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Published on 11/16/2005 in the Prospect News Biotech Daily.

Pfizer says study finds Revatio effective in treating pulmonary arterial hypertension

New York, Nov. 16 - Pfizer Inc. said a study in the current issue of the New England Journal of Medicine shows Revatio (sildenafil citrate) to be effective in treating the symptoms of pulmonary arterial hypertension in adults.

Sildenafil citrate is the same active ingredient found in Viagra.

The double-blind, placebo-controlled study of 278 patients with symptomatic pulmonary arterial hypertension showed Revatio significantly improved exercise capacity, hemodynamics and functional classification (a measure of illness severity). Patients in the study received 20, 40, or 80 mg of sildenafil three times daily or a placebo. Similar efficacy was observed for each dose.

At the end of a one year, open-label extension study, 95% of patients were still alive. Patients also maintained their improvement in the six-minute walk distance at one year (51-meter improvement, compared with a 48-meter gain at week 12).

The 20 mg dose of Revatio was approved this year by regulatory authorities in the United States and Europe for the treatment of pulmonary arterial hypertension in adults.

Pulmonary arterial hypertension is a rare and fatal disorder characterized by dangerously high pressure in the blood vessels that lead from the heart to the lungs. Symptoms include fatigue, breathlessness and dizziness, which often reduces or prevents normal daily activities for patients. Pulmonary arterial hypertension is estimated to affect approximately 100,000 people worldwide, and is more likely to affect women between the ages of 20 and 40.

Pfizer is a New York-based pharmaceutical company.


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