Consistent absorption of cyclosporine from a microemulsion formulation assessed in stable renal transplant recipients over a one-year study period.

Abstract:

:To evaluate the pharmacokinetic properties of the new microemulsion formulation of cyclosporine (Sandimmun Neoral), a double-blind, prospective study in stable renal transplant recipients was performed. The patients were randomized on a 4:1 basis either to receive Sandimmun Neoral (n = 45) or continue on regular Sandimmun (n = 12). Before randomization, a steady-state pharmacokinetic profile study was performed in all patients while they were still on regular Sandimmun. Pharmacokinetic assessments were then performed after 8 and 12 weeks and after 1 year. A milligram-to-milligram dose conversion was shown to be adequate to maintain the patients within a predefined target therapeutic window. Changes in pharmacokinetic parameters after conversion to Sandimmun Neoral were consistent with an increased rate and extent of cyclosporine absorption from the Neoral formulation. This was reflected by a shorter time to reach peak concentration and also by a mean increase in peak concentration by 67%, and an overall mean increase in drug exposure (area under the curve) by 34%. These findings were also confirmed 1 year after conversion. Furthermore, significantly reduced intraindividual variability in pharmacokinetic parameters was found, as well as improvements in the correlation between trough concentrations and area under the curve after conversion to Sandimmun Neoral. In conclusion, our results indicate an improved and consistent absorption of cyclosporine from the Neoral formulation, which should make clinical management easier and safer.

journal_name

Transplantation

journal_title

Transplantation

authors

Wahlberg J,Wilczek HE,Fauchald P,Nordal KP,Heaf JG,Olgaard K,Hansen JM,Lokkegaard H,Mueller EA,Kovarik JM

doi

10.1097/00007890-199510150-00005

subject

Has Abstract

pub_date

1995-10-15 00:00:00

pages

648-52

issue

7

eissn

0041-1337

issn

1534-6080

journal_volume

60

pub_type

临床试验,杂志文章,多中心研究,随机对照试验
  • Quality of life of liver transplant recipients. A pilot study.

    abstract::In a cross-sectional survey of the quality of life of 45 liver transplant recipients, physical and psychological status, physical complaints, capability to participate in daily life, social support, and global quality of life were assessed. The average time of follow-up was 9 months after transplantation. Nine patient...

    journal_title:Transplantation

    pub_type: 杂志文章

    doi:10.1097/00007890-199309000-00013

    authors: Leyendecker B,Bartholomew U,Neuhaus R,Hörhold M,Blumhardt G,Neuhaus P,Klapp BF

    更新日期:1993-09-01 00:00:00

  • Diltiazem in renal allograft recipients receiving cyclosporine.

    abstract::Of 113 cyclosporine-treated primary renal allograft recipients, 60 were randomized to receive standard therapy without diltiazem (ND) and 53 received standard therapy plus diltiazem (D). There was no difference in CsA blood levels between ND and D at all intervals between 3 and 24 months follow-up, yet the D group req...

    journal_title:Transplantation

    pub_type: 临床试验,杂志文章,随机对照试验

    doi:10.1097/00007890-199302000-00014

    authors: Chrysostomou A,Walker RG,Russ GR,d'Apice AJ,Kincaid-Smith P,Mathew TH

    更新日期:1993-02-01 00:00:00

  • Transplantation of pediatric en bloc cadaver kidneys into adult recipients.

    abstract:BACKGROUND:To maximize the renal donor pool, cadaveric pediatric en bloc kidneys have been transplanted as a dual unit by some transplant centers. We compared the short- and long-term outcomes of adult recipients of cadaveric pediatric en bloc renal transplants versus those of matched recipients of cadaveric adult kidn...

    journal_title:Transplantation

    pub_type: 杂志文章

    doi:10.1097/00007890-199812270-00020

    authors: Hobart MG,Modlin CS,Kapoor A,Boparai N,Mastroianni B,Papajcik D,Flechner SM,Goldfarb DA,Fischer R,O'Malley KJ,Novick AC

    更新日期:1998-12-27 00:00:00

  • CD4 Th2 cells do not functionally suppress CTL generation in neonatal tolerant mice.

    abstract::Injecting semiallogeneic CAF1 spleen into BALB/c newborn mice renders mice tolerant, and the majority of mice show prolonged survival of tolerogen-bearing A/J skin grafts. Moreover, graft survival is associated with enhanced Th2 cytokine responses and graft rejection with Th1 cytokine responses. To further delineate t...

