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Study 351 Randomized, double-blind, placebo-controlled study of Tracleer 125 mg BID in patients with WHO functional class III or IV pulmonary arterial hypertension (N=32). One patient in each treatment group had no valid week 12 assessment and was not included in the analysis.
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. Channick RN, Simonneau G, Sitbon O, et al. Effects of the dual endothelin-receptor antagonist bosentan in patients with pulmonary hypertension: a randomised placebo-controlled study. Lancet. 2001;358:1119-1123.
2. Tracleer (bosentan) full prescribing information. Actelion Pharmaceuticals US, Inc. August 2009.
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Hemodynamics
