Bioequivalence of enteric-coated mycophenolate sodium and mycophenolate mofetil: a meta-analysis of three studies in stable renal transplant recipients.


BACKGROUND:Mycophenolic acid (MPA) is an inhibitor of lymphocyte proliferation and is well established as an immunosuppressive agent in solid organ transplantation. The initial formulation of the drug was a prodrug formulation, mycophenolate mofetil (MMF, Cellcept), which is well absorbed and rapidly converted to mycophenolate in plasma. However, the use of MMF is associated with adverse gastrointestinal events, which can lead to withdrawal of therapy. In an effort to reduce the gastrointestinal effects of MMF, an enteric-coated formulation of the drug was developed, based on the sodium salt of MPA (EC-MPS, Myfortic). METHODS:Although bioequivalence has been demonstrated in an individual study in maintenance kidney transplant patients, this manuscript documents bioequivalence in a much larger data set of 82 patients by a meta-analysis of data from clinical trials. RESULTS:The results confirm the bioequivalence of EC-MPS and MMF for both mycophenolate and metabolite exposure, and for maximum plasma mycophenolate concentrations, across three studies. The 90% confidence interval of the ratio of EC-MPS to MMF for mycophenolate plasma AUC in the 82 patients was 101.1 to 114.5% and for Cmax was 83.0% to 112.7%. CONCLUSION:These findings provide reassurance to transplant professionals and patients that, when choosing between EC-MPS and MMF, they are choosing between formulations that give equivalent mycophenolate exposure.






Johnston A,He X,Holt DW




Has Abstract


2006-12-15 00:00:00














  • The relationship between flow cytometer crossmatch results and subsequent rejection episodes in cadaver renal allograft recipients.

    abstract::Flow cytometry (FC) T and B cell crossmatches were done retrospectively for 38 cadaver renal transplant recipients (29 first and 9 retransplants--minimum follow-up 12 months) using both current pretransplant serum and peak-reactive sera. An increase in median fluorescence intensity (channel shift) and/or an increase i...


    pub_type: 杂志文章


    authors: Lazda VA,Pollak R,Mozes MF,Jonasson O

    更新日期:1988-03-01 00:00:00

  • Tacrolimus trough level at discharge predicts acute rejection in moderately sensitized renal transplant recipients.

    abstract:BACKGROUND:Goal tacrolimus concentrations for the prevention of rejection in sensitized renal transplant recipients are not well established. METHODS:We evaluated the association between discharge tacrolimus trough concentration and the incidence of biopsy-proven acute rejection (BPAR) in 216 moderately sensitized ren...


    pub_type: 杂志文章


    authors: Richards KR,Hager D,Muth B,Astor BC,Kaufman D,Djamali A

    更新日期:2014-05-27 00:00:00

  • National sharing of cadaveric isolated intestinal allografts for human transplantation: a feasibility study.

    abstract:UNLABELLED:Most isolated intestinal graft losses are immunological. We conducted a pilot study to evaluate the feasibility of national sharing of HLA no-mismatch allografts for cadaveric isolated intestinal transplantation. METHODS:UNOS data were analyzed in a theoretical model. Part I: All solid organ donors between ...


    pub_type: 杂志文章


    authors: Fishbein TM,Bodian CA,Miller CM

    更新日期:2000-03-15 00:00:00

  • A suppressive effect of cyclosporine A on replication and noncoding control region activation of polyomavirus BK virus.

    abstract:BACKGROUND:The effect of cyclosporine A (CsA) on polyomavirus BK virus (BKV) replication remains unclear. The aim of this in vitro study was to investigate the effect of CsA on BKV replication in human uroepithelial cells. METHODS:After infection of a human renal proximal tubular cell line, HK-2 with BKV, BKV viral lo...


    pub_type: 杂志文章


    authors: Li YJ,Weng CH,Lai WC,Wu HH,Chen YC,Hung CC,Yang CW,Tian YC

    更新日期:2010-02-15 00:00:00

  • Lung rejection occurs in lung transplant recipients with blood chimerism.