    journal_title:Transplantation

    pub_type: 杂志文章

    doi:

    authors: Gao Q,Chen N,Field EH

    更新日期:1995-12-15 00:00:00

  • Depletion of hepatitis C virus from procured kidneys using pulsatile perfusion preservation.

    abstract::The safety of the use of kidneys procured from a hepatitis C virus (HCV)-positive cadaver donors in transplantation has recently been the subject of controversy. One factor that is important in determining the transmission of the virus and/or viral liver disease is the total viral inoculum to which the renal allograft...

    journal_title:Transplantation

    pub_type: 杂志文章

    doi:10.1097/00007890-199403270-00011

    authors: Zucker K,Cirocco R,Roth D,Olson L,Burke GW,Nery J,Esquenazi V,Miller J

    更新日期:1994-03-27 00:00:00

  • The poly(adenosine diphosphate-ribose) polymerase inhibitor PJ34 reduces pulmonary ischemia-reperfusion injury in rats.

    abstract:BACKGROUND:Ischemia-reperfusion (I/R) injury after lung transplantation causes alveolar damage, lung edema, and acute rejection. Poly(adenosine diphosphate-ribose) polymerase (PARP) is a single-stranded DNA repair enzyme that induces apoptosis and necrosis after DNA damage caused by reactive oxygen species. We evaluate...

    journal_title:Transplantation

    pub_type: 杂志文章

    doi:10.1097/TP.0000000000000305

    authors: Hatachi G,Tsuchiya T,Miyazaki T,Matsumoto K,Yamasaki N,Okita N,Nanashima A,Higami Y,Nagayasu T

    更新日期:2014-09-27 00:00:00

  • Intragraft cytokine profile during human liver allograft rejection.

    abstract::Forty-three human liver allograft biopsies and normal liver were directly analyzed for inflammatory and immunoregulatory cytokine gene expression by polymerase chain reaction (PCR). IL-5 gene expression was predominantly present in biopsies from liver allografts with histopathological evidence of acute rejection. IL-2...

    journal_title:Transplantation

    pub_type: 杂志文章

    doi:10.1097/00007890-199202010-00035

    authors: Martinez OM,Krams SM,Sterneck M,Villanueva JC,Falco DA,Ferrell LD,Lake J,Roberts JP,Ascher NL

    更新日期:1992-02-01 00:00:00

  • Immune response, accommodation, and tolerance to transplantation carbohydrate antigens.

    abstract::The carbohydrate antigens, blood groups A and B, and the alpha-gal epitope (Galalpha1-3Gal) are major risk factors in transplantation. Transplantation across ABO barriers may result in rejection by elicited anti-blood group antibodies, accommodation where elicited anti-blood group antibodies do not reject the graft, o...

    journal_title:Transplantation

    pub_type: 杂志文章,评审

    doi:10.1097/01.tp.0000142673.32394.95

    authors: Galili U

    更新日期:2004-10-27 00:00:00

  • The impact of hypoalbuminemia in kidney-pancreas transplant recipients.

    abstract:BACKGROUND:Hypoalbuminemia is associated with poorer outcomes in renal transplantation. Diabetes can compound hypoalbuminemia's detrimental effects. Kidney-pancreas transplantation alters the diabetic milieu; yet, some patients continue to be hypoalbuminemic. METHODS:We retrospectively analyzed 232 patients who underw...

    journal_title:Transplantation

    pub_type: 杂志文章

    doi:10.1097/00007890-199907150-00014

    authors: Becker BN,Becker YT,Heisey DM,Leverson GE,Collins BH,Odorico JS,D'Alessandro AM,Knechtle SJ,Pirsch JD,Sollinger HW

    更新日期:1999-07-15 00:00:00

  • A prospective randomized multicenter study of tacrolimus in combination with sirolimus in renal-transplant recipients.

    abstract:BACKGROUND:Recently, sirolimus (SRL) was introduced as an immunosuppressant in solid-organ transplantation. This study evaluated combinations of SRL and tacrolimus (Tac). METHODS:This 6-month study investigated the safety and efficacy of Tac and steroids in combination with three different doses of SRL in renal-transp...

