A prospective, randomized trial of complete avoidance of steroids in liver transplantation with follow-up of over 7 years.
Pelletier SJ, Nadig SN, et al.International Hepato-Pancreato-Biliary Association (HPB) 2013; 15(4): 286-293.
Aims
To assess the efficacy of complete steroid avoidance in liver transplant recipients.
Interventions
Patients were randomised to receive either standard therapy with steroids or standard therapy with steroid avoidance. The steroid group received tacrolimus, mycophenolate mofetil (MMF) and one dose of dexamthasone 50mg intraoperatively followed by a 3-6 month taper of prednisone. The non-steroid group received the same standard immunosupression therapy as the steroid group but without steroids.
Participants
100 adult patients undergoing liver transplantation.
Outcomes
Primary outcomes included: patient and graft survival and biopsy proven rejection. Secondary outcomes included: hepatitis C recurrence and postoperative metabolic, infectious and transplant-specific complications.
Follow-up
2095±117 days
CET Conclusions
This manuscript reports long-term follow-up of a trial originally run between 2002 and 2005. Unlike other trials and recent systematic reviews of steroid sparing/avoidance, very little benefit in terms of metabolic parameters was seen with steroid avoidance (although these results are only reported to one year). Whilst there was no increase in the risk of acute rejection with steroid avoidance, there was a significant increase in re-transplant rate. What is of most interest here is the long-term survival data, which shows a trend towards increased graft loss and patient death in those patients completely avoiding steroids. This shows the importance of long-term follow-up of clinical trials. These results do not achieve statistical significance due to a lack of power, so this finding would have to be validated in further studies.
Data analysis
Available case analysis
Trial registration
Not reported.