Enteric-Coated Mycophenolate Sodium Reduces Gastrointestinal Symptoms in Renal Transplant Patients

Burg, M.E.L. van der; Säemann, Marcus D.; Wieser, C; Krämer, Stefan; Fischer, Wolfgang; Lhotta, Karl

doi:10.1016/j.transproceed.2009.08.078

Cited by 20 publications

(10 citation statements)

References 15 publications

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“…4,5 Due to the specially designed dosage form, EC-MPS delays the release of MPA in the small intestine, reducing the gastrointestinal burden and alleviating the gastrointestinal complications, and thus, it might lower the risk of rejection and graft loss because of the insufficient MPA exposure. 6–9 …”

Section: Introductionmentioning

confidence: 99%

Estimation of Mycophenolic Acid Area Under the Curve With Limited-Sampling Strategy in Chinese Renal Transplant Recipients Receiving Enteric-Coated Mycophenolate Sodium

Jia

Peng

et al. 2017

Therapeutic Drug Monitoring

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Background:The enteric-coated mycophenolate sodium (EC-MPS), whose active constituent is mycophenolic acid (MPA), has been widely clinically used for organ transplant recipients. However, its absorption is delayed due to its special designed dosage form, which results in difficulty to monitor the exposure of the MPA in patients receiving the EC-MPS. This study was aimed at developing a relatively practical and precise model with limited sampling strategy to estimate the 12-hour area under the concentration–time curve (AUC0–12 h) of MPA for Chinese renal transplant recipients receiving EC-MPS.Methods:A total of 36 Chinese renal transplant recipients receiving the EC-MPS and tacrolimus were recruited in this study. The time point was 2 weeks after the transplantation for all the patients. The MPA concentrations were measured with enzyme-multiplied immunoassay technique for 11 blood specimens collected predose and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, and 12 hours after the morning dose of EC-MPS. The measured AUC was calculated with these 11 points of MPA concentrations with the linear trapezoidal rule. Limited sampling strategy was used to develop models for estimated AUC in the model group (n = 18). The bias and precision of different models were evaluated in the validation group (n = 18).Results:C4 showed the strongest correlation with the measured AUC. The best 3 time point equation was 6.629 + 8.029 × C0 + 0.592 × C3 + 1.786 × C4 (R2 = 0.910; P < 0.001), whereas the best 4 time point equation was 3.132 + 5.337 × C0 + 0.735 × C3 + 1.783 × C4 + 3.065 × C8 (R2 = 0.959; P < 0.001). When evaluated in the validation group, the 4 time point model had a much better performance than the 3 time point model: for the 4 time point model: R2 = 0.873, bias = 0.505 [95% confidence interval (CI), −10.159 to 11.170], precision = 13.370 (95% CI, 5.186–21.555), and 77.8% of estimated AUCs was within 85%–115% of the measured AUCs; for the 3 time point model: R2 = 0.573, bias = 6.196 (95% CI, −10.627 to 23.018), precision = 21.286 (95% CI, 8.079–34.492), and 50.0% of estimated AUCs was within 85%–115% of the measured AUCs.Conclusions:It demanded at least 4 time points to develop a relatively reliable model to estimate the exposure of MPA in renal transplant recipients receiving the EC-MPS. The long time span needed restricted its application, especially for the outpatients, but it could be a useful tool to guide the personalized prescription for the inpatients.

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Section: Introductionmentioning

confidence: 99%

Estimation of Mycophenolic Acid Area Under the Curve With Limited-Sampling Strategy in Chinese Renal Transplant Recipients Receiving Enteric-Coated Mycophenolate Sodium

Jia

Peng

et al. 2017

Therapeutic Drug Monitoring

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“…In four studies, neither the method used to enrol participants nor the selection criteria were explicitly defined [21, 32, 38, 39]. There were ten studies that enrolled their population using methods that did not account for bias introduced from an intentionally skewed proportion of diseased individuals [20, 23, 25–29, 31, 41, 42]. The vast majority of studies limited sampling bias by clearly specifying the study population and by ensuring the sample was representative of the study population [18–20, 22–25, 27, 28, 30, 32–46].…”

Section: Resultsmentioning

confidence: 99%

Is Conversion from Mycophenolate Mofetil to Enteric-Coated Mycophenolate Sodium Justifiable for Gastrointestinal Quality of Life?

