Bosentan, better known as Tracleer is a FDA approved treatment made by Actelion for primary pulmonary hypertension. The drug works by lowering the levels of a naturally occurring vasoconstricter called endothelin in the blood. The drug is particularly noteworthy because unlike prostacylin, it can be taken in tablet form. It is one of the least invasive PAH treatments developed. The drug as of the beginning of 2007 has sales of over 550 Million dollars, attesting to its widespread use.

Endothelin, becomes more abundant in patients with pulmonary hypertension. This increased concentration of endothelin is believed to be a possible cause of PPH because it narrows blood vessels and elevates blood pressure. By reducing the endothelin level, Bosentan reverses this effect and assists blood flow.

Based on two randomized, placebo-controlled clinical trials, the FDA determined Bosentan an effective treatment for pulmonary hypertension. However, because of serious side effects associated with Bosentan, the Primary Pulmonary Hypertension treatment version of this drug was made available only through a direct distribution program from Bosentan's manufacturer Actelion Pharmaceuticals.

Reports are mixed on the exact effectiveness of Bosentan. One four month trial discovered that Bosentan demonstrated only "small but measurable beneficial effects" and concluded that though the duration of the test was not sufficient to determine a difference in mortality, its results suggested that the drug had a therapeutic role in some patients with Primary Pulmonary Hypertension.

However, a subsequent test found improvement in 43% of the patients using it and those users who had severe cases of PH, were reclassified as having moderate PH after Bosentan use for 12 weeks.

Bosentan is a prescription medicine available only through designated specialty distributor pharmacies. Bosentan is not available through traditional retail pharmacies. To obtain Bosentan you will need a completed patient enrollment form filled out by your doctors to the Tracleer Access Program.


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