BAYESIAN HIERARCHICAL MODELING OF RANDOMIZED AND NON-RANDOMIZED STUDIES COMPARING CICLOSPORIN WITH IMMEDIATE- AND PROLONGED-RELEASE TACROLIMUS IN LIVER TRANSPLANT RECIPIENTS
Author(s)
Muduma G1, Pollock RF2, Odeyemi IA3, Saunders R2
1Astellas Pharma Europe Ltd, Chertsey, UK, 2Ossian Health Economics and Communications GmbH, Basel, Switzerland, 3Astellas Pharma EMEA, Chertsey, UK
OBJECTIVES: Several meta-analyses comparing ciclosporin with immediate-release (IR) tacrolimus have been conducted. Only recently have sufficient data become available for evidence synthesis including prolonged-release (PR) tacrolimus. In the present study, a network meta-analysis (NMA) was conducted to compare the efficacy of ciclosporin, IR and PR tacrolimus in liver transplant recipients. METHODS: Systematic literature review of PubMed, EMBASE and the Cochrane Library identified randomized controlled trials and large-scale observational studies (≥ RESULTS: Head-to-head study results were available for ciclosporin versus IR tacrolimus (n=14) and PR tacrolimus versus IR tacrolimus (n=2). Relative to ciclosporin, IR and PR tacrolimus were associated with reduced likelihood of death within 12 months of transplant (median odds ratios [OR] of 0.78 and 0.60, respectively). Mortality outcomes were superior with PR versus IR tacrolimus (median OR of 0.76). AR was less common with IR tacrolimus compared with ciclosporin (median OR of 0.69), whereas limited data for PR tacrolimus was evidenced by large credible intervals. There were no significant differences with respect to graft loss. Sensitivity analyses indicated that results were robust to assumptions and changes in confounders. Confounder analysis found that patient age was associated with death, whereas HCV status was associated with AR and graft loss. CONCLUSIONS: Patient and treatment factors beyond immunosuppressive treatment influence outcomes. Results of this confounder-controlled analysis provide further evidence that tacrolimus has substantial benefits over ciclosporin in liver transplant recipients. Compared with IR tacrolimus, data indicate that PR tacrolimus is superior with respect to patient survival.
Conference/Value in Health Info
2015-05, ISPOR 2015, Philadelphia, PA, USA
Value in Health, Vol. 18, No. 3 (May 2015)
Code
PGI2
Topic
Clinical Outcomes
Topic Subcategory
Comparative Effectiveness or Efficacy
Disease
Gastrointestinal Disorders