Why Tracleer?

Several studies have shown Tracleer to be effective in treating people with PAH WHO Functional Class II, III, and IV.^1,2,3

• Two studies focused on those with moderate to severe PAH (Functional Class III or IV). Learn more.
• One study focused on those with mild PAH (Functional Class II). Learn more.

The results of these studies are outlined below.

Tracleer is effective in treating patients with moderate to severe PAH (WHO Functional Class III-IV)

Tracleer has been extensively studied in patients with moderate to severe PAH. These studies found:

Tracleer may help you walk farther
Tracleer may slow the worsening of your disease
Tracleer may help improve your Functional Class
Tracleer may help your heart pump more efficiently

Tracleer may help you walk farther

In clinical studies, where exercise ability was assessed, many people taking Tracleer found they were able to walk farther than those not taking Tracleer.^1,2 You may notice an improvement in your ability to walk farther without getting short of breath.

In a clinical study of 213 patients with WHO functional class III-IV, researchers compared two groups of patients for 16 weeks: one group received Tracleer 125 mg or 250 mg* twice per day while the other received placebo (sugar pill). Patients who received Tracleer walked 36 meters farther in 6 minutes on average, while patients who received the placebo walked 8 meters less than their original distance.1 *Walking distance was somewhat greater with 250 mg twice daily, but the potential for increased liver injury causes this dose not to be approved.

Tracleer may slow the worsening of your PAH

In clinical studies, patients who took Tracleer had less worsening of PAH than patients taking placebo (sugar pill).^1,2

Clinical worsening is defined in these two studies as any one of the following: a need to go to the hospital for PAH, stopping treatment because of worsening of PAH, a need for intravenous (IV) treatment (epoprostenol), or death.1,2

Tracleer may help improve your Functional Class

In clinical studies, more patients who took Tracleer improved one WHO Functional Class compared to patients taking placebo.^1,2 Functional Class measures your ability to perform ordinary physical activities, such as walking, without feeling shortness of breath.^1,4

At the start of one of the studies, all patients were suffering from shortness of breath and fatigue with either minimal or no activity—placing them in either WHO Functional Class III or IV. By week 161: None of the patients who took Tracleer got worse. 42% of those taking Tracleer (n=144) improved by at least one WHO Functional Class vs. 30% of the patients taking placebo (n=69).

Learn more about Functional Class

Tracleer may lower the blood pressure in your lungs to help your heart pump
more efficiently

In one clinical study, Tracleer lowered high blood pressure and resistance in the pulmonary artery (major blood vessel) leading to the lungs to allow the heart to pump more efficiently^2†:

Research in patients with mild PAH (WHO Functional Class II)†† Tracleer has also been studied in patients with mild PAH. This study looked at: Resistance to blood flow in the pulmonary artery-Tracleer lowered resistance in the pulmonary artery and the lungs.3 6-minute walk distance-Patients with mild PAH did not show meaningful improvement in this test.3 In PAH, the relationship between how well the heart works and improvements in 6-minute walk distance is unknown. Researchers also found that Tracleer: Slowed the worsening of the disease-Clinical worsening in this study is defined as any one of the following: death from any cause, a need to go to the hospital for PAH, or increasing symptoms of PAH.3 Helped patients improve Functional Class-At the start of this study, all patients were in Functional Class II. This means they had some limitation in physical activity (no discomfort at rest, but normal activity would increase their symptoms).3

IMPORTANT SAFETY INFORMATION
Because of the risks associated with Tracleer, this medication may be prescribed by your doctor only through the Tracleer Access Program.

Liver damage: Tracleer can cause serious liver damage, including in rare cases liver failure and, in situations with regular liver testing, unexplained liver cirrhosis. So you must have a blood test to check your liver function before you start Tracleer and each month after that. Call your doctor right away if you have any of these symptoms of liver problems: nausea, vomiting, fever, unusual tiredness, abdominal (stomach area) pain, or yellowing of the skin or the whites of your eyes (jaundice).

Serious birth defects: Tracleer is very likely to cause serious birth defects. It is important not to be or to become pregnant while taking Tracleer or one month after stopping treatment and to have a pregnancy test before you start the drug and each month thereafter. It is very important for you to use reliable forms of birth control while taking Tracleer. Hormonal contraceptives should not be used alone because they may not be effective in patients taking Tracleer.

Do not take Tracleer with glyburide because it may increase your chance of liver injury. Do not take Tracleer with cyclosporine-A because it may increase your chance of side effects.

Please see Additional Safety Information.
Please see full Prescribing Information, including BOXED WARNING and Medication Guide.

View the Important Safety Information about Tracleer

REFERENCES:

1. Rubin LJ, Badesch DB, Barst RJ, et al. Bosentan therapy for pulmonary arterial hypertension. N Engl J Med. 2002;346:896–903.
2. Channick RN, Simonneau G, Sitbon O, et al. Effects of the dual endothelin receptor antagonist bosentan in patients with pulmonary hypertension: a randomized placebo-controlled study. Lancet. 2001;358:1119–1123.
3. Galiè N, Rubin LJ, Hoeper MM, et al. Treatment of patients with mildly symptomatic pulmonary arterial hypertension with bosentan (EARLY study): a double-blind, randomised controlled trial. Lancet. 2008; 371: 2093-2100.
4. Barst, RJ, McGoon M, Torbicki A, et al. Diagnosis and differential assessment of pulmonary arterial hypertension. J Am Coll Cardiol. 2004;43(Suppl S):40S–47S.
5. Farber HW, Loscalzo J. Pulmonary arterial hypertension. N Engl J Med. 2004;351:1655–1665.
6. Badesch DB, Abman SH, et al. Medical therapy for pulmonary arterial hypertension. Updated ACCP evidence-based clinical practice guidelines. Chest. 2007;131:1917–1928.