Table 2.

Summary of bosentan clinical trials on Raynaud’s phenomenon (RP)

Patients	Study design	Treatment	Outcomes	References
122 patients secondary RP	Randomized double-blind placebo-controlled	Bosentan 62.5 mg twice daily × 4 weeks, then 125 mg twice daily × 12 weeks	Fewer new digital ulcers per patient with bosentan (primary study outcome; mean of 1.4 new ulcers per patient on bosentan vs 2.7 new ulcers per patient on placebo [P = 0.0083]) No difference in percentage of patients with new digital ulcers, time to first ulcer, ulcer healing, or functional improvement	42
188 patients secondary RP	Randomized double-blind placebo-controlled	Bosentan 62.5 mg twice daily × 4 weeks, then 125 mg twice daily × 20–32 weeks	Fewer new digital ulcers per patient with bosentan (primary study outcome; mean of 1.9 new ulcers per patient on bosentan vs 2.7 new ulcers per patient on placebo [P = 0.035]) No difference in time to healing of cardinal ulcer, time to healing of all digital ulcers, and percent with complete healing	44