Bosentan: a review of its use in the management of digital ulcers associated with systemic sclerosis.

Bosentan (Tracleer) is an orally administered dual endothelin-1 (ET-1) receptor antagonist approved in the EU for reducing the number of new digital ulcers in patients with systemic sclerosis and ongoing digital ulcer disease. Oral bosentan therapy was beneficial and generally well tolerated in patients with digital ulcers associated with systemic sclerosis. In well designed, placebo-controlled trials, bosentan treatment significantly reduced the number of new ulcers, but had no effect on ulcer healing, in patients with digital ulcers. Adverse events associated with bosentan were consistent with those seen during treatment for other indications, with major concerns being the potential for teratogenicity and hepatotoxicity, for which regular liver function monitoring is recommended. Overall, considering the large unmet need for therapeutic options in patients with digital ulcers, bosentan extends the treatment options available to patients with systemic sclerosis-associated digital ulcers.