Comparing Outcomes Associated With Dose Manipulations of Enteric-Coated Mycophenolate Sodium Versus Mycophenolate Mofetil in Renal Transplant Recipients

Cooper, Matthew; Deering, Kathleen L.; Slakey, Douglas P.; Harshaw, Qing; Arcona, Stephen; McCann, Erin; Rasetto, F.; Florman, Sander

doi:10.1097/tp.0b013e3181b0e65e

Cited by 24 publications

(19 citation statements)

References 18 publications

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“…26,27 However, most of the BPAR were morphologically classified as borderline rejections. The most frequent adverse events were GI adverse effects (51%) (with Data are given as median and range.…”

Section: Discussionmentioning

confidence: 98%

Association Between Pharmacodynamic Biomarkers and Clinical Events in the Early Phase After Kidney Transplantation: A Single-Center Pilot Study

Wieland¹,

Shipkova²,

Martius³

et al. 2011

Therapeutic Drug Monitoring

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A potential benefit of pharmacodynamic monitoring to optimize immunosuppressive combination therapy has been demonstrated. In particular, CD26 and CD71 may be promising biomarkers to assess adequate immunosuppression in the early phase after kidney transplantation. The results of this pilot study require verification in further trials with more patients and events as well as with different graft types.

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Section: Discussionmentioning

confidence: 98%

Association Between Pharmacodynamic Biomarkers and Clinical Events in the Early Phase After Kidney Transplantation: A Single-Center Pilot Study

Wieland¹,

Shipkova²,

Martius³

et al. 2011

Therapeutic Drug Monitoring

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“…[60][61][62][63][64][65][66][67] Though designed specifically to improve GI adverse events, prospective randomized controlled studies did not find significant differences between the EC-MPS and MMF formulations. 60,65 However, MMF to EC-MPS conversion studies that implemented PRO measures consistently reported a significant improvement in patient-reported GI symptoms, [72][73][74] and in one study, increased numbers of patients were maintained on the maximum recommended EC-MPS dose.…”

Section: Resultsmentioning

confidence: 99%

“…A retrospective analysis by Cooper et al in 379 renal transplant recipients who were initiated on EC-MPS or MMF also found similar results. 64 Compared with MMF, the incidence of BPAR was significantly lower in the EC-MPS group (14% vs 23.1%, respectively). However, the incidence of GI complications (EC-MPS 52.8% vs MMF 48.9%) and patients requiring dose manipulation due to GI complication (EC-MPS 19.7% vs MMF 25.3%) was similar between groups.…”

Section: Clinical Efficacy De Novo Kidney Transplantmentioning

confidence: 99%

Mycophenolic acid agents: is enteric coating the answer?

Manitpisitkul¹,

Lee²,

Cooper³

2011

TRRM

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Addition of mycophenolate mofetil (MMF) to calcineurin-based immunosuppressive therapy has led to a significant improvement in graft survival and reduction of acute rejection in renal transplant recipients. However, in clinical practice, MMF dose reduction, interruption, or discontinuation due to hematological and gastrointestinal (GI) side-effects occurred in up to 50% of the patients. Large retrospective analyses have demonstrated that patients requiring MMF dose manipulation due to adverse events experienced a higher rate of rejection and graft loss. Enteric-coated mycophenolate sodium (EC-MPS) was developed with the goal of improving upper GI side-effects. Here, we review the efficacy and safety of EC-MPS in de novo kidney transplant recipient, and in stable renal transplant patients who were converted from MMF. The changes in GI-related adverse events using patient-reported outcome instruments are also reviewed.

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“…These disorders may be related to stress, infections, or exacerbation of pre-existing gastrointestinal pathology 10,11. In addition, immunosuppressive agents may cause gastrointestinal side effects, either directly or by favoring the development of bacterial or viral infection.…”

Section: Introductionmentioning

confidence: 99%

“…Severe gastrointestinal disorders may develop in approximately 10% of SOT patients, eventually leading to graft loss and even patient death. Gastrointestinal complications may also result in reduction of the dose of immunosuppressant drugs and associated risk of organ rejection 10,11. According to various studies of patient-reported gastrointestinal symptoms, the majority of patients complained of symptoms such as indigestion, abdominal pain, constipation, diarrhea, or reflux 12,13.…”

Section: Introductionmentioning

confidence: 99%

Increased Incidence of Endoscopic Erosive Esophagitis in Solid Organ Transplant Recipients

Kim¹,

Lee²,

Park³

et al. 2012

Gut Liver

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Background/AimsSolid organ transplant recipients frequently report gastrointestinal symptoms, especially heartburn or dyspepsia. However, the prevalence of endoscopic erosive esophagitis (EE) and associated risk factors after transplantation are unknown. The aim of this study was to determine whether there was a high incidence of endoscopic findings of EE in solid organ transplant recipients.MethodsThis retrospective case-control study included 256 of 3,152 solid organ transplant recipients who underwent sequential screening upper endoscopic examinations and an equal number of controls.ResultsForty-four (17.2%) and 16 (6.2%) cases of EE were detected in the solid organ transplant and control groups, respectively (p<0.001). In the multivariate analysis, transplantation was significantly associated with EE (odds ratio [OR], 6.48; 95% confidence interval, 2.74 to 15.35). Factors such as old age (OR, 1.17), the presence of a hiatal hernia (OR, 5.84), an increased duration of immunosuppression (OR, 1.07), and the maintenance administration of mycophenolate mofetil (OR, 4.13) were independently associated with the occurrence of EE in the solid organ transplant recipients.ConclusionsA significant increase in the incidence of endoscopically detected EE was observed in solid organ transplant recipients. This increased incidence was associated with the type and duration of the immunosuppressive therapy.

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Comparing Outcomes Associated With Dose Manipulations of Enteric-Coated Mycophenolate Sodium Versus Mycophenolate Mofetil in Renal Transplant Recipients

Cited by 24 publications

References 18 publications

Association Between Pharmacodynamic Biomarkers and Clinical Events in the Early Phase After Kidney Transplantation: A Single-Center Pilot Study

Association Between Pharmacodynamic Biomarkers and Clinical Events in the Early Phase After Kidney Transplantation: A Single-Center Pilot Study

Mycophenolic acid agents: is enteric coating the answer?

Increased Incidence of Endoscopic Erosive Esophagitis in Solid Organ Transplant Recipients

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