2018

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BackgroundGlobally, enteric-coated mycophenolate sodium (EC-MPS) is replacing mycophenolate mofetil (MMF) in maintenance immunosuppressant regimens. The predominant reason for conversion is the purported improvement in gastrointestinal (GI) quality of life. This paper considers the level of bias associated with studies comparing EC-MPS and MMF for GI-related improvement and provides insight into whether conversion is supported by evidence.MethodsUsing a pre-determined protocol, a literature search was conducted. Full-text review, data extraction and risk of bias analysis was conducted by two independent authors using the Cochrane domain-based evaluation of risk of bias. The review was reported according to the preferred reporting items for systematic reviews and meta-analyses.ResultsTwenty-nine studies were included in risk of bias analysis. Of these, only three were deemed a low risk of bias. Across these three studies, there were no statistically significant differences in the proportion of GI-related adverse events nor was there a significant difference in the GI-related quality of life between EC-MPS- and MMF-treated patients in these data.ConclusionThere was a high risk of bias across the 29 studies investigating conversion from MMF to EC-MPS for potential improvement in GI-related quality of life. The consolidated results of the three studies with low risk of bias suggest no evidence to convert patients stabilised on MMF. If a patient experiences GI-related adverse events whilst taking MMF, other methods should be explored before conversion to EC-MPS.Electronic supplementary materialThe online version of this article (10.1007/s40268-018-0254-8) contains supplementary material, which is available to authorized users.

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“… 4 , 9 Although the beneficial effect of switching from MMF to EC-MPS presents a common observation in graft recipients, there are findings demonstrating no significant clinical differences between these 2 MPA formulations. 16 - 18 …”

Section: Discussionmentioning

confidence: 99%

Celiac-like Enteropathy Associated With Mycophenolate Sodium in Renal Transplant Recipients

Filiopoulos

Sakellariou

Papaxoinis

et al. 2018

Transplantation Direct

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BackgroundAlthough colonic injury is a well-known complication of mycophenolic acid (MPA), the involvement of the upper gastrointestinal tract is less extensively documented. We present the occurrence of celiac-like duodenopathy manifested as a severe diarrhea syndrome in 2 renal transplant recipients on enteric-coated mycophenolate sodium.MethodsThe patients belong to a setting of 16 renal transplant recipients under MPA suffering from chronic diarrhea in the absence of MPA-related colitis.ResultsBoth patients had a history of persistent diarrhea with significant weight loss. Colonic mucosa was unremarkable, whereas duodenal biopsies revealed celiac-like changes with increased epithelial cell apoptosis. Clinical symptoms completely resolved, and follow-up biopsies demonstrated normalization of histology after enteric-coated mycophenolate sodium withdrawal and switching to azathioprine.ConclusionsCeliac-like enteropathy seems to represent a rare side effect of MPA-associated immunosuppressive therapy and should be taken into account in the differential diagnosis of diarrhea in transplant recipients treated with MPA particularly in the absence of MPA-related colitis. As macroscopic lesions are usually missing, blind duodenal biopsies are necessary to establish the diagnosis.

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Enteric-Coated Mycophenolate Sodium Reduces Gastrointestinal Symptoms in Renal Transplant Patients

Cited by 20 publications

References 15 publications

Estimation of Mycophenolic Acid Area Under the Curve With Limited-Sampling Strategy in Chinese Renal Transplant Recipients Receiving Enteric-Coated Mycophenolate Sodium

Estimation of Mycophenolic Acid Area Under the Curve With Limited-Sampling Strategy in Chinese Renal Transplant Recipients Receiving Enteric-Coated Mycophenolate Sodium

Is Conversion from Mycophenolate Mofetil to Enteric-Coated Mycophenolate Sodium Justifiable for Gastrointestinal Quality of Life?

Celiac-like Enteropathy Associated With Mycophenolate Sodium in Renal Transplant Recipients

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