    abstract:BACKGROUND:It has been postulated that chimerism after transplantation might promote graft acceptance. In the present study, we prospectively assessed blood chimerism in 10 lung transplant recipients during the first posttransplant year and investigated whether chimerism was associated with an immunologically stable si...


    pub_type: 杂志文章


    authors: Knoop C,Andrien M,Defleur V,Antoine M,de Francquen P,Goldman M,Estenne M

    更新日期:1997-07-15 00:00:00

  • Early induction of immune resistance against leukemia in mice after lethal irradiation followed by syngeneic bone marrow transplantation and injection of syngeneic leukocytes.

    abstract::BALB/cxDBA/2Wf F1 (CD2F1) mice were lethally irradiated and reconstituted with syngeneic bone marrow cells untreated or treated with 75 micrograms/ml of mafosfamide. One day after bone marrow transplantation some groups of mice were injected with syngeneic splenocytes, peripheral blood leukocytes, or thymocytes. Seven...


    pub_type: 杂志文章


    authors: Skórski T,Kawalec M,Kawiak J

    更新日期:1991-04-01 00:00:00

  • Removal of anti-porcine natural antibodies from human and nonhuman primate plasma in vitro and in vivo by a Galalpha1-3Galbeta1-4betaGlc-X immunoaffinity column.

    abstract:BACKGROUND:Natural antibodies (NAbs) against a terminal alpha1-3 galactosyl (alphaGal) epitope have been identified as the major human anti-pig NAbs. METHODS AND RESULTS:We used two synthetic alphaGal trisaccharides--type 6 (alphaGal6) and type 2(alphaGal2)--linked to an inert matrix to remove NAbs from human plasma i...


    pub_type: 杂志文章


    authors: Xu Y,Lorf T,Sablinski T,Gianello P,Bailin M,Monroy R,Kozlowski T,Awwad M,Cooper DK,Sachs DH

    更新日期:1998-01-27 00:00:00

  • Liver Transplantation of HCV-Viremic Donors into HCV-Negative Recipients in the USA: Increasing Frequency with Profound Geographic Variation.

    abstract:BACKGROUND & AIMS:Direct-acting antiviral (DAA) therapy made possible the novel practice of utilizing HCV-viremic (HCV-RNA-positive) donors into HCV-negative recipients in the United States. Although initial reports of outcomes have been satisfactory, higher-quality longer-term outcomes remain to be elucidated. METHOD...


    pub_type: 杂志文章


    authors: Cotter TG,Aronsohn A,Reddy KG,Charlton M

    更新日期:2020-06-29 00:00:00

  • Rapamycin Prolongs Graft Survival and Induces CD4+IFN-γ+IL-10+ Regulatory Type 1 Cells in Old Recipient Mice.

    abstract:BACKGROUND:Although the elderly represents a rapidly growing population among transplant recipients, age-specific aspects have not been considered sufficiently in clinical trials. Moreover, age-specific effects of immunosuppressive therapies remain poorly understood. METHODS:Here, we assessed the impact of rapamycin o...


    pub_type: 杂志文章


    authors: Quante M,Heinbokel T,Edtinger K,Minami K,Uehara H,Nian Y,Azuma H,Abdi R,Elkhal A,Tullius SG

    更新日期:2018-01-01 00:00:00

  • Contrasting in vivo effects on T helper cell functions induced by mitogenic (intact) versus nonmitogenic (F(ab')2) anti-CD3 monoclonal antibody.

    abstract::Anti-CD3 mAbs are potent inhibitors of T cell function; however, administration of mitogenic mAb can cause significant morbidity secondary to T cell activation and cytokine release. Nonmitogenic anti-CD3 mAb is immunosuppressive in mice without inducing detectable morbidity, and may thus be preferable for in vivo T ce...


