Donor Simvastatin Treatment is Safe and Might Ameliorate Outcomes after Liver Transplantation: A Randomized Phase II Double-Blind Clinical Trial

Introduction: Liver transplantation (LT) is currently the only curative therapy for end- stage liver disease (ESLD). We present the SIMVAstatin donor treatment before Liver Transplants (SIMVALT) study. Methods: SIMVALT is a monocentric, double-blind, randomized, prospective trial comparing the safety and efficacy of preoperative deceased brain donors’ treatment with the intra-gastric administration of 80 mg of simvastatin on liver transplant recipient outcomes in a real-life setting. Primary aim was incidence of patient and graft survival at 90 and 180 days post-transplant; secondary end-points were severe complications. Results: The trial enrolled 58 adult patients (18-65 years-old). The minimum follow-up was 6-month. No patient or graft were lost at 90 or 180 days in the Experimental Group (n = 27), while patient/graft survival were 89.7% (p = 0.0804) and 86.2% (p = 0.0415) at 90-day, and 93.1% (p = 0.1572) and 86.2% (p = 0.0415) at 180-day in the Control Group (n = 29). The percentage of patients with severe complication (Clavien-Dindo≥IIIb) was higher in the Control Group, 55.2% Vs 25.0% in the Experimental Group (p = 0.0307). There only significant differences in liver tests was a significantly higher gamma-glutamyl transferase and alkaline phosphatase at 15 days (p = 0.017), (p = 0.015) in the simvastatin group. Conclusion: Donor simvastatin treatment is safe, and may significantly improve early graft and patient survival after LT, although further research is mandatory. Trial Registry number: ISRCTN27083228.