Pharmacokinetic (PK) data show reduced mycophenolic acid levels in transplant recipients taking mycophenolate mofetil (MMF) and proton pump inhibitors (PPIs) concomitantly. MMF dosing is not standardized and varies by transplant center. Prior studies have failed to show significant acute rejection differences for patients taking MMF-PPI versus MMF-ranitidine. This study evaluated clinical outcomes in renal transplant recipients receiving 1.5 grams daily of MMF (a lower dose than previously studied) and either a PPI or histamine-2 receptor antagonist (H2RA).

This retrospective cohort study evaluated adult subjects receiving a renal transplant between January 1, 2009 and June 30, 2013. Inclusion criteria consisted of patients who received per-protocol induction and maintenance immunosuppression (which included MMF). Follow-up was 12 months or up to patient death (within 12 months). Exclusion criteria included multi-organ transplantation or index hospital admission death or acute rejection. Cohorts were developed based upon discharge acid-suppressing therapy, and between-group comparisons were made using inferential statistics. A multivariable logistic regression analysis was performed and included the following covariates: PPI exposure, female sex, black race, recipient age ≤50 years, donor age ≥65 years, receipt of a deceased donor kidney, panel reactive antibodies ≥20%, basiliximab induction, and delayed graft function.

Of 728 recipients screened, 522 were included: 183 receiving a PPI and 339 an H2RA. There were significantly more females in the PPI group and significantly more H2RA subjects who received basiliximab induction. Other transplant-specific characteristics were similar between groups. There was no significant difference in rejection at one-year (H2RA 19% versus PPI 14%, p=0.12) or three-months (4% versus 5%, p=0.44). Graft and patient survival were favorable (>95%), and one-year graft function was similar between groups. While PPI use was not an independent predictor of any rejection within one-year post-transplant on multivariable logistic regression analysis, receipt of a deceased donor kidney was significant for this outcome (OR=1.85, p=0.03). Overall, the PK interaction between MMF and PPIs did not impact graft and patient outcomes at one-year for recipients taking lower MMF doses.

CITATION INFORMATION: Patel K, Stephany B, Barnes J, Bauer S, Spinner M. Concomitant Proton Pump Inhibitor and Mycophenolate Mofetil Use in Renal Transplant Recipients. Am J Transplant. 2016;16 (suppl 3).

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