    pub_type: 杂志文章


    authors: Sawchuk SS,Gates R,Hirsch R

    更新日期:1995-12-15 00:00:00

  • Selection of a suitable internal control gene for expression studies in pancreatic islet grafts.

    abstract::The use of real-time reverse transcription polymerase chain reaction to compare gene expression in different tissues and conditions requires normalization to an internal control that must be expressed at a constant level. Although a previous validation step is required to confirm that an internal control is appropriat...


    pub_type: 杂志文章


    authors: Rodriguez-Mulero S,Montanya E

    更新日期:2005-09-15 00:00:00

  • Effects of protein-calorie restriction on the immune response to skin allografts in the rat.

    abstract::The effect of protein depletion on immune responsiveness was examined using a skin allograft model. Protein depletion was induced in adult Fischer (F344) male rats by the ad libitum provision of a 5% protein diet. Total serum protein, total body weight, total body nitrogen, and total body lipid were all markedly decre...


    pub_type: 杂志文章


    authors: Austin EH,Brennan MF,Rosenberg SA

    更新日期:1980-09-01 00:00:00

  • HLA antibody screening: comparison of a solid phase enzyme-linked immunoassay with antiglobulin-augmented lymphocytotoxicity.

    abstract:BACKGROUND:IgG antibodies to HLA class I antigens can cause hyperacute rejection of renal allografts. Screening of sera from such transplant candidates is laborious, time-consuming, and expensive when performed by sensitive antihuman globulin-augmented lymphocytotoxicity (AHG-CDC). METHODS:Because 60-70% of our transp...


    pub_type: 临床试验,杂志文章


    authors: Moore SB,Ploeger NA,DeGoey SR

    更新日期:1997-12-15 00:00:00

  • Comparison of human islet isolation outcomes using a new mammalian tissue-free enzyme versus collagenase NB-1.

    abstract:BACKGROUND:After the discontinuation of the manufacturing Liberase HI because of a small potential for prion disease transmission, Roche Diagnostics (Indianapolis, IN) developed a new enzyme product (Liberase MTF [mammalian tissue free]), which is similar to Liberase HI with the exception that no mammalian tissue is us...


    pub_type: 杂志文章


    authors: O'Gorman D,Kin T,Imes S,Pawlick R,Senior P,Shapiro AM

    更新日期:2010-08-15 00:00:00

  • Knockdown of intraislet IKKβ by spherical nucleic acid conjugates prevents cytokine-induced injury and enhances graft survival.

    abstract:BACKGROUND:The efficiency of islet graft survival after intraportal implantation is compromised by host innate immune responses and the production of proinflammatory cytokines that cause acute cellular injury. This reaction activates intraislet nuclear factor-κB (NF-κB), causing production of gene products that have de...


    pub_type: 杂志文章


    authors: Rink JS,McMahon KM,Zhang X,Chen X,Mirkin CA,Thaxton CS,Kaufman DB

    更新日期:2013-11-27 00:00:00

  • Arterial ketone body ratio as a possible indicator for liver transplantation in fulminant hepatic failure.

    abstract::Arterial ketone body ratio (AKBR [acetoacetate/beta-hydroxybutyrate]) was measured in nineteen patients under medical supportive therapy for fulminant hepatic failure (FHF), in order to evaluate its predictive value relative to liver transplantation. Of the 19 patients 8 (42%) were salvaged and 11 (58%) died. Seven of...


    pub_type: 杂志文章


    authors: Saibara T,Onishi S,Sone J,Yamamoto N,Shimahara Y,Mori K,Ozawa K,Yamamoto Y

    更新日期:1991-04-01 00:00:00

  • Malignant disease in renal transplant patients.

    abstract::The incidence of malignant disease (renal cancer and skin cancer excluded) was analyzed in 934 renal transplant patients from one center, transplanted between 1965 and 1981, and followed through 1983. National Cancer Registry data were used for statistical comparison. Cancers of the lip, vulva, and anus and malignant ...


