By Ed Susman
Doctor's Guide

Treatment of pulmonary arterial hypertension (PAH) with sildenafil significantly improves several quality-of-life measures and walking distance in patients, researchers reported here today at the American Thoracic Society (ATS) 2010 International Conference.

"The positive relationship between exercise capacity and functional health and well-being in patients with pulmonary arterial hypertension suggests the value of developing generic and disease-specific measures for inclusion in clinical trials to fully characterise and quantify the health-related benefits of treatment," said Marko Mychaskiw, PhD, Pfizer, Inc., New York, New York.

Dr. Mychaskiw and colleagues pooled data from 2 clinical trials in which different doses of sildenafil were used to treat 340 patients who were compared with outcomes among 203 patients who were assigned placebo treatments in the studies.

"In patients treated with sildenafil, improvements were observed in the 6-minute walk distance test [6MWT] and in the Short Form-36 [SF-36] domains of General Health and Physical Functioning," he said during a poster presentation.

In the 12-week study, the mean placebo-corrected improvement in the 6MWT was 45.3 metres for patients taking the 20-mg dose of sildenafil, 46.1 metres among those on the 40-mg dose of sildenafil, and 49.7 metres among those on the 80-mg dose of sildenafil. In the 16-week study in which the sildenafil outcomes were pooled the mean placebo-corrected improvement was 26 metres. All those differences were statistically significant (P < .001), Dr. Mychaskiw reported.

He also reported that in the SF-36 tests, statistically significant changes in the 12-week study from baseline were observed for all doses of sildenafil in the Physical Function domain; and for the 40- and 80-mg doses of sildenafil in the General Health domain. In the 16-week study, he reported that there were significant improvements in the Physical Function domain, General Health domain, Vitality domain, Social Function domain, and Mental Health domain. There were no domains in which placebo was statistically significant when compared with baseline.

More than 70% of the patients enrolled in the trial were women, reflecting the gender differences in the disease. The average age of the participants was about 49 years. More than 80% of the patients enrolled in the studies were white. Most of the patients were diagnosed with idiopathic pulmonary arterial hypertension.

Funding for this study was provided by Pfizer, Inc.

[Presentation title: Evaluation of Sildenafil Treatment on Functional Health Status in Patients With Pulmonary Arterial Hypertension. Publication Page: A3336]

Source : http://www.docguide.com/news/content.nsf/news/852576140048867C85257726006FEE63