Session Information
Title: Systemic Sclerosis, Fibrosing Syndromes, and Raynaud’s - Clinical Aspects and Therapeutics II
Session Type: Abstract Submissions (ACR)
Background/Purpose: Phosphodiesterase-5 inhibitors have been successfully used for the treatment of Raynaud’s phenomenon (RP) in patients with systemic sclerosis (SSc). However, no study has evaluated the effect of these drugs in patients with early disease as well as on the number of endothelial progenitor cells (EPC) in SSc. The present study aimed to evaluate the effects of oral Sildenafil on the digital microvascular blood flow by means of Laser Doppler Imaging (LDI), in clinical features of RP, and in serum EPC levels in women with early SSc.
Methods: A randomized double-blind placebo controlled trial was conducted. Forty-one patients with RP secondary to SSc with less than 4 years of diagnosis (ACR criteria or LeRoy’s criteria for Early SSc), were randomly assigned to receive oral sildenafil 100mg/day (21 patients, mean age 47.2±10.9years) or placebo (20 patients, mean age 41.6±13.3years) for 8 weeks. Patients were evaluated at baseline (T0), after 8 weeks of treatment (T1), and 2 weeks after the end of the treatment (T2). The primary outcome was changes in finger blood flow (FBF) measured using LDI (Moor LDI-VR) before and for 30 minutes after cold stimulus (CS). FBF values were expressed in arbitrary perfusion units (PU). Secondary endpoints included serum levels of EPCs, frequency and duration of RP attacks, RP severity, and Raynaud’s Condition Score. EPCs were quantified by flow cytometry and identified by the co-expression of CD34, CD133 and vascular endothelial growth factor receptor type 2 (VEGFR2). The trial was registered on ClinicalTrials.com under the identifier NCT01347008.
Results: Basal FBF were similar between sildenafil and placebo groups (213.1±87.9 versus 256.0±119.5 PU, respectively; p=0.20) as well as in the different time-points after CS at T0. There was a significant increased in basal FBF in sildenafil group (FBF 260.0±108.0 PU; p=0.02), with no significant difference in placebo group (FBF 261.4±137.0 PU; p=1.00) after 8 weeks. There was also a significant increase in FBF values after CS in sildenafil group after 8 weeks of treatment (p<0.05), with no change in the placebo group. EPCs serum levels were similar between sildenafil and placebo groups before treatment (161.0±103.7 versus 156.6±97.5/106 lymphomononuclear cells, respectively; p=0.89). There were no significant changes in EPCs levels after treatment in both groups. There was a significant improvement in the duration of RP in the sildenafil group, as well as on RP severity after 8 weeks of treatment (p=0.010, p=0.031; respectively). All parameters returned to their basal values at T2. There was no significant difference in any clinical parameter evaluated in the placebo group along the study.
Conclusion: Oral Sildenafil showed to improve digital blood flow and RP symptoms in early SSc after 8 weeks of treatment, and may be a good therapeutic option for RP treatment in these patients.
Disclosure:
F. V. Andrigueti,
None;
P. C. C. Ebbing,
None;
M. I. Arismendi,
None;
C. Kayser,
None.
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ACR Meeting Abstracts - https://acrabstracts.org/abstract/evaluation-of-the-effect-of-sildenafil-on-the-microvascular-blood-flow-and-on-the-endothelial-progenitor-cells-in-patients-with-early-systemic-sclerosis-a-randomized-double-blind-placebo-controlled/