SILVER SPRING, Md., Nov. 1 /PRNewswire/ -- On Wednesday, October 27, 2004 at the American College of Chest Physicians, Pfizer released their first clinical trial results for use of Viagra (Sildenafil) in the treatment of pulmonary hypertension. The 12 week clinical trial, involving 278 patients, showed increases in the six minute walk test used as a standard in PH trials.
While FDA review is in the future, the Pulmonary Hypertension Association (PHA) is pleased whenever new treatments show possibilities for use with pulmonary hypertension (PH). Until 1996, when FDA approved Flolan, there were no disease-specific treatments for pulmonary hypertension. In 2001, two new treatments were approved Tracleer (Bosentan) and Remodulin (treprostinil sodium). In addition, Thelin (sitaxsentan), Ambrisentan, and Ventavis (inhaled iloprost) are all in various stages of clinical trials for use with PH.
In a recent draft of an unpublished Surveillance Report, the Centers for Disease Control points to a fact that PHA has long believed ... pulmonary hypertension should no longer be viewed as a rare illness but rather as an emerging chronic illness.
According to Rino Aldrighetti, PHA's president, "When there were no treatments, doctors had no reason to look for an illness that could only be diagnosed by exclusion and was untreatable despite their best efforts. Now that treatment is available our job at PHA is to fight to make physicians and the public aware of PH and its symptoms."
Pulmonary hypertension is an illness in which the blood pressure in the lungs rises above normal levels. This condition causes decreased oxygen levels in the blood and strain on the heart which pumps harder to push blood to the lungs. Though PH can affect people of all demographics, the profile of the average PH patient is a woman of child-bearing years.
Early symptoms of pulmonary hypertension are similar to those of other lung and heart conditions, and because of this fact PH is often misdiagnosed as other less severe illnesses such as asthma, chronic bronchitis, and congestive heart disease. PH symptoms include:
- Chest pain
- Low energy
- Dizziness and fainting
- Swollen ankles and legs
Though there is no known cure for PH, patients can benefit from medication if diagnosed in time. The PH medical community is hopeful that Viagra may prove to be another treatment for the illness, but cautions that the medication is still in trials and has not been FDA approved.
"Sildenafil is still investigational and the data has not yet undergone rigorous review by the FDA. PAH is still considered an 'off-label' indication for Sildenafil, and some insurance companies may not pay for Sildenafil when used for this indication," says pulmonary hypertension specialist, Vallerie McLaughlin, M.D. of the University of Michigan.
Fifty percent of PH patients survive to five years from diagnosis. This is an improvement from only five years ago, when 50% of patients survived two to three years. As new treatments become available and research is providing greater understanding of the illness, prognosis continues to move in the right direction.
The Pulmonary Hypertension Association is the nation's leading non-profit organization for PH research, public awareness, and services. The organization has over 6,000 members, including patients, family members and medical professionals. PHA also publishes Advances in Pulmonary Hypertension, the world's first medical journal dedicated to PH research. The organization reaches out to the PH community through almost 110 support groups and a patient-to- patient telephone helpline, among many other activities. For more information please visit: http://www.phassociation.org/ .
Pulmonary Hypertension Association