Don't watch and wait in pulmonary arterial hypertension

Untreated patients will deteriorate

EARLY (FC II) Clinical worsening in placebo-treated patients
highlights the progressive nature of the disease^1,2

Clinical worsening defined as1:   Death   Hospitalization due to PAH   Symptomatic progression of PAH

EARLY Endothelin Antagonist tRial in miLdlY symptomatic PAH patients. Randomized, double-blind, placebo-controlled trial of Tracleer 125 mg BID in patients with functional class II PAH (N=185). 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. Both the Tracleer group and the placebo group included some patients on sildenafil at baseline (Tracleer, n=14; placebo, n=15).¹

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.

Start Tracleer First

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.