CI, cardiac index; RAP, right atrial pressure; PVR, pulmonary vascular resistence; PAP, pulmonary arterial pressure.
*BREATHE-1 Multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of Tracleer (125 mg BID, 250 mg BID) in patients with WHO functional class III or IV pulmonary arterial hypertension (N=213). All patients (n=144 in the Tracleer group and n=69 in the control group) participated in the first 16 weeks. A subset of this population (n=35 in the Tracleer group and n=13 in the control group) continued for up to 28 weeks. Clinical worsening was defined as the combined endpoint of death, hospitalization for treatment related to PAH, discontinuation of therapy due to worsening PAH, or initiation of epoprostenol therapy.
†Study 351 Randomized, double-blind, placebo-controlled study of Tracleer 125 mg BID vs placebo in patients with WHO functional class III or IV pulmonary arterial hypertension (N=32).
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. Data on file, Actelion Pharmaceuticals.
2. Rubin LJ, Badesch DB, Barst RJ, et al. Bosentan therapy for pulmonary arterial hypertension. N Engl J Med. 2002;346:896-903.
3. Tracleer (bosentan) full prescribing information. Actelion Pharmaceuticals US, Inc. August 2009.
4. 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.
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About Tracleer
