The Role of Proton Pump Inhibitors on Early Mycophenolic Acid Exposure in Kidney Transplantation: Evidence from the CLEAR Study.
Kiberd BA, Wrobel M, et al.Therapeutic Drug Monitoring, 33(1): 120-123, 2011.
Aims
To evaluate the impact of proton pump inhibitors (PPI) therapy on full mycophenolic acid (MPA) area under the curve exposures in kidney transplant recipients.
Interventions
Intensified dosing of mycophenolate mofetil (1.5g twice daily) versus standard dosing (1.0g twice daily). All recipients received tacrolimus and prednisone.
Participants
135 adult kidney transplant patients.
Outcomes
Full MPA area under the curve at day 5. The factors for univariate analysis included age, gender, serum creatinine, alumin and HLA antigen.
Follow-up
5 days post-transplant
CET Conclusions
In this sub-analysis from the CLEAR study, which compared 3 grams of MMF per day against 2 grams per day, the pharmacokinetics of MPA in patients who received proton pump inhibitors were analysed. It did not appear that PPI therapy in combination with MMF had any impact on full MPA exposure.
Data analysis
Modified intention-to-treat analysis
Quality notes
This is a sub-analysis of a previous publication of the same RCT: Gourishankar S, Houde I, Keown PA, et al. The CLEAR study: a 5-day 3-g loading dose of mycophenolate mofetil versus standard 2–3 dosing in renal transplantation. Clin J Am Soc Nephrol. 2010; 5:1282–1289. The methodological quality assessment was based on the previous publication.
Trial registration
NCT00788567(ClinicalTrials.gov)