    journal_title:Transplantation

    pub_type: 临床试验,杂志文章,多中心研究,随机对照试验

    doi:10.1097/01.TP.0000071301.86299.75

    authors: van Hooff JP,Squifflet JP,Wlodarczyk Z,Vanrenterghem Y,Paczek L

    更新日期:2003-06-27 00:00:00

  • The clinical utility of whole blood versus plasma cytomegalovirus viral load assays for monitoring therapeutic response.

    abstract:BACKGROUND:In patients with cytomegalovirus (CMV) disease, regular monitoring of viral loads and treatment until negative are recommended. However, with more sensitive polymerase chain reaction (PCR) assays and cellular peripheral sample types, detection of low-level viremia is achievable. We compared a whole blood rea...

    journal_title:Transplantation

    pub_type: 杂志文章,多中心研究,随机对照试验

    doi:10.1097/TP.0b013e3181ff8719

    authors: Lisboa LF,Asberg A,Kumar D,Pang X,Hartmann A,Preiksaitis JK,Pescovitz MD,Rollag H,Jardine AG,Humar A

    更新日期:2011-01-27 00:00:00

  • Animal models of chronic allograft injury: contributions and limitations to understanding the mechanism of long-term graft dysfunction.

    abstract::Advances in immunosuppression have reduced the incidence of acute graft loss after transplantation, but long-term allograft survival is still hindered by the development of chronic allograft injury, a multifactorial process that involves both immunologic and nonimmunologic components. Because these components become d...

    journal_title:Transplantation

    pub_type: 社论,评审

    doi:10.1097/TP.0b013e3181efcfbc

    authors: Bedi DS,Riella LV,Tullius SG,Chandraker A

    更新日期:2010-11-15 00:00:00

  • A computerized system for the selection of organ transplant recipients.

    abstract::The Southeastern Regional Organ Procurement Program has developed a computerized system for the selection of organ transplant recipients. This system has proven to be a useful method for the rapid selection of histocompatible recipients for organ transplants from a large pool of potential recipients in a wide geograp...

    journal_title:Transplantation

    pub_type: 杂志文章

    doi:10.1097/00007890-197501000-00005

    authors: Stulting RD,Ward FE

    更新日期:1975-01-01 00:00:00

  • Effects of tacrolimus on hyperlipidemia after successful renal transplantation: a Southeastern Organ Procurement Foundation multicenter clinical study.

    abstract:BACKGROUND:Tacrolimus has been shown to have a less adverse effect on the lipid profiles of transplant patients when the drug is started as induction therapy. In order to determine the effect tacrolimus has on lipid profiles in stable cyclosporine-treated renal transplant patients with established hyperlipidemia, a ran...

    journal_title:Transplantation

    pub_type: 临床试验,杂志文章,多中心研究,随机对照试验

    doi:10.1097/00007890-199801150-00017

    authors: McCune TR,Thacker LR II,Peters TG,Mulloy L,Rohr MS,Adams PA,Yium J,Light JA,Pruett T,Gaber AO,Selman SH,Jonsson J,Hayes JM,Wright FH Jr,Armata T,Blanton J,Burdick JF

    更新日期:1998-01-15 00:00:00

  • Clinical presentation of hepatic artery thrombosis after liver transplantation in the cyclosporine era.

    abstract::Hepatic artery thrombosis is a dreadful complication of orthotopic liver transplantation. It should be suspected in cases of fulminant liver failure, delayed bile leak, or intermittent sepsis of unknown cause after liver transplantation. Accurate diagnosis is assisted by ultrasound and computerized tomography scans, b...

    journal_title:Transplantation

    pub_type: 杂志文章

    doi:10.1097/00007890-198512000-00019

    authors: Tzakis AG,Gordon RD,Shaw BW Jr,Iwatsuki S,Starzl TE

    更新日期:1985-12-01 00:00:00

  • Pharmacokinetic Study of Conversion Between 2 Formulations of Once-daily Extended-release Tacrolimus in Stable Lung Transplant Patients.

    abstract:BACKGROUND:The aim of this study was to compare the pharmacokinetic profile, tolerability, and safety of a novel once-daily extended-release formulation of tacrolimus (LCPT) with that of once-daily prolonged-release tacrolimus (ODT) in stable adult lung transplant (LT) recipients. METHODS:Phase II, open-label, single-...

