Enteric Coated Mycophenolate Sodium is Therapeutically Equivalent to Mycophenolate Mofetil in de novoRenal Transplant Patients

Salvadori, Maurizio; Holzer, Herwig; Mattos, Angelo de; Sollinger, Hans W.; Arns, Wolfgang; Oppenheimer, Federico; Maca, Jeff; Hall, Michael

doi:10.1046/j.1600-6143.2003.00337.x

Cited by 288 publications

(221 citation statements)

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“…The overall results of this study clearly confirm that EC-MPS is as safe and as effective as MMF, and thus are in agreement with previous findings in de novo transplant patients (11). With the exception of the incidence of serious infections, no statistically significant differences between EC-MPS and MMF were identified in the safety and efficacy parameters measured.…”

Section: Discussionsupporting

confidence: 91%

Enteric-Coated Mycophenolate Sodium can be Safely Administered in Maintenance Renal Transplant Patients: Results of a 1-Year Study

Budde

Curtis

Knoll

et al. 2004

American Journal of Transplantation

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With the objective of enhancing upper gastrointestinal (GI) tolerability, enteric-coated mycophenolate sodium (EC-MPS, myfortic0.47; p = = NS). Neutropenia (< <1500 cells/mm 3 ) within the first 3 months (coprimary endpoint) was low in both groups (EC-MPS 0.6%; MMF 3.1%; p = = NS). Although the overall incidence of infections was similar, the number of serious infections was significantly lower in EC-MPS patients (8.8% vs. 16.0%; p < < 0.05). Similar rates of efficacy failure (EC-MPS 2.5%; MMF 6.1%; p = = NS), biopsy-proven acute rejection (EC-MPS 1.3%; MMF 3.1%; p = = NS) and biopsy-proven chronic rejection (EC-MPS 3.8%; MMF 4.9%; p = = NS) were observed in both groups. In conclusion, renal maintenance patients can be converted from MMF to EC-MPS without compromising the safety and efficacy profile associated with MMF.

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Section: Discussionsupporting

confidence: 91%

Enteric-Coated Mycophenolate Sodium can be Safely Administered in Maintenance Renal Transplant Patients: Results of a 1-Year Study

Budde

Curtis

Knoll

et al. 2004

American Journal of Transplantation

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240

157

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“…Only four induction studies [71][72][73][74] and six maintenance studies 58,[124][125][126][127]150 adequately addressed five or more of the 10 items of the quality appraisal assessment. However, even the reports of these trials omitted important information relating to quality, with six [71][72][73][74]124,125 of the seven failing to clearly describe the procedure used for allocation concealment, and one 58 failing to include an intention-to-treat (ITT) analysis.…”

Section: Overall Assessmentmentioning

confidence: 99%

“…However, even the reports of these trials omitted important information relating to quality, with six [71][72][73][74]124,125 of the seven failing to clearly describe the procedure used for allocation concealment, and one 58 failing to include an intention-to-treat (ITT) analysis.…”

Section: Overall Assessmentmentioning

confidence: 99%

Immunosuppressive therapy for kidney transplantation in adults: a systematic review and economic model

