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Abstract: TH-PO1108

Cardiovascular Safety of Hexasodium Phytate (SNF472) in Patients with CKD on Hemodialysis: A Systematic Review and Meta-Analysis

Session Information

Category: CKD (Non-Dialysis)

  • 2302 CKD (Non-Dialysis): Clinical, Outcomes, and Trials

Authors

  • Castro, Paulo de Coelho, Universidade de Sao Paulo, São Paulo, SP, Brazil
  • Estrela de Araújo, Luís Henrique, Faculdade de Ciencias Medicas da Paraiba, João Pessoa, PB, Brazil
  • Huntermann, Ramon, Centro Universitario para o Desenvolvimento do Alto Vale do Itajai, Rio do Sul, SC, Brazil
  • Gonçalves, Lívian Sousa, Universidade Nove de Julho, São Paulo, SP, Brazil
  • Kim Kim, Joo Young Belen, Universidad Nacional de Asuncion, San Lorenzo, Central Department, Paraguay
  • Carrera, Caroline Feu Rosa, Universidade de Sao Paulo, São Paulo, SP, Brazil
Background

Vascular calcification, characterized by pathological deposition of calcium-phosphate complexes in the vasculature, is a major complication in patients with chronic kidney disease (CKD). Calciphylaxis, a severe manifestation of vascular calcification, is associated with high mortality. Currently, treatment options for calciphylaxis are limited. SNF472, the hexasodium salt of myoinositol hexaphosphate, has emerged as a potential therapeutic agent for reducing vascular calcification.

Methods

We conducted, to our knowledge, the first systematic review and meta-analysis to evaluate the cardiovascular safety and efficacy of SNF472 in patients with CKD. The study protocol was registered in PROSPERO (CRD42024617721). A comprehensive search of PubMed, Embase, and Cochrane Central databases was performed.

Results

Five RCTs comprising 247 patients were included. The pooled prevalence of any treatment-emergent adverse event (AE) was 85.19% (95% CI: 72.98–92.45; I2 = 62.5%). AEs leading to treatment discontinuation occurred in 12.40% (95% CI: 5.72–24.83; I2 = 52.9%), while serious AEs were reported in 40.16% (95% CI: 26.51–55.53; I2 = 58.1%). The mortality rate during follow-up was 6.05% (95% CI: 1.19–25.57; I2 = 53.5%). SNF472 treatment was associated with a significant improvement in wound healing, by the BWAT-CUA (Bates-Jensen Wound Assessment Tool - Calciphylaxis Ulcer Assessment) (mean difference [MD]: -5.91; 95% CI: -8.17 to -3.65; I2 = 24.9%), and a reduction in pain scores assessed by the visual analog scale (VAS) (MD: -20.46; 95% CI: -28.05 to -12.87; I2 =0%).

Conclusion

SNF472 demonstrates a favorable cardiovascular safety profile and shows promising efficacy in enhancing wound healing and alleviating pain in patients with CKD. However, additional clinical trials with expanded patient populations are needed to further clarify its long-term safety and therapeutic benefit in this high-risk population.

Digital Object Identifier (DOI)