    journal_title:Transplantation

    pub_type: 杂志文章

    doi:10.1097/TP.0000000000002348

    authors: Sintes H,Sáez-Giménez B,Berastegui C,López-Meseguer M,Monforte V,Bravo C,Vima J,Gómez-Ollés S,Roman A

    更新日期:2018-10-01 00:00:00

  • The association of kidney graft outcome with pretransplant serum IgG-anti-F(ab')2 gamma activity.

    abstract::Pretransplant sera of 474 kidney graft recipients were tested for IgG-anti-F(ab')2 gamma activity. The patients had significantly higher IgG-anti-F(ab')2 gamma activity than healthy controls (P = 0.0004). Serum lymphocytotoxic antibodies were correlated with IgG-anti-F(ab')2 gamma (P = 0.004), whereas CMV infection an...

    journal_title:Transplantation

    pub_type: 杂志文章

    doi:10.1097/00007890-199210000-00012

    authors: Süsal C,Groth J,Oberg HH,Terness P,May G,Opelz G

    更新日期:1992-10-01 00:00:00

  • Tuberculosis in lung transplant recipients.

    abstract:BACKGROUND:Post-lung transplant infection is one of the leading causes of morbidity and mortality. The cause and incidence are similar in many series; however, infections such as Mycobacterium tuberculosis are influenced by the epidemiologic situation. The authors present a prospective and observational study to define...

    journal_title:Transplantation

    pub_type: 杂志文章

    doi:10.1097/01.tp.0000147784.53188.dc

    authors: Bravo C,Roldán J,Roman A,Degracia J,Majo J,Guerra J,Monforte V,Vidal R,Morell F

    更新日期:2005-01-15 00:00:00

  • Antihypertensive drug treatment in chronic renal allograft rejection in the rat. Effect on structure and function.

    abstract::To gain insight into the contribution of immunologic and hemodynamic factors in the progressive demise of structure and function in chronic renal allograft dysfunction, we studied the histological changes, the immunostainable glomerular anionic sites, and glomerular capillary hydrostatic pressures of rat renal allogra...

    journal_title:Transplantation

    pub_type: 杂志文章

    doi:10.1097/00007890-199612150-00018

    authors: Benediktsson H,Chea R,Davidoff A,Paul LC

    更新日期:1996-12-15 00:00:00

  • The specificity of nephritogenic antibodies. IV. Binding of monoclonal antithymocyte antibodies to rat kidney.

    abstract::Polyclonal rabbit antirat thymocyte serum (ATS) has been shown to form in situ glomerular immune aggregates following perfusion into normal rat kidney ex vivo. This may be due to the presence of T-cell-like epitopes in the rat kidney, or it may be a result of contaminating anti-connective-tissue antibodies in ATS. To ...

    journal_title:Transplantation

    pub_type: 杂志文章

    doi:10.1097/00007890-198606000-00015

    authors: Bagchus WM,Donga J,Rozing J,Hoedemaeker PJ,Bakker WW

    更新日期:1986-06-01 00:00:00

  • Increased levels of GALbeta1-4GLCNACalpha2-6 sialyltransferase pretransplant predict delayed graft function in kidney transplant recipients.

    abstract:BACKGROUND:Galbeta1-4GlcNAcalpha2-6 sialyltransferase (ST6GalI) is an acute phase reactant whose release from cells can be induced by proinflammatory cytokines. Because patients with chronic renal failure have high circulating levels of proinflammatory cytokines, we hypothesized that patients on the renal transplant wa...

    journal_title:Transplantation

    pub_type: 杂志文章

    doi:10.1097/00007890-200003150-00022

    authors: Thorne-Tjomsland G,Hosfield T,Jamieson JC,Liu B,Nickerson P,Gough JC,Rush DN,Jeffery JR,McKenna RM

    更新日期:2000-03-15 00:00:00

  • Living donor liver transplantation and tolerance: a potential strategy in cholangiocarcinoma.

    abstract:BACKGROUND:Donor-specific immune tolerance has been reported in isolated cases of kidney transplantation associated with bone marrow transplantation. The following is a description of a living donor liver transplantation for a hilar cholangiocarcinoma in a previous recipient of an allogeneic bone marrow transplant. ME...

    journal_title:Transplantation

    pub_type: 杂志文章

    doi:10.1097/01.TP.0000083981.82522.13

    authors: Kadry Z,Mullhaupt B,Renner EL,Bauerfeind P,Schanz U,Pestalozzi BC,Studer G,Zinkernagel R,Clavien PA

