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Sildenafil of Mixed Value in Idiopathic Pulmonary Fibrosis

Last Updated: May 18, 2010.

In patients with advanced idiopathic pulmonary fibrosis, treatment with sildenafil does not significantly increase walking distance compared to placebo but may be associated with some symptomatic improvements, according to a study published online May 18 in the New England Journal of Medicine to coincide with presentation at the American Thoracic Society (ATS) International Conference in New Orleans.

TUESDAY, May 18 (HealthDay News) -- In patients with advanced idiopathic pulmonary fibrosis, treatment with sildenafil does not significantly increase walking distance compared to placebo but may be associated with some symptomatic improvements, according to a study published online May 18 in the New England Journal of Medicine to coincide with presentation at the American Thoracic Society (ATS) International Conference in New Orleans.

David Zisman, M.D., of the Sansum Clinic in Santa Barbara, Calif., and colleagues randomly assigned 180 patients to receive either sildenafil or placebo for 12 weeks. In a second 12-week period, all participants received sildenafil in an open-label evaluation.

The researchers found that there was no significant difference in the primary outcome -- the proportion of patients achieving an increase in six-minute walk distance of at least 20 percent -- between the sildenafil group and placebo group. But they found that the sildenafil group achieved small but significant improvements in such secondary outcomes as arterial oxygenation, carbon monoxide diffusion capacity, degree of dyspnea, and quality of life. They also found that serious adverse events were similar in the two groups.

"Although this study did not meet its pre-specified primary outcome and the therapeutic efficacy of sildenafil is far from established, our data provide the clinical equipoise needed to conduct further trials involving patients with advanced idiopathic pulmonary fibrosis," Zisman and colleagues conclude. "While such trials are being designed and implemented, our finding that sildenafil was associated with symptomatic improvement may be of value to patients with advanced idiopathic pulmonary fibrosis."

Pfizer donated sildenafil and placebo for the study, and Masimo donated pulse oximeters.

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