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Tracleer, (Bosentan), Lieff Cabraser Heimann & Bernstein, LLP:"For a more precise measurement of pulmonary pressures, patients are often counseled by physicians to undergo cardiac catheterization. Unlike echocardiography, however, cardiac catheterization is an invasive procedure and the test itself can be potentially risky. Cardiac catheterization can, however, be a much more definitive means of diagnosing pulmonary hypertension. Pulmonary hypertension is suspected if there is a pulmonary artery mean pressure which is > 25 at rest or > 30 with exercise. The only way to measure this pulmonary artery mean pressure is through cardiac catheterization. In addition, catheterization can reliably measure left heart pressures and can eliminate left heart failure as a cause of pulmonary hypertension. During a right-heart catheterization a thin, flexible tube called a Swan-Ganz catheter is inserted into a vein in the neck, upper chest area or groin. This catheter has a tiny balloon near its tip. The catheter is threaded to the right side of the heart and into the pulmonary artery, then the catheter introducer is sutured in place. The catheter directly measures pressures, giving the doctor systolic, diastolic and mean pulmonary artery pressures as well as right atrial pressure and cardiac output. When the balloon is in the pulmonary artery, it is inflated and the sensor tip beyond the balloon indirectly measures left-sided heart pressures. All of this information can be put together to calculate pulmonary vascular resistance. In addition, other numbers can be used to determine whether there is a congenital heart defect. An optional exercise component to right-heart catheterization is available in advanced catheterization clinics. Some diet drug victims have suggested that combining a cardiac catheterization with an exercise component may be another way to unmask pulmonary hypertension, particularly for those experiencing severe breathing problems subsequent to diet drug exposure but whose resting pulmonary artery pressures are otherwise believed to be normal. Some hypothesize that an increasing number of diet pill patients may surface who have normal resting pulmonary artery pressures but who have elevated pressures with exercise. During an exercise right heart catheterization, various pressures are measured at rest and then again while the patient exercises. In diet drug patients, upper body exercise may elicit increased pulmonary artery pressures. The exercise component can be done by having the patient lift liter IV bags with their arms. During exercise, pulmonary function tests are performed. The patient wears a nose clip and breathes into a machine that analyzes inspired and expired gases. The machine can tell when the anaerobic threshold is reached. The anaerobic threshold is reached much sooner in those with pulmonary hypertension because of the inability of the pulmonary arteries to function normally."
http://www.fen-phen-legal-resources.com/pph.htm

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Tracleer, (Bosentan), Online Lawyer Source:"Bosentan & Remodulin Associated to the use of diet drugs, including Fen Phen, Redux, and Pondimin, pulmonary hypertension begins when the small vessels supplying blood to the lungs constrict, making it more difficult for blood to pass to the lungs. The heart must pump harder as a result, leading to scarring of the vessels and completely blocking them in some instances. Bosentan and Remodulin are two drug treatments intended to relieve symptoms of pulmonary hypertension since there is no cure identified as of yet. Bosentan tablets work by blocking the hormone endothelin that has been found to exist in a higher level with pulmonary hypertension and is harmful to the lung and pulmonary arteries. Bosentan lowers the endothelin level to reverse the effects of hypertension created because the damaged lung and pulmonary arteries have created a blood flow resistance."
http://www.onlinelawyersource.com/bosentan/bosentan_use.html

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Tracleer, (Bosentan), VHA/LaurusHealth.com:"Description of Tracleer, (bosentan) tablets: Tracleer, (bosentan) tablets has been approved to improve the exercise ability of patients with a rare but fatal lung disorder called pulmonary arterial hypertension. Tracleer blocks the action of endothelin, a substance made by the body. Endothelin narrows blood vessels and elevates blood pressure. Although endothelin is present in healthy people, high concentrations of the hormone have been found in the plasma and lungs of patients with PAH (pulmonary arterial hypertension) suggesting it is capable of causing the disease."
http://www.laurushealth.com/Library/FDADrugApprovals/tracleer.htm

