Tracleer (Bosentan) is a FDA approved treatment for 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 new PAH treatments developed. The drug is pronounced Tra Kleer.
Endothelin, becomes more abundant in patients with pulmonary hypertension. This increased concentration of endothelin is believed to be a possible cause of PAH because it narrows blood vessels and elevates blood pressure. By reducing the endothelin level, Tracleer 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 Tracleer, the Pulmonary Hypertension treatment version of this drug was made available only through a direct distribution program from Tracleer'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 PAH, were reclassified
as having moderate PAH after Tracleer use for 12 weeks.
Effects of Tracleer:
According to material published by the maker of Tracleer, the
drug "has been demonstrated to work as early as four weeks
in some patients; other patients may need as long as several
months to realize the benefits of Tracleer." Tracleer may
also help improve patients ability to exercise, according the
the drug maker, in clinical studies the ability to exercise was
measured and many PAH patients on Tracleer were able to walk
farther than those not taking Tracleer. Thus advises tracleer
patients may notice an improvement their ability to perform daily
tasks without getting as tired or out of breath before the drug
therapy. The company notes that patients
may not always experience the beneficial effects. Additionally
the drug can have several harmful side effects including birth
defects and liver damage. Patients taking tracleer should be
under a doctor's care with liver function testing
Tracleer is a prescription medicine available only through designated specialty distributor pharmacies. Bosentan is not available through traditional retail pharmacies. To obtain Tracleer you will need a completed patient enrollment form filled out by your doctors to the Tracleer Access Program (TAP).
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