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Tracleer Treatment For Primary Pulmonary Hypertension, Tracleer PPH Treatment

Tracleer (known as bosentan) is a vasodilator drug approved by the FDA for the treatment of primary pulmonary hypertension (PPH). Tracleer is taken orally. It is produced by Patheon Inc. and is marketed by Actelion Pharmaceuticals. Primary pulmonary hypertension occurs when the blood pressure in the pulmonary artery becomes elevated. The scarring and cell growth resulting from PPH causes blood vessels in the lungs to narrow, restricting blood flow to lung tissue. The restriction of lung blood flow causes a backpressure in the heart. The backpressure allows less oxygen to get into the blood and causes the right ventricle of the heart to become overworked.

Tracleer Benefits

Tracleer is a vasodilator that works by blocking the effects of endothelin. Endothelin is a very potent vasoconstrictor that causes blood vessels to shrink in diameter. Endothelin naturally occurs in the body and is used in every organ to help regulate blood flow. Research shows that patients with primary pulmonary hypertension have elevated levels of endothelin in the blood stream. Since Tracleer relaxes blood vessels in the lungs and slows the process of cell growth and scarring in the lung vessels. This action prevents further narrowing of the lung vessels and increases the amount of oxygen saturation of the blood. Tracleer has been shown to improve exercise tolerance, oxygen saturation and cardiac output for PPH patients. Tracleer can help offset the effects of primary pulmonary hypertension and can help those patients awaiting lung transplants, or it can be used as an alternative to lung transplantation.

Primary Pulmonary Hypertension Treatment - Tracleer Treatment

Tracleer is a tablet and is used as an oral medication.

Tracleer Side Effects

Tracleer side effects include those related to systemic vasodilatation, such as nasal stuffiness, flushing, headache, passing out and hypo tension (abnormally low blood pressure). In addition, Tracleer has two significant side effects. Tracleer can negatively affect liver function and cause liver damage. Although data suggests that once Tracleer treatment is stopped, normal liver function appears to return, it is not yet known whether Tracleer causes permanent liver damage. Therefore, PPH patients taking Tracleer require liver function blood tests every month.

Tracleer has also been shown to be teratogenic, or harmful to fetuses. It is essential that patients on Tracleer treatment are not pregnant and do not become pregnant. Monthly pregnancy tests must be obtained. Further, Tracleer can alter the pharmacological properties of oral, injected or implanted contraceptives in a way that reduces their effectiveness. These contraceptive methods must be supplemented by other methods, or barriers must be used. It is important to consult with a gynecologist or other physician knowledgeable about contraceptives.

Tracleer Cost

Tracleer is considered a prescription drug for the treatment for PPH and is subject to the standard co-pay pricing schedules of the insurance companies and Medicare.

Tracleer Versus Remodulin and Flolan

Flolan and Remodulin are forms of prostacyclin, a prostaglandin analogue and potent vasodilator. Both require continuous infusion of treatment using a mini-pump that is worn on the belt or in a small shoulder pack. Flolan is a natural agent, and thus must be mixed on a regular daily basis and refrigerated after mixing. Remodulin is a synthetic form of prostacyclin and comes in a vile with a relatively long shelf life, requiring no refrigeration. Flolan is infused through a catheter that is surgically inserted into a chest vein, while Remodulin is infused under the skin (subcutaneously) in the abdominal area.

The big advantage of Tracleer is that is can be taken orally. For PPH persons with higher levels of activity (such as swimming), there is no mini-pump to interfere with these activities. Tracleer has a different mechanism of action than Remodulin or Flolan. It blocks the activity of endothelin receptors in the body. Endothelin is a potent vasoconstrictor that is present throughout the body and required for normal vascular regulation. Blocking the endothelin receptors can lead to other significant side effects, not present with Flolan or Remodulin.

Last Revision: December 18, 2007

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