    pub_type: 杂志文章


    authors: Blohmé I,Brynger H

    更新日期:1985-01-01 00:00:00

  • Graft-versus-host-disease-associated thymic damage results in the appearance of T cell clones with anti-host reactivity.

    abstract:BACKGROUND:We studied whether T-cell clones, which appear in the periphery as a result of the failure of thymic negative selection during graft-versus-host disease (GVHD), have any in vivo anti-host reactivity and can cause GVHD in an adoptive transfer model. METHODS:We performed our studies in a murine model (B10.BR ...


    pub_type: 杂志文章


    authors: van den Brink MR,Moore E,Ferrara JL,Burakoff SJ

    更新日期:2000-02-15 00:00:00

  • Cultured mouse keratinocyte allografts prime for accelerated second set rejection and enhanced cytotoxic lymphocyte response.

    abstract::It has been reported that cultured keratinocyte (CK) allografts are not rejected in mice, unlike in other species. Several reports have suggested that mouse CK allografts are incapable of stimulating a primary alloresponse, including sensitization of recipients to alloantigens. In this study, we investigated the immun...


    pub_type: 杂志文章


    authors: Cairns BA,deSerres S,Matsui M,Frelinger JA,Meyer AA

    更新日期:1994-07-15 00:00:00

  • Immunosuppression in canine renal allografts using niridazole.

    abstract::The immunosuppressive activity of niridazole in unmatched kidney allografts in nephrectomized dogs was studied. The drug alone was not effective, but improved survival when used with azathioprine and prednisolone or azathioprine alone. However, niridazole was toxic in dogs in the doses used (25 or 50 mg/kg/day). ...


    pub_type: 杂志文章


    authors: Sokucu N,Caridis DT,Moran J

    更新日期:1980-04-01 00:00:00

  • Major histocompatibility complex class II expression is required for posttransplant immunological but not hemopoietic reconstitution in mice.

    abstract::We had previously shown in a canine model that the administration of anti-MHC class II monoclonal antibody (MAB) immediately after autologous marrow transplantation prevented hemopoietic reconstitution. Since MHC class II expression in mice differs from that in dogs we were interested in determining the effect of MHC ...


    pub_type: 杂志文章


    authors: Huss R,Beckham C,Storb R,Deeg HJ

    更新日期:1994-12-27 00:00:00

  • Comparison of pulsatile perfusion and cold storage for paired kidney allografts.

    abstract::Use of pulsatile perfusion to optimize outcomes in deceased donor kidney transplantation remains controversial. This study is a retrospective analysis of all cadaveric renal allografts procured locally by our center over a 3-year period. Kidney pairs were identified in which one kidney underwent pulsatile perfusion an...


    pub_type: 杂志文章


    authors: Shah AP,Milgrom DP,Mangus RS,Powelson JA,Goggins WC,Milgrom ML

    更新日期:2008-10-15 00:00:00

  • A simplified model for heterotopic rat heart transplantation.

    abstract::A technique for simplified heterotopic rat heart transplantation having only aorto-aortic anastomosis is presented. The heterotopic rt heart survives and functions well when one lung lobe is attached t the transplantation and functions as a reservoir. Iso- and allotransplants are compared by electrocardiogram (ECG) de...


    pub_type: 杂志文章


    authors: Lee S,Macedo AR,Curtis GP,Lee D,Orloff MJ

    更新日期:1982-04-01 00:00:00

  • Transcriptional inhibition of insulin by FK506 and possible involvement of FK506 binding protein-12 in pancreatic beta-cell.

    abstract::FK506 (tacrolimus) is a strong immunosuppressant: it has been approved as a drug for liver transplantation in Japan, the United States, and the United Kingdom. One of its main adverse effects is hyperglycemia. Thus, in this study, we investigated the mechanism and the reversibility of the hyperglycemia caused by FK506...


