Navigation Links
Viagra Trial for Sickle Cell Lung Problems Halted
Date:7/28/2009

Safety concern from side effects prompts action by U.S. government

TUESDAY, July 28 (HealthDay News) -- The first clinical trial of a treatment for pulmonary hypertension in adults with sickle cell anemia has been stopped because of severe side effects in some participants.

The trial involved sildenafil -- marketed as Viagra when it is used to treat erectile dysfunction and Revatio when used for pulmonary arterial hypertension, or high blood pressure in the lungs.

"This was a very big disappointment," said Dr. Mark Gladwin, lead investigator of the study, which was sponsored by the U.S. National Heart, Lung, and Blood Institute. "We were very excited about this drug. It has a very high safety profile and has worked in every form of pulmonary hypertension. The preliminary data showed a lowering in pulmonary hypertension in sickle cell patients."

Pulmonary hypertension affects as many as 30 percent of people with sickle cell disease. "It's the highest risk of death, so it's a very important complication," said Gladwin, who is director of the Vascular Medicine Institute at the University of Pittsburgh.

People with sickle cell disease have an average of two so-called "crises" a year, involving severe pain and often requiring hospitalization. The crises occur when red blood cells, which are misshaped in those with the disease, get jammed up in the blood vessels, blocking blood flow.

An estimated 70,000 to 100,000 people in the United States have this genetic blood disorder, most of them black.

According to the institute, there are no current guidelines for treating pulmonary hypertension in people with sickle-cell disease, although drugs known as endothelin receptor blockers are sometimes used. The condition can lead to heart failure and death.

A small pilot trial using Revatio and involving just 12 people with sickle cell anemia had found a decrease in pulmonary hypertension. But the participants were also aggressively treated with transfusions and the drug hydroxyurea to control crises.

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.

"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.



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


'/>"/>
Copyright©2009 ScoutNews,LLC.
All rights reserved  

Related medicine news :

1. After 10 Years A Stronger and More Enhanced Form of Viagra Now Available
2. Video: Bathmate Hydropump Poised to Replace Cialis, Levitra, and Viagra
3. Rapid Generic Erosion of Branded Agents, Including Market-Leading Viagra, Will Cause Sales of Erectile Dysfunction Drugs to Remain Flat Over the Next Decade
4. Viagra May Shield Heart From Blood Pressure Damage
5. Viagra Bulk Effectively Cures Children with PAH (Pulmonary Arterial Hypertension)
6. For Patients Who Fail on Viagra, Levitra or Cialis
7. Viagra May Protect Hearts of Some Muscular Dystrophy Patients
8. TriMix-gel vs Viagra, Levitra, Cialis Data to Be Presented at AUA
9. AUDIO from Medialink and Pfizer: Viagras 10th Anniversary
10. An Important Message to Anyone Taking Viagra ... From The Women Who Love You ... and Zoller Labs
11. MULTAQ(R) (dronedarone) for Atrial Fibrillation or Atrial Flutter Now Available in the United States
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
Viagra Trial  for Sickle Cell Lung Problems Halted
(Date:6/25/2016)... , ... June 25, 2016 , ... As a lifelong ... Cum Laude and his M.D from the David Geffen School of Medicine at UCLA. ... to Los Angeles to complete his fellowship in hematology/oncology at the UCLA-Olive View-Cedars Sinai ...
(Date:6/25/2016)... ... June 25, 2016 , ... Conventional wisdom preaches the benefits ... terms of the latter, setting the bar too high can result in disappointment, perhaps ... slow progress toward their goal. , Research from PsychTests.com reveals that ...
(Date:6/24/2016)... ... 24, 2016 , ... June 19, 2016 is World Sickle Cell Observance Day. ... the benefits of holistic treatments, Serenity Recovery Center of Marne, Michigan, has ... , Sickle Cell Disease (SCD) is a disorder of the red blood cells, which ...
(Date:6/24/2016)... , ... June 24, 2016 , ... Global law firm ... 2016 Legal Elite. The attorneys chosen by their peers for this recognition are considered ... Seven Greenberg Traurig Shareholders received special honors as members of this year’s Legal Elite ...
(Date:6/24/2016)... , ... June 24, 2016 , ... Topical BioMedics, Inc, makers of Topricin and MyPainAway ... call for a minimum wage raise to $12 an hour by 2020 and then adjusting ... restore the lost value of the minimum wage, assure the wage floor does not erode ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... 23, 2016 Capricor Therapeutics, ... a biotechnology company focused on the discovery, development ... patient enrollment in its ongoing randomized HOPE-Duchenne clinical ... 50% of its 24-patient target. Capricor expects the ... quarter of 2016, and to report top line ...
(Date:6/23/2016)... PARK RIDGE, Ill. and INDIANAPOLIS ... caliber of students receiving a Lilly Diabetes Tomorrow,s Leaders ... hands. The 2016 scholarship winners, announced today online at ... refused to let type 1 diabetes stand in the ... Lilly Diabetes has supported the Foundation,s scholarship program since ...
(Date:6/23/2016)... -- The vast majority of dialysis patients currently receive ... usually 3 times a week, with treatment times averaging ... equipment preparation and wait time.  This regimen can be ... who are elderly and frail.  Many elderly dialysis patients ... for some duration of time. Residents in ...
Breaking Medicine Technology: