Diagnose PAH early      Start Tracleer first Don't watch and wait: untreated FC II patients will deteriorate1    EARLY: 14% of placebo-treated patients and 3% of Tracleer-treated patients experienced ≥1 clinical worsening event by month 6.1 Tracleer: over 8 years of clinical experience, prescribed to over 75,000 patients2

Tracleer is indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) in patients with WHO Class II-IV symptoms, to improve exercise ability and decrease the rate of clinical worsening. Patients with WHO Class II symptoms showed reduction in the rate of clinical deterioration and a trend for improvement in walk distance. Physicians should consider whether these potential benefits are sufficient to offset liver injury in WHO Class II patients, which may preclude future use as their disease progresses.

Important safety information

Because of the associated risks, Tracleer may be prescribed only through the Tracleer Access Program.

Potential for serious liver injury (including, after prolonged treatment, rare cases of liver failure and unexplained hepatic cirrhosis in a setting of close monitoring)—Liver monitoring of all patients is essential prior to initiation of treatment and monthly thereafter.

High potential for major birth defects—Pregnancy must be excluded and prevented through the use of reliable forms of birth control; monthly pregnancy tests should be obtained.

Contraindicated for use with cyclosporine A and glyburide.

Please see full prescribing information including BOXED WARNING.

Read more about PAH

EARLY Endothelin Antagonist tRial in miLdlY symptomatic PAH patients. The first and only randomized, double-blind, placebo-controlled trial conducted solely in mildly symptomatic (functional class II) patients with PAH (N=185). Patients were randomized to Tracleer (62.5 mg BID, 125 mg BID) or placebo. Trial duration was 6 months. Concomitant use of anticoagulants and calcium channel blockers was allowed.¹

Clinical worsening was defined as death, hospitalization due to PAH, or symptomatic progression of PAH. Symptomatic progression of PAH was defined as the presence of 1 of the following: appearance or worsening of right heart failure (as assessed by the investigator), decrease ≥10% from baseline in two 6-minute walk tests performed ≥2 weeks apart, or ≥5% decrease from baseline in two 6-minute walk tests performed ≥2 weeks apart associated with ≥2-point increase in Borg dyspnea index. Baseline functional class status: 100% FC II. Both the Tracleer group and the placebo group included some patients on sildenafil at baseline (Tracleer, n=14; placebo, n=15).¹

1. 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.
2. Data on file, Actelion Pharmaceuticals.