Aminaphtone Efficacy in Primary and Secondary Raynaud's Phenomenon: A Feasibility Study

Abstract

Objectives: The aim of this six-month open feasibility study was to evaluate skin blood perfusion and clinical symptom changes during aminaphtone treatment in patients with either primary or secondary Raynaud's phenomenon to systemic sclerosis.

Methods: Ninety-two patients referring for Raynaud's phenomenon have been enrolled in November during routine clinical assessment, after informed consent. Aminaphtone was administered 75 mg twice daily in addition to current treatments to forty-six patients. Skin blood perfusion was measured by Laser Speckle Contrast Analysis (LASCA) at the level of fingertips, periungual areas, dorsum and palm of hands, and face at baseline (W0), after one (W1), four (W4), twelve (W12) and twenty-four (W24) weeks of treatment. Raynaud's condition score (RCS) and both frequency and duration of Raynaud's attacks were assessed at the same time.

Results: Compared with the control group, despite colder period of the year, aminaphtone treated patients showed a progressive statistically significant increase of blood perfusion, as well as a decrease of RCS, frequency of Raynaud's attacks/day and their duration, from W0 to W12 in all skin areas. From W12 to W24 no further increase of blood perfusion was observed. The results were similar in both primary and secondary Raynaud's phenomenon patients. Five weeks after aminaphtone discontinuation blood perfusion values were significantly higher than those at baseline in the majority of skin areas.

Conclusion: This study demonstrates that aminaphtone treatment increases skin blood perfusion and improves Raynaud's phenomenon clinical symptoms, with sustained efficacy up to 6 months, even in patients with systemic sclerosis. A randomized, blind, controlled, clinical trial including a larger number of subjects is advisable to confirm these early results.

Keywords: Raynaud condition score; Raynaud phenomenon; aminaphtone; blood perfusion; clinical symptoms; laser speckle contrast analysis; microcirculation; systemic sclerosis.

FIGURE 1

Assessment of blood perfusion. Example of evaluation of blood perfusion by LASCA technique at the level of dorsal (A) and palmar (B) aspect of hands, respectively, at baseline (W0), after one (W1), four (W4), twelve (W12) and twenty-four (W24) weeks of treatment with aminaphtone in patient F.B. (Blue color = low blood perfusion, yellow color = intermediate blood perfusion, red color = high blood perfusion (White circles = regions of interest for perfusion measuring at the level of dorsum, periungual, palm and fingertip areas).

FIGURE 2

Blood perfusion and clinical trends during aminaphtone treatment. Variation of blood perfusion (BP) in six skin areas from baseline (W0) to twenty-four (W24) weeks during aminaphtone treatment, and after one (W25) and five (W29) weeks since treatment discontinuation, in all patients with Raynaud’s phenomenon. Variation of Raynaud Condition Score (RCS), Raynaud’s frequency (number of daily attacks) and duration (minutes) are also reported. Charts report means along with standard deviation values (PU = perfusion units). See Table 2 for statistical significances.

FIGURE 3

Structure formula of aminaphtone (C18-H15-N-O4).