*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. Clinical worsening events were defined as death from any cause (during the treatment period or as the outcome of a treatment-emergent adverse event that led to permanent discontinuation of study treatment), hospitalization due to PAH complications, or symptomatic progression of PAH.1,2

PVR: pulmonary vascular resistance.

Tracleer is indicated for the treatment of pulmonary arterial hypertension (PAH) 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 the risk of 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.

REFERENCES

1. Tracleer (bosentan) full prescribing information. Actelion Pharmaceuticals US, Inc. August 2009.

2. 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.

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