Randomized trial of steroid free immunosuppression with basiliximab induction in adult live donor liver transplantation (LDLT)
| Autor: | Dinesh Balakrishnan, Shweta Mallick, Pulkit Sethi, Manikandan kathirvel, Aleena Sunny, Biju Chandran, M.S. Durairaj, Binoj Sivasankara Pillai Thankamony Amma, Krishnanunni Nair, Christi Titus Varghese, Ramachandran Narayana Menon, Unnikrishnan Gopalakrishnan, Johns Shaji Mathew, Sudhindran Surendran, Manoj Thillai |
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| Rok vydání: | 2021 |
| Předmět: |
Adult
Graft Rejection medicine.medical_specialty Basiliximab Recombinant Fusion Proteins medicine.medical_treatment Azathioprine Liver transplantation Gastroenterology 03 medical and health sciences 0302 clinical medicine Diabetes mellitus Internal medicine Living Donors medicine Clinical endpoint Humans Immunosuppression Therapy Hepatology business.industry Immunosuppression medicine.disease Kidney Transplantation Tacrolimus Liver Transplantation Regimen surgical procedures operative 030220 oncology & carcinogenesis Steroids 030211 gastroenterology & hepatology business Immunosuppressive Agents medicine.drug |
| Zdroj: | HPB. 23:666-674 |
| ISSN: | 1365-182X |
| Popis: | Background Corticosteroids are an integral part of immunosuppression following solid organ transplantation, despite their metabolic complications. We conducted a randomized trial to evaluate the efficacy of steroid-free immunosuppression following live donor liver transplantation (LDLT). Methods We randomized 104 patients stratified based on pre-transplant diabetic status to either a steroid-free arm (SF-arm) (Basiliximab + Tacrolimus and Azathioprine,n = 52) or Steroid arm (S-Arm) (Steroid + Tacrolimus + Azathioprine,n = 52). The primary endpoint was the occurrence of metabolic complications (new-onset diabetes after transplant (NODAT), new-onset systemic hypertension after transplant (NOSHT), post-transplant dyslipidemia) within 6 months after transplant. Secondary endpoints included biopsy-proven acute rejection (BPAR) within six months, patient and graft survival at 6 months. Results The incidence NODAT was significantly higher in S-arm at 3 months (64.5%vs. 28.1%,p-0.004) and 6 months (51.6% vs. 15.6%,p-0.006). Likewise, the incidence of NOSHT (27.8% vs. 4.8%,p-0.01) and hypertriglyceridemia (26.7% vs. 8%,p-0.03) at six months was significantly higher in S-arm. However, there were no differences in BPAR (19.2% vs. 21.2%, p-0.81), time to first rejection (58 vs. 53 days, p-0.78), patient and graft survival (610 vs. 554 days,p- 0.22). Conclusion Following LDLT, basiliximab induction with tacrolimus and azathioprine maintenance resulted in significantly lower metabolic complications compared to the triple-drug regimen of steroid, tacrolimus, and azathioprine. |
| Databáze: | OpenAIRE |
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