacy of sitaxsentan in patients with PAH.

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