NHLBI stops study of pulmonary hypertension treatment in sickle cel...(rmerly a senior investigator with the Cr...),Health

The design of the walk-PHaSST study was based on extensive evidence that sildenafil improves pulmonary hypertension regardless of its cause and on results of a small, open-label, nonrandomized pilot study led by Gladwin while he was at the NIH. The pilot study evaluated 12 sickle cell patients with mild or moderate pulmonary hypertension who were being treated with sildenafil and with hydroxyurea, a drug known to help reduce the numbers of episodes of sickle cell pain crises and acute chest syndrome, as well as hospitalizations and blood transfusions needed. In 2005, Gladwin and his colleagues reported that after about 6 months, sildenafil was well tolerated, decreased pulmonary blood pressure, and increased exercise capacity.

"Walk-PHaSST emphasizes the importance of multi-site, blinded, randomized clinical trials to increase our understanding of both the benefits and the potential risks of specific treatments," noted Jonathan C. Goldsmith, M.D., NHLBI project officer of walk-PHaSST. "As with all clinical studies, patient safety is paramount."

Walk PHaSST was conducted at the following locations:

• Children's Hospital, Oakland, Calif.
• University of Colorado, Denver
• Howard University Hospital, Washington, D.C.
• University of Illinois at Chicago
• Johns Hopkins Medical Institutions, Baltimore
• NIH Clinical Center, Bethesda, Md.
• Albert Einstein College of Medicine, New York City
• Columbia University, New York City
• Children's Hospital, Pittsburgh
• Imperial College London and Hammersmith Hospital, London, England

Rho Inc. of Chapel Hill, N.C., serves as the data coordinating center. Pfizer provided the treatment drug and placebo for the study.

Sickle cell anemia affects millions of people worldwide
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