Sildenafil (Viagra™) approved for treatment of pulmonary arterial hypertension (PAH) as Revatio™


New York/Gießen. In a priority review the U.S. Food and Drug Administration (FDA) has approved Revatio (™) (sildenafil) as a treatment for pulmonary arterial hypertension (PAH). The FDA approval was based on the preceding experimental and clinical investigations, which were initiated and largely performed at the University of Giessen Lung Center (UGLC) and led to a worldwide multicenter study.

Pulmonary Hypertension (PH) is chronic and life-shortening vascular disease characterized by high pressure in the lung blood vessels leading to right heart failure. In a translational research effort realizing the "bench to bedside" approach, a team of physicians led by Prof. Friedrich Grimminger and Dr. Ardeschir Ghofrani organized the "Giessen Everest Experiment" with the aim to further investigate the therapeutic potential of sildenafil (Viagra™) in humans: The changes observed in healthy mountaineers simulate disease processes in patients suffering from chronic lung diseases. This high altitude study clearly documented the selective pulmonary vasodilatory effect of sildenafil. The substance reduces pulmonary hypertension, improves gas exchange and increases exercise capacity. Further clinical studies in Giessen in patients suffering from different forms of PH (adults, children and infants) have confirmed these results and lead to an international multicenter study. The results of this large randomized, double-blind, placebo-controlled study were first presented by Giessen scientists at the World Conference of the American College of Chest Physicians in September 2004. The group published the results of their studies in pulmonary hypertension in renowned scientific journals such as "Nature Medicine", "Annals of Internal Medicine", Lancet" and "New England Journal of Medicine".

Source: Eurekalert & others

Last reviewed: By John M. Grohol, Psy.D. on 21 Feb 2009
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