Analysis of death avoidance by concomitant use of prednisone in patients with renal transplant using the Food and Drug Administration Adverse Event Reporting System

Abstract

Background: Patients with renal transplant are frequently administered immunosuppressants to prevent transplant-related adverse events. There are mainly nine immunosuppressants on the market, and multiple immunosuppressants are frequently administered for patients with renal transplant. Identifying which immunosuppressant was responsible when efficacy or safety was observed in patients taking multiple immunosuppressants is difficult. This study aimed to identify the immunosuppressant that was effective in reducing death in patients with renal transplant. A very large sample size was required to conduct prospective clinical trials of immunosuppressant combinations, which is impractical. We investigated cases wherein death occurred despite immunosuppressant administration in patients with renal transplant using Food and Drug Administration Adverse Event Reporting System (FAERS) data.

Material and method: We used FAERS data reported between January 2004 and December 2022 in patients with renal transplant who received one or more immunosuppressants. Groups were defined for each combination of immunosuppressants. Comparison between two identical groups except for the presence or absence of prednisone was performed using the reporting odds ratio (ROR) and the adjusted ROR (aROR) controlling for differences in patient background.

Results: When the group without prednisone was set as the reference, the aROR for death was significantly <1.000 in several cases in the group to which prednisone was added.

Conclusions: The inclusion of prednisone in the immunosuppressant combinations was suggested to be effective in reducing death. We provided the sample code of software R that can reproduce the results.

Keywords: Death; Food and Drug Administration Adverse Event Reporting System; Prednisone; Renal transplant.