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Pivotal Pulmonary Arterial Hypertension Study Published in The Lancet Concludes That Bosentan (Tracleer(R)) Demonstrates Benefits in Patients With Mildly Symptomatic WHO Functional Class II Disease
Date:6/20/2008

to the fingers and toes causing open sores. DUs are painful, with a debilitating impact on patients' daily life, often making it impossible to work and undertake even simple day-to-day activities, particularly those associated with fingertip function. Reducing the occurrence of new DUs is an important and achievable treatment goal in SSc.

In the EU Tracleer(R) is indicated to reduce the number of new digital ulcers in patients with systemic sclerosis and ongoing digital ulcer disease. Tracleer(R) has been shown to improve hand function (i.e. dressing and hygiene) in patients with scleroderma-induced digital ulcers.

Requires attention to two significant safety concerns: Potential for serious liver injury (including 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 by two forms of birth control; monthly pregnancy tests should be obtained. Because of these risks, Tracleer(R) is only supplied through a controlled distribution.

References

1. Galie 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. The Lancet 2008;

371: 2093-2100.

2. 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. The Lancet 2001;

358: 1119-23 (Study 351).

3. Rubin LJ, Badesch DB, Barst RJ et al. Bosentan therapy for pulmonary

arterial hypertension. NEJM 2002; 346: 896-903 (BREATHE-1).

4. Sitbon O, Humbert M, Jais X et al. Long-term response to calcium

channel blockers in idiopathic pulmonary
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SOURCE Actelion Ltd
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