The impact of omeprazole on mycophenolate pharmacokinetics in kidney transplant recipients

Mohamed S AbdElhalim 1, Ahmed S Kenawy 1, Heba H El Demellawy 2, Amany A Azouz 3, Sarah S Alghanem 4, Torki Al-Otaibi 1, Osama Gheith 1 5, Mohamed Abd ElMonem 1, Mohammed K Afifi 1, Raghda R S Hussein 6

 

Affiliations

doi: 10.23876/j.krcp.20.059

Background: The absorption rates of mycophenolate mofetil (MMF) and enteric-coated mycophenolate sodium (EC-MPS) may be influenced by the concomitant use of omeprazole.

Methods: One hundred kidney transplant patients were recruited during their outpatient visits, including 50 on MMF and 50 on EC-MPS. At the clinic, a predose mycophenolic acid (MPA) sample (C0) was collected; subsequently, the participants received the proton-pump inhibitor omeprazole along with either MMF or EC-MPS. Two more blood samples were collected at 1.5 and 3.5 hours and used to estimate an area under the curve (AUC) from zero to 12 hours [AUC (0-12)].

Results: The mean number of months after transplant was 92 months. The median AUC (0-12) and C0 results were 62.2 mg·h/L and 2.0 mg/L for the MMF group and 71.9 mg·h/L and 1.8 mg/L for the EC-MPS group (P = 0.160 and 0.225, respectively). Interestingly, 54% of the MMF group and 62% of the EC-MPS group showed AUCs above the target values. The correlation between MPA C0 and the predicted AUC was poor in both groups.

Conclusion: Omeprazole can be safely co-administered with either MMF or EC-MPS, as it did not compromise the MPA exposure. Unexpectedly, however, a high percentage of patients presented MPA AUCs exceeding the target value, highlighting the importance of periodically assessing MPA level.

Keywords: Area under curve; Enteric-coated mycophenolate sodium; Kidney transplantation; Mycophenolate mofetil; Mycophenolic acid; Omeprazole.

Conflict of interest statement

Conflicts of interest

All authors have no conflicts of interest to declare.

Figures

Figure 1. The numbers and the percentage of recipients with MPA-AUC > 60 mg · hr/L to the total number of the recipients who receive equivalent doses. AUC, area under the curve; EC-MPS, enteric-coated mycophenolate sodium; MMF, mycophenolate mofetil; MPA, mycophenolic acid. aThe total number of patients who receive a specific dose of either MMF & EC-MPS. bThe number of patients who had AUC values of more than 60 mg·h/L (above the targeted AUC) of the same dose. MMF doses are 1,000 mg, 1,500 mg and 2,000 mg. EC-MPS doses are 720 mg, 1,080 mg and 1,440 mg. cNonsignificant difference between the two groups. dSignificant difference between the two groups.

Figure 1. The numbers and the percentage of recipients with MPA-AUC > 60 mg · hr/L to the total number of the recipients who receive equivalent doses. AUC, area under the curve; EC-MPS, enteric-coated mycophenolate sodium; MMF, mycophenolate mofetil; MPA, mycophenolic acid. aThe total number of patients who receive a specific dose of either MMF & EC-MPS. bThe number of patients who had AUC values of more than 60 mg·h/L (above the targeted AUC) of the same dose. MMF doses are 1,000 mg, 1,500 mg and 2,000 mg. EC-MPS doses are 720 mg, 1,080 mg and 1,440 mg. cNonsignificant difference between the two groups. dSignificant difference between the two groups.

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