American Society of Hirudotherapy

Impact of Oral Eicosapentaenoic Acid on Veno-Occlusive Disease/Sinusoidal Obstruction Syndrome Onset Prevention: Single-Center Retrospective Analysis

Miyazaki Y, Narumi H, Azuma T, Tanimoto K, Masuda Y, Kato J, Konishi T, Nabe S, Maruta M, Ochi T, Yamanouchi J, Takenaka K (2025) · Transplantation and Cellular Therapy · n=138

RCT evidence detailTrial reference

Study Profile

Design
single-center retrospective analysis of 138 allogeneic HSCT in 123 patients (Ehime University Hospital, Japan, April 2008-June 2024)
Sample size (n)
138
Intervention
Oral eicosapentaenoic acid (EPA) 1800 mg/d divided into 2-3 doses + ursodeoxycholic acid post allo-HSCT (n=91)
Comparator
Ursodeoxycholic acid alone post allo-HSCT (n=47)
Primary endpoint
Incidence of VOD/SOS after allogeneic HSCT
Primary result
VOD/SOS occurred in 0 of 91 EPA recipients (0%) vs 3 of 47 non-EPA recipients (6.5%, p=0.014); no difference in 100-day post-transplant mortality between groups
Follow-up duration
Up to 100 days post-HSCT

Key Findings

  • 16-year single-center experience (138 transplants in 123 patients)
  • 0% VOD/SOS in EPA group vs 6.5% in non-EPA group (p=0.014)
  • EPA 1800 mg/d dose used in standard practice
  • No difference in early post-transplant mortality
  • Hypothesis-generating; warrants prospective trial

Limitations

  • Retrospective design with confounding by indication possible
  • Single-center experience limits generalizability
  • Small absolute event numbers (3 VOD/SOS cases)
  • Era effects across 16 years
  • Not applicable to whole-leech hirudotherapy

Clinical Implications

Miyazaki 2025 introduces oral EPA as a potentially low-cost, low-toxicity VOD/SOS prevention strategy worth further investigation. For ASH, this work illustrates how a nutritional supplement might serve as an alternative to pharmaceutical defibrotide, distinct from the K040187 device-leech US clinical practice but illustrative of broader principles of mechanistic prevention.

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