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| |  ACR: Promising Results for Investigative Sitaxsentan in Treating Rheumatologic Diseases By Bruce Sylvester SAN ANTONIO, TEXAS -- October 20, 2004 -- Sitaxsentan, an investigative treatment for pulmonary hypertension, may offer improved quality of life for people diagnosed with scleroderma, lupus, and other connective tissue diseases (CTD) as well, according to phase 3 findings in the Sitaxsentan to Relieve Impaired Exercise (STRIDE-1) Trial. "Sitaxsentan subjects showed significant improvements in 6-minute walk distance, and there was improved cardiac index and pulmonary vascular resistance among subjects with pulmonary hypertension related to connective tissue disease," said lead investigator Vallerie McLaughlin, MD, associate professor of medicine, University of Michigan School of Medicine, Ann Arbor, Michigan. Dr. McLaughlin made her report here today at a press conference at the 68th Annual Scientific Meeting of the American College of Rheumatology. Dr. McLaughlin and colleagues conducted a multicenter, randomized, double-blind, placebo-controlled trial of the once-daily oral sitaxsentan, an endotheline-receptor antagonist. Sitaxsentan blocks the action of endotheline, a significant blood-vessel constrictor often elevated in patients with pulmonary hypertension. Researchers enrolled 178 patients with pulmonary hypertension for this 12-week trial. Forty-two of these patients had pulmonary hypertension related to a CTD. Clinicians randomized patients to either 100 mg or 300 mg dosage of sitaxsentan or placebo over a 12-week period. After 12 weeks, the patients treated with sitaxsentan increased in the 6-minute walk by 58 meters (P = 0.0274) compared with their 6-minute walk tests at baseline. In addition, 24% of patients in the sitaxsentan group improved by 1 class on the New York Health Association (NYHA) functional cardiology classification compared with 11% of the placebo patients. The researchers pooled data from the 100-mg and 300-mg groups due to similar treatment effects, and conducted a post hoc analysis to determine the effect of sitaxsentan on the 42 patients with pulmonary hypertension related to CTD. "The possibility of having an effective…oral, once-daily therapy could be a major advance," Dr. McLaughlin concluded.
[Presentation title: Sitaxsentan Improves 6MW in Patients With Pulmonary Arterial Hypertension (PAH) Related to Connective-Tissue Diseases (CTD). Abstract 1852]
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