Jones-Hughes

Snowsill

Haasova

et al. 2016

Health Technol Assess

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BackgroundEnd-stage renal disease is a long-term irreversible decline in kidney function requiring renal replacement therapy: kidney transplantation, haemodialysis or peritoneal dialysis. The preferred option is kidney transplantation, followed by immunosuppressive therapy (induction and maintenance therapy) to reduce the risk of kidney rejection and prolong graft survival.ObjectivesTo review and update the evidence for the clinical effectiveness and cost-effectiveness of basiliximab (BAS) (Simulect®, Novartis Pharmaceuticals UK Ltd) and rabbit anti-human thymocyte immunoglobulin (rATG) (Thymoglobulin®, Sanofi) as induction therapy, and immediate-release tacrolimus (TAC) (Adoport®, Sandoz; Capexion®, Mylan; Modigraf®, Astellas Pharma; Perixis®, Accord Healthcare; Prograf®, Astellas Pharma; Tacni®, Teva; Vivadex®, Dexcel Pharma), prolonged-release tacrolimus (Advagraf®Astellas Pharma), belatacept (BEL) (Nulojix®, Bristol-Myers Squibb), mycophenolate mofetil (MMF) (Arzip®, Zentiva; CellCept®, Roche Products; Myfenax®, Teva), mycophenolate sodium (MPS) (Myfortic®, Novartis Pharmaceuticals UK Ltd), sirolimus (SRL) (Rapamune®, Pfizer) and everolimus (EVL) (Certican®, Novartis) as maintenance therapy in adult renal transplantation.MethodsClinical effectiveness searches were conducted until 18 November 2014 in MEDLINE (via Ovid), EMBASE (via Ovid), Cochrane Central Register of Controlled Trials (via Wiley Online Library) and Web of Science (via ISI), Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effects and Health Technology Assessment (The Cochrane Library via Wiley Online Library) and Health Management Information Consortium (via Ovid). Cost-effectiveness searches were conducted until 18 November 2014 using a costs or economic literature search filter in MEDLINE (via Ovid), EMBASE (via Ovid), NHS Economic Evaluation Database (via Wiley Online Library), Web of Science (via ISI), Health Economic Evaluations Database (via Wiley Online Library) and the American Economic Association’s electronic bibliography (via EconLit, EBSCOhost). Included studies were selected according to predefined methods and criteria. A random-effects model was used to analyse clinical effectiveness data (odds ratios for binary data and mean differences for continuous data). Network meta-analyses were undertaken within a Bayesian framework. A new discrete time–state transition economic model (semi-Markov) was developed, with acute rejection, graft function (GRF) and new-onset diabetes mellitus used to extrapolate graft survival. Recipients were assumed to be in one of three health states: functioning graft, graft loss or death.ResultsEighty-nine randomised controlled trials (RCTs), of variable quality, were included. For induction therapy, no treatment appeared more effective than another in reducing graft loss or mortality. Compared with placebo/no induction, rATG and BAS appeared more effective in reducing biopsy-proven acute rejection (BPAR) and BAS appeared more effective at improving GRF. For maintenance therapy, no treatment was better for all outcomes and no treatment appeared most effective at reducing graft loss. BEL + MMF appeared more effective than TAC + MMF and SRL + MMF at reducing mortality. MMF + CSA (ciclosporin), TAC + MMF, SRL + TAC, TAC + AZA (azathioprine) and EVL + CSA appeared more effective than CSA + AZA and EVL + MPS at reducing BPAR. SRL + AZA, TAC + AZA, TAC + MMF and BEL + MMF appeared to improve GRF compared with CSA + AZA and MMF + CSA. In the base-case deterministic and probabilistic analyses, BAS, MMF and TAC were predicted to be cost-effective at £20,000 and £30,000 per quality-adjusted life-year (QALY). When comparing all regimens, only BAS + TAC + MMF was cost-effective at £20,000 and £30,000 per QALY.LimitationsFor included trials, there was substantial methodological heterogeneity, few trials reported follow-up beyond 1 year, and there were insufficient data to perform subgroup analysis. Treatment discontinuation and switching were not modelled.Future workHigh-quality, better-reported, longer-term RCTs are needed. Ideally, these would be sufficiently powered for subgroup analysis and include health-related quality of life as an outcome.ConclusionOnly a regimen of BAS induction followed by maintenance with TAC and MMF is likely to be cost-effective at £20,000–30,000 per QALY.Study registrationThis study is registered as PROSPERO CRD42014013189.FundingThe National Institute for Health Research Health Technology Assessment programme.

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“…Both are increasingly used as immunomodulators in diseases such as atopic dermatitis, pemphigus vulgaris, rheumatoid arthritis, lupus nephritis, vasculitis, various glomerular diseases, myasthenia gravis, thrombocytopenic purpura and human immunodeficiency virus infection. 5,6 Despite the lack of adequate drug monitoring methods and several studies showing significant differences in therapeutic efficacy and tolerability among patients, and claiming that several patients do not or only poorly benefit from MPA therapy, 7,8 MPA has gained widespread acceptance as part of standard immunosuppressive regimens. Accumulating evidence from pharmacokinetic and pharmacodynamic studies shows the necessity to consider individualization of MPA treatment.…”

Section: Introductionmentioning

confidence: 99%

An inosine 5′-monophosphate dehydrogenase 2 single-nucleotide polymorphism impairs the effect of mycophenolic acid

et al. 2009

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Mycophenolic acid (MPA) is a selective inhibitor of inosine 5 0 -monophosphate dehydrogenase (IMPDH), the rate-limiting enzyme of de novo synthesis of guanine nucleotides. The isoenzyme IMPDH2 predominates in activated lymphocytes, and its inhibition by MPA is part of standard immunosuppressive regimens. Yet, there are significant unexplained differences in efficacy and tolerability among patients. The objective of this study was to analyze whether frequent variants in the IMPDH2 gene lead to changes in IMPDH activity and to differences in responsiveness to MPA therapy. All 14 exons and intron-exon boundary regions of IMPDH2 were sequenced from genomic DNA probes from 100 healthy individuals. Two novel exonic single-nucleotide polymorphisms were identified in 1% and one intronic polymorphism (rs11706052) in 19% of the study population. Lymphocyte IMPDH activity and proliferation under three MPA concentrations (2.5, 10 and 25 mmol l -1 ) were compared in rs11706052 carriers and wild-type individuals. The presence of rs11706052 polymorphism reduced the antiproliferative effect of MPA on lymphocytes by approximately 50% compared with the IMPDH2 wild-type form at therapeutic relevant concentrations of 10 mmol l -1 and 25 mmol l -1 . We conclude that a poorer response to MPA therapy can be explained in some individuals by the presence of the rs11706052 polymorphism.

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Enteric Coated Mycophenolate Sodium is Therapeutically Equivalent to Mycophenolate Mofetil in de novoRenal Transplant Patients

Cited by 288 publications

References 10 publications

Enteric-Coated Mycophenolate Sodium can be Safely Administered in Maintenance Renal Transplant Patients: Results of a 1-Year Study

Enteric-Coated Mycophenolate Sodium can be Safely Administered in Maintenance Renal Transplant Patients: Results of a 1-Year Study

Immunosuppressive therapy for kidney transplantation in adults: a systematic review and economic model

An inosine 5′-monophosphate dehydrogenase 2 single-nucleotide polymorphism impairs the effect of mycophenolic acid

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