Effect of the dual endothelin receptor antagonist bosentan on Raynaud's phenomenon secondary to systemic sclerosis: a double-blind prospective, randomized, placebo-controlled pilot study

Abstract

European Union Drug Regulating Authorities Clinical Trials, https://eudract.emea.europa.eu, EudraCT-Nr 2004-002686-21.

Contemporary management of Raynaud's phenomenon and digital ischaemic complications

“…At present, there is no evidence base to support the use of ET-1 receptor antagonists for the treatment of Raynaud's phenomenon in the absence of digital ulcers. A single-centre, double-blind, parallel-group trial of 17 patients with SSc (but without digital ulcers) reported no benefit in terms of Raynaud's symptoms from 16 weeks' treatment with bosentan [34].…”

Drug Treatment of Raynaud’s Phenomenon

“…Bosentan did not improve the frequency, duration, pain or severity of RP attacks. While Bosentan may prevent digital ischemic ulcers in patients with SSc is not effective in RP treatment [ 85 ]. …”

Pulmonary Arterial Hypertension in Connective Tissue Diseases

“…Эффективность бозентана в отношении дигитальных ишемических нарушений была показана в двух плацебо-контролируемых рандомизированных испытаниях (RAPIDS-1 и RAPIDS-2), включающих 210 пациентов с ССД [42,43]. Бозентан в начальной дозе 62,2 мг дважды в день в течение 4 нед, а затем 125 мг дважды в день в тече-ние 12 нед статистически значимо снижал частоту возник-новения новых дигитальных язв (на 48%) в сравнении с плацебо.…”