New hope for patients with fatal lung disorder

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There’s new hope for Canadian patients suffering from pulmonary arterial hypertension (PAH), a highly fatal condition with a 50% risk of death within three years if left untreated.

Important long-term data, just presented at the 2003 annual American Thoracic Society meeting, showed that patients treated with Tracleerª (bosentan) tablets had a survival rate of 86% versus a predicted survival rate of 48% at three years.

“Earlier pivotal studies found that treatment with Tracleer provided symptomatic benefits, as well as decreased rates of clinical worsening over a 16 week period of study,” said Dr. John Granton, a respirologist at Toronto General Hospital in Toronto, ON. “However, the results reported at the American Thoracic Society meeting support the notion that treatment with Tracleer may be associated with improved survival over longer periods of time.”

“These study results are exciting news. By improving exercise capacity and increasing the rate of survival, Tracleer should be considered for the early treatment of patients with PAH,” said Leon Paroian, President of Pulmonary Hypertension Society of Canada.

The StudyThe data is based on the records of 169 patients with primary pulmonary hypertension (PPH) who were treated with Tracleer and observed for up to 39 months.

Analysis of the data at 12, 24 and 36 months found a survival rate of 96%, 89% and 86%, respectively, for patients treated with Tracleer, compared to a predicted survival rate of 69%, 57% and 48% respectively. This underscores the importance of initiating treatment early in the course of the disease.

“PAH is a devastating disease with high morbidity and mortality,” said Dr. Sanjay Mehta, Director of the South Western Ontario Pulmonary Hypertension Centre in London, ON. “These new and exciting data show that Tracleer not only improves exercise capacity and reduces symptoms, but may also have a significant impact in patients by slowing the natural progression of PAH.”

“I was 42 years old when I was diagnosed with pulmonary arterial hypertension,” explains Jill Abbey from Peterborough, ON. “I would get exhausted by just climbing one flight of stairs or walking from my front door to the car. My physician suggested I try Tracleer and immediately I noticed the difference. I can now walk longer distances and I just swam my first lap in the pool. Also, I have greater peace of mind knowing that this treatment is prolonging my life.”

About TracleerTracleer, the first oral agent indicated for the treatment of PAH, has demonstrated its efficacy in two pivotal, placebo-controlled studies. It has shown statistically significant improvements in exercise capacity with patients achieving a greater increase in walking distance compared to placebo.

It works by blocking the action of endothelin, a substance produced by the body that is also present in healthy people. However, high concentrations of endothelin found in PAH cause artery narrowing, artery thickening and tissue overgrowth, increases of the production of collagen and also inflammation, a process associated with an immune response which is characterized by pain, swelling and oedema. These complications result in high pulmonary artery blood pressure.

Tracleer is manufactured by Actelion Ltd., a biopharmaceutical company headquartered in Allschwil, Switzerland. Actelion is the global leader in creative science related to the endothelium – the single layer of cells separating every blood vessel from the blood stream. Its Canadian operations are headquartered in Laval, Quebec.