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Tracleer, (Bosentan), CenterWatch, Inc.:"Tracleer tablets have been approved by the FDA for the treatment of pulmonary arterial hypertension (PAH). This drug is indicated for use in improving exercise ability and decreasing the rate of clinical worsening in patients with WHO Class III or IV symptoms. Tracleer 125 mg (taken twice a day) is the first approved oral treatment for patients with PAH. Tracleer belongs to a class of drugs known as endothelin receptor antagonists (ERAs). Patients with PAH have elevated levels of endothelin, a potent blood vessel constrictor, in their plasma and lung tissue. Tracleer blocks the binding of endothelin to its receptors, thereby negating endothelin's deleterious effects."
http://www.centerwatch.com/patient/drugs/dru738.html

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Tracleer, (Bosentan), Doctor's Guide:" NEW ORLEANS, LOUISIANA -- November 14, 2000 -- The investigational oral drug, bosentan, appears to increase exercise function of patients with moderate to severe pulmonary hypertension, researchers reported here at the 73rd annual scientific sessions of the American Heart Association. About 100,000 people in North America and Europe have pulmonary hypertension. Lewis Rubin, MD, professor of medicine at the University of California at San Diego, said bosentan is designed to control endothelin, a destructive molecule that causes blood vessels constriction and cell proliferation, the beginnings of the cascade of molecular events that leads to pulmonary hypertension. "Bosentan is like ‘ScotchGuard’ for the blood vessels," Dr. Rubin said. The drug blocks the ability of circulating endothelin to attach to receptors on cells where it can start the chain of events that causes inappropriate constriction of blood vessels and inappropriate cell growth."
http://www.pslgroup.com/dg/1eaa82.htm

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Tracleer, (Bosentan), The Flolan information center:" FDA today announced the approval of Tracleer (bosentan) tablets to improve the exercise ability of patients with a rare but fatal lung disorder called pulmonary arterial hypertension. Pulmonary arterial hypertension (PAH) is defined as abnormally high blood pressure in the arteries between the heart and lungs. PAH significantly reduces the ability of patients to exert themselves physically without becoming short of breath. PAH significantly shortens the life span of patients because it leads to heart failure. Tracleer blocks the action of endothelin, a substance made by the body. Endothelin narrows blood vessels and elevates blood pressure. Although endothelin is present in healthy people, high concentrations of the hormone have been found in the plasma and lungs of patients with PAH suggesting it is capable of causing the disease. The use of Tracleer requires attention to two significant risks: liver toxicity and the drug's potential to damage a fetus. In order to ensure careful attention to monitoring for these risks, Tracleer will be available only through a direct distribution program from the drug's manufacturer, Actelion Pharmaceuticals US, Inc., of South San Francisco, Calif. It will not be available in commercial pharmacies."
http://www.flolan-center.com/pages/tracleer.html

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Tracleer, (Bosentan), Tracleer Information Center:"Tracleer (Bosentan) Made by Actelion * was one of the first available oral forms of of Prostacyclin. It has been made available to patients at the University of Pittsburgh Medical Center as part of a clinical trial. Bosentan works by blocking the action of a hormone called endothelin. Endothelin exists in higher levels in people with PH is a hormone that is harmful to the lung and pulmonary arteries. The damaged lung and pulmonary arteries create the blood flow resistance that results in hypertension. Bosentan was designed to offset endothelin, lowers the endothelin levels, reversing its effects, resulting in lower artery pressure."
http://www.tracleer-pph.com/pages/tracleer_info.html

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Tracleer, (Bosentan), Cardiology Online, Inc.:" ATLANTA, Georgia (ACC) -- Although the initial results of the ENABLE (Endothelin Antagonist Bosentan for Lowering Cardiac Events in Heart Failure) trial were discouraging, they provide possible support for the potential use of endothelin antagonists as a treatment for moderate-to-severe heart failure, reported Milton Packer, MD, of Columbia Presbyterian Medical Center in New York City."
http://www.cardiologyonline.com/Enable.htm

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