Background Aminaphtone (1,4-Dihydroxy-3-methyl-2-naphthyl-4-aminobenzoate) is a vasoactive drug that was recently demonstrated to improve the symptoms of Raynaud's phenomenon (RP) and to down-regulate endothelin-1 production by endothelial cells (1–3).
Objectives To evaluate skin blood perfusion and clinical symptom changes during aminaphtone treatment in patients with both primary and secondary RP, during a six-month follow-up.
Methods Forty-six patients with active RP were enrolled during routine clinical assessment in November 2015 (11 primary RP, mean age 49±19SD years, mean RP duration 6±3 years; 35 secondary RP to systemic sclerosis, mean age 61±17 years, mean RP duration 11±9 years), after informed consent. Aminaphtone was administered 75 mg twice daily (off label) in addition to current treatments (the patients were on a stable drug regimen for at least two months before, which remained unmodified during the follow-up). Blood perfusion was measured by Laser Speckle Contrast Analysis (LASCA) and values recorded as perfusion units (PU) (4), at the level of fingertips, periungual areas, dorsum and palm of hands, and face, at baseline (T0), after one (T1), four (T4), twelve (T12) and twenty-four (T24) weeks of treatment. Raynaud's condition score (RCS) and both frequency and duration of Raynaud's attacks were assessed at the same time. Forty-six patients with RP (9 primary RP and 37 secondary RP to systemic sclerosis) not treated with aminaphtone were also enrolled as a control group and evaluated at T0 and T24.
Results A progressive statistically significant increase of blood perfusion was observed from T0 to T12 in all skin areas analyzed (median PU at T0, T1, T4, T12, T24 respectively: fingertips 55, 88, 101, 107, 98 periungual areas 44, 88, 91, 92, 92; dorsum of hands 38, 61, 71, 75, 75; palm of hands 56, 85, 89, 94, 82; whole face 127, 138, 144, 159, 129; p<0.001 for all areas). From T12 to T24 was not observed any further increase of blood perfusion. A progressive statistically significant decrease of RCS (median at T0, T1, T4, T12, T24: 7, 6, 4, 4, 4; p<0.0001), frequency of Raynaud attacks/day (median: 2, 2, 1, 1, 1; p<0.0001) and Raynaud duration (median: 20, 20, 10, 4, 4 minutes; p<0.0001) was also recorded from T0 to T12. The results were similar in both primary and secondary RP patients (p=0.40). Aminaphtone administration had to be stopped in 2 patients due to headache, and one patient was lost during follow-up. Any statistically significant variation of blood perfusion was not observed in the control group (median PU at T0 and T24 respectively: fingertips 70, 71; periungual areas 68, 70; dorsum of hands 57, 57; palm of hands 59, 59; whole face 132, 130; p=n.s. for all areas).
Conclusions This study demonstrates that aminaphtone treatment seems able to increase skin blood perfusion and to improve RP symptoms, even in patients affected by systemic sclerosis. These preliminary results should be further confirmed by a randomized clinical trial, also to assess the role that aminaphtone plays in the treatment/prevention of disease clinical complications.
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Disclosure of Interest None declared