Aminaftone in the Treatment of Raynaud’s Phenomenon in Systemic Sclerosis: New Perspectives

Abstract

Objective: The aim of this study was to assess the efficacy (in terms of improved VAS Pain, Raynaud's Phenomenon attacks frequency and Raynaud’s Condition Score) of the Aminaftone in patients with Raynaud’s Phenomenon (RP) secondary to Systemic Sclerosis (SSc). Methods: Open label controlled study. We evaluated the efficacy of Aminaftone in the treatment of secondary RP in 108 patients with SSc consecutively recruited and divided in two groups. Group A: 51 Patients in treatment with Calcium Channel Blockers, prostanoids (iloprost 2ng [min/kg every 4 weeks), Endothelin Receptor Antagonist and Phosphodiesterase-5 inhibitors (Standard of Care). Group B: 57 Patients in treatment with Calcium Channel Blockers, Prostanoids, Endothelin Receptor Antagonist and Phosphodiesterase-5 inhibitors and Aminaftone (Standard of care + Aminaftone). Results: The number of RP attacks in group treated with Aminaftone (Group B) was lower than the group treated with standard therapy (Group A) from baseline to Week 48, obtaining statistically significance (Δ A -1.50 Δ B -2.10 p=0.02 95%CI). The RCS was statistically significantly different (Δ A -1.60 Δ B -2.50 p=0,04 95% CI), as was the pain VAS(Δ A -20.80 Δ B -30.60 p=0.04 95%CI) at week 48. Conclusion: The use of Aminaftone was well tolerated and improved RP as measured by RCS and pain when added to standard of care. A well-designed randomized controlled trial is needed to determine if these preliminary findings are supported