    pub_type: 杂志文章


    authors: Tamura K,Fujimura T,Tsutsumi T,Nakamura K,Ogawa T,Atumaru C,Hirano Y,Ohara K,Ohtsuka K,Shimomura K

    更新日期:1995-06-15 00:00:00

  • Temporal trends in lung transplant center volume and outcomes in the United States.

    abstract::Publicly available program-specific data from the scientific registry of transplant recipients were used to determine the association between adult lung transplant center volume and 1-year recipient mortality from 2000 to 2007. We found a significant inverse association between the center volume of adult lung transpla...


    pub_type: 杂志文章


    authors: Scarborough JE,Bennett KM,Davis RD,Lin SS,Tracy ET,Kuo PC,Pappas TN

    更新日期:2010-03-27 00:00:00

  • Oxygen free radical content and neutrophil infiltration are important determinants in mucosal injury after rat small bowel transplantation.

    abstract::Mucosal injury is an immediate event following revascularization of small intestinal grafts in the context of transplantation (SBTx). The generation of oxygen free radicals (OFR) and tissue infiltration by activated neutrophils are consequences of ischemia and reperfusion and known causative factors of tissue injury; ...


    pub_type: 杂志文章


    authors: Cicalese L,Caraceni P,Nalesnik MA,Borle AB,Schraut WH

    更新日期:1996-07-27 00:00:00

  • Postirradiation recovery of lymphoid cells in the rat.

    abstract::Whole-body irradiation has been extensively used to ablate immune responsiveness in rodent recipients in adoptive allograft assays. This study was undertaken to determine the relative radioresistance and the tempo of regeneration, following whole-body irradiation, of cells involved in the allograft response. Six disti...


    pub_type: 杂志文章


    authors: Farnsworth A,Wotherspoon JS,Dorsch SE

    更新日期:1988-09-01 00:00:00

  • Inhibitor against coagulation factor V after liver transplantation.

    abstract::A new case of anti-factor V inhibitor is described in a 46-year-old man, who received a liver transplantation for hepatocellular carcinoma, without exposure to bovine thrombin or fibrin glue during the operative course. The inhibition occurred on the 14th postoperative day, while the patient was being treated with oxa...


    pub_type: 杂志文章


    authors: Leroy-Matheron C,Mallat A,Duvoux C,Métreau JM,Cherqui D,Dhumeaux D,Gouault-Heilmann M

    更新日期:1999-10-15 00:00:00

  • Impact of early conversion from tacrolimus to sirolimus on chronic allograft changes in kidney recipients on rapid steroid withdrawal.

    abstract:BACKGROUND:Calcineurin-inhibitor therapy is a contributing factor to the origin of interstitial fibrosis and tubular atrophy (IFTA). METHODS:We conducted a prospective randomized trial of conversion of tacrolimus to sirolimus at 1-month posttransplant in kidney transplant recipients on rapid steroid withdrawal. We com...


    pub_type: 杂志文章,随机对照试验


    authors: Heilman RL,Cortese C,Geiger XJ,Younan K,Wadei HM,Mai ML,Reddy KS,Gonwa TA

    更新日期:2012-01-15 00:00:00

  • A prospective randomized trial comparing sequential ganciclovir-high dose acyclovir to high dose acyclovir for prevention of cytomegalovirus disease in adult liver transplant recipients.

    abstract::Cytomegalovirus disease is an important cause of morbidity following liver transplantation. To date there has not been an effective prophylaxis for CMV disease after liver transplantation. One hundred forty-three patients were randomized to receive either high dose oral acyclovir (800 mg 4 times a day) alone for 3 mon...


    pub_type: 临床试验,杂志文章,随机对照试验


    authors: Martin M,Mañez R,Linden P,Estores D,Torre-Cisneros J,Kusne S,Ondick L,Ptachcinski R,Irish W,Kisor D

    更新日期:1994-10-15 00:00:00