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| |  Sildenafil Shows Promise for Treating Pulmonary Arterial Hypertension Due to Connective Tissue Disorder: Presented at ACR By Paula Moyer SAN DIEGO, CA -- November 18, 2005 -- Sildenafil (Revatio) is effective in treating pulmonary arterial hypertension (PAH) as a complication of connective tissue disease, investigators reported here at the American College of Rheumatology Annual Scientific Meeting (ACR). Sildenafil is approved for the treatment of PAH, and its use in the setting of connective tissue disease would expand the indication, according to the researchers. The drug, under the name Viagra, is widely used to treat erectile dysfunction. In both cases, the drug functions as a vasodilator. In a study, researchers demonstrated that oral sildenafil, taken in 20-mg doses 3 times a day, can also improve functioning in patients with PAH due to connective tissue disease. "Therefore, sildenafil may prove to be an effective treatment for a hard-to-manage condition," said David Badesch, MD, professor of medicine, University of Colorado Health Sciences Center, and clinical director, Pulmonary Hypertension Center, Denver, Colorado. Pulmonary arterial hypertension often occurs in connective tissue diseases such as scleroderma, lupus, and rheumatoid arthritis, and is progressive and can be life-threatening. To determine if sildenafil would provide benefit in patients with connective tissue disease, Dr. Badesch and colleagues analyzed results on such patients who had participated in a previous study of the drug. The 12-week study had randomized 278 patients with PAH in double-blind fashion to placebo or to 1 of 3 doses of sildenafil 3 times daily (20 mg, 40 mg, or 80 mg). For their analysis, Dr. Badesch and colleagues assessed the results of treatment in the 84 patients who had PAH due to connective tissue disease. They assessed the following parameters: exercise capacity (6-minute walk), mean pulmonary arterial pressure, cardiac output, pulmonary vascular resistance, and change in functional class by World Health Organization (WHO) criteria. At baseline, 32 patients (38%) were in WHO functional class II and 51 (61%) were in functional class III; one patient (1%) was in functional class IV. At the end of the study, patients on placebo had an average decrease of 13 m. Patients on 20 mg of sildenafil increased their 6-minute walk distance an average of 42 m; those in the 40-mg and 80-mg groups increased their walk distance by 36 m and 15 m, respectively (P < .05 for 20 mg and 40 mg compared with placebo). Mean pulmonary arterial pressure decreased an average of 4.6 mm Hg in the 20-mg group, 2.8 mm Hg in the 40-mg group, and 3.2 mm Hg in the 80-mg group; the placebo patients experienced an average increase of 1.4 mm Hg. Pulmonary vascular resistance decreased an average of 243 dynes/second/cm2 in sildenafil patients compared with placebo patients, who had an average decrease of 19 dynes/second/cm2 (P < .05). The decreases in the other 2 sildenafil dosage groups were not statistically significant. There was a WHO functional class improvement in 5% of placebo patients, compared with 29% to 42% of sildenafil-treated patients. The investigators concluded that sildenafil may have similar benefits for PAH secondary to connective tissue disease as it does in other settings. The study was funded by Pfizer, which manufactures Revatio.
[Presentation title: Sildenafil Improves Exercise Ability and Hemodynamics in Patients With Pulmonary Arterial Hypertension Associated With Connective Tissue Disease. Abstract 693]
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