A SYSTEMATIC REVIEW OF IMMUNOSUPPRESSIVE REGIMENS IN LOWER IMMUNOLOGICAL RISK RENAL TRANSPLANT RECIPIENTS

Author(s)

Kang MH, Kim HJ, Ko RK, Ko SKPfizer Pharmaceuticals Korea Ltd, Seoul, South Korea

OBJECTIVES: In this study, we conducted a systematic review of three immunosuppressive regimens in lower risk renal transplantation and compared their efficacy. METHODS: MEDLINE were searched and two independent reviewers assessed studies. We limited the search to English, Randomized controlled trial, Human and publication between January 1, 1999~May 31, 2010. Studies which were conducted with adult renal transplant patients (>18 years) with lower immunological risk were included. Sirolimus + steroid regimen with 3 months cyclosporine, and CNI (Calcineurin inhibitor: cyclosporine or tacrolimus) regimen with MMF and steroid were eligible for inclusion. A total of 434 studies were retrieved from MEDLINE firstly. By reviewing title, abstracts and full text, 10 studies were eligible for the inclusion finally. As outcome data, we extracted patient survival and graft survival. RESULTS: There was no head-to-head clinical trial which compared the three regimens concurrently. But results from 2 studies shows trend of higher patient and graft survival with low dose CNI regimen than standard dose cyclosporine. ELITE-Symphony Study illustrated patient and graft survival of 96.5% and 89.3% for standard dose cyclosporine, 98.2% and 93.1% for low dose cyclosporine, 97.2% and 94.2% for low dose tacrolimus at 1year. And CAESAR Study showed 97.1% and 92.4% for standard dose cyclosporine, 97.8% and 94.5% for low dose cyclosporine at 1year. 5 reports from ‘Rapamune Maintenance Regimen Study’ showed outcomes for sirolimus based regimen during 5 years. At 1 year, patient and graft survival were 98.1% and 97.2% and decreased thereafter. One study of tacrolimus based regimen reported 2-year patient and graft survival of 92.9% and 92.4% for biopsy arm, 97.9% and 94.1% for control arm. Both of the treatment arms were standard dose tacrolimus regimen. CONCLUSIONS: Three of immunosuppressive regimens are considered to have similar efficacy in short-term patient and graft survival in lower immunological risk renal transplant patients.

Conference/Value in Health Info

2010-11, ISPOR Europe 2010, Prague, Czech Republic

Value in Health, Vol. 13, No. 7 (November 2010)

Code

PUK4

Topic

Clinical Outcomes

Topic Subcategory

Comparative Effectiveness or Efficacy

Disease

Urinary/Kidney Disorders

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