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Viagra Trial for Sickle Cell Lung Problems Halted
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Page: << Prev | 1 | 2 In the multicenter trial that was stopped, 134 people were treated with Revatio but without the interventions for crises. "We wanted to test the drug in the way it would probably used in doctors' offices," Gladwin said.
When it was stopped July 7, more than a year early, 33 people had completed the trial, having received 16 weeks of treatment with Revatio or placebo. More than a third (38 percent) of those given the drug had severe side effects, mostly sickle cell pain crises, compared with 8 percent of people taking the placebo.
Researchers are now looking at the efficacy of the drug: Did it actually have any effect, positive or negative, on pulmonary hypertension? If there were positive effects, the researchers said, there may be other ways it could be used.
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"It may be that we could use the drug in patients whose pain is controlled with either transfusions or hydroxyurea, although it's possible that the risk-benefit ratio would only play out in patients with higher pulmonary hypertension," Gladwin said. "The patients in this trial had mild-to-moderate pulmonary hypertension."
The investigators don't know why the trial produced the increased risk for pain crises, but they said there was no indication that the drug is not safe in other populations.
Pfizer, which makes Viagra and Revatio, provided the drug as well as the placebo for the trial.
More information
The U.S. National Heart, Lung and Blood Institute has more on sickle cell disease.
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Copyright © 2009 ScoutNews, LLC. All rights reserved.
Last updated 7/28/2009
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SOURCES: Mark T. Gladwin, M.D., division chief, Pulmonary, Allergy and Critical Care Medicine, University of Pittsburgh Medical Center, and director, Vascular Medicine Institute, University of Pittsburgh; U.S. National Heart, Lung and Blood Institute, news release, July 28, 2009
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