Bosentan for Digital Ulcers in Patients with Systemic Sclerosis: A Prospective 3-year Followup Study

Bosentan is Effective Against Digital Ulcerations and Hyperkeratosis in Systemic Sclerosis

“…Bosentan is licensed for prevention rather than therapy of DUs, based on two randomized, double-blind, placebocontrolled trials; RAPIDS-1 and RAPIDS-2 (5,6). However, in some patients (7)(8)(9), in a retrospective study ( 10) and three prospective, open-label studies (2,11,12), it also had a curative effect. These clinical observations confirm the hypothesized role of endothelin in the pathogenesis of DUs.…”

Advances in the treatment of Raynaud’s phenomenon

“…Bosentan 62.5 mg twice daily for the first month, then 125 mg twice daily for an additional 35 weeks was administered. Healing of ulcers was reported in 65% of patients after a median of 25 weeks (range 8 to 26 weeks) 46. Reduction in ulcers, improved ulcer healing, and improvement in RP frequency and severity have also been reported in several case series and case reports including patients with systemic sclerosis 47–53.…”

Endothelin Receptor Antagonists for the Treatment of Raynaud's Phenomenon and Digital Ulcers in Systemic Sclerosis

“…Healing of DU was observed after a median of 20 weeks (range 16–24 weeks) for 6 of the 8 patients who had DU at baseline. The longest prospective open label study of bosentan was a 3 year trial of 26 patients with DU refractory to CCB, ACE-inhibitors or sildenafil, published in 2009 [46]. Complete healing of DU occurred in 17 of the 26 participants (65%) after a median period of 25 weeks (range 8–26 weeks), and improvement was noted in the DU of 4 additional patients.…”