    更新日期:2003-09-27 00:00:00

  • The prevalence, course, and characteristics of chronic anemia after heart and lung transplantation.

    abstract::A retrospective study of the 99 surviving heart and lung transplant (HLT) recipients at one center showed that 31% had significant anemia (hemoglobin less than 100g/L) six months after transplantation. Chronic anemia persisted in 18% of HLT recipients two years posttransplantation. A similar study of 100 heart transpl...

    journal_title:Transplantation

    pub_type: 杂志文章

    doi:10.1097/00007890-199206000-00016

    authors: Hunt BJ,Amin S,Halil O,Yacoub M

    更新日期:1992-06-01 00:00:00

  • N-acetylcysteine ameliorates reperfusion injury after warm hepatic ischemia.

    abstract::Glutathione is important in cellular defense against oxidative stress. We postulated that administration of N-acetylcysteine (NAC), a glutathione precursor, might help maintain or replenish hepatic glutathione stores, thereby reducing reperfusion injury in liver grafts after warm ischemia. Eighteen pigs were subjected...

    journal_title:Transplantation

    pub_type: 杂志文章

    doi:10.1097/00007890-199501150-00002

    authors: Fukuzawa K,Emre S,Senyuz O,Acarli K,Schwartz ME,Miller CM

    更新日期:1995-01-15 00:00:00

  • Family Over Rules? An Ethical Analysis of Allowing Families to Overrule Donation Intentions.

    abstract::Millions of people want to donate their organs after they die for transplantation, and many of them have registered their wish to do so or told their family and friends about their decision. For most of them, however, this wish is unlikely to be fulfilled, as only a small number of deaths (1% in the United Kingdom) oc...

    journal_title:Transplantation

    pub_type: 杂志文章,评审

    doi:10.1097/TP.0000000000001536

    authors: Shaw D,Georgieva D,Haase B,Gardiner D,Lewis P,Jansen N,Wind T,Samuel U,McDonald M,Ploeg R,ELPAT Working Group on Deceased Donation.

    更新日期:2017-03-01 00:00:00

  • Pattern of liver, kidney, heart, and intestine allograft rejection in different mouse strain combinations.

    abstract::With advances in microsurgery and molecular biology, the mouse model for organ transplantation has become increasingly popular. However, knowledge about these models is limited, as only a small number of centers have experience with murine models. In this study, we compared the rejection pattern after liver, kidney, h...

    journal_title:Transplantation

    pub_type: 杂志文章

    doi:10.1097/00007890-199611150-00016

    authors: Zhang Z,Zhu L,Quan D,Garcia B,Ozcay N,Duff J,Stiller C,Lazarovits A,Grant D,Zhong R

    更新日期:1996-11-15 00:00:00

  • Pulmonary bronchoalveolar cell and protein kinetics in dogs given total-body irradiation, autologous marrow grafts, and methotrexate.

    abstract::Patients receiving allogeneic marrow transplantation for hematologic malignancies commonly are conditioned with total body irradiation (TBI) and given methotrexate (MTX) in an attempt to prevent graft-versus-host disease. To study the effects of TBI with or without MTX on bronchoalveolar cells and proteins, we perform...

    journal_title:Transplantation

    pub_type: 杂志文章

    doi:10.1097/00007890-198404000-00003

    authors: Springmeyer SC,Kopecky KJ,Deeg HJ,Whitehead J,Altman LC,Storb R

    更新日期:1984-04-01 00:00:00

  • Prevalence and correlates of self-reported pretransplant nonadherence with medication in heart, liver, and lung transplant candidates.

    abstract:BACKGROUND:Evidence on prevalence and correlates of pretransplant medication nonadherence (MNA) is limited. The present study explored self-reported prevalence and correlates of MNA before heart, liver, and lung transplantation. METHODS:This cross-sectional descriptive study included 174 patients: 69 lung, 33 heart, a...

    journal_title:Transplantation

    pub_type: 杂志文章

    doi:10.1097/01.tp.0000158430.06507.87

    authors: Dobbels F,Vanhaecke J,Desmyttere A,Dupont L,Nevens F,De Geest S

    更新日期:2005-06-15 00:00:00

  • Interpreting tacrolimus concentrations during pregnancy and postpartum.

    abstract::Pregnancy after solid organ transplantation, although considered high risk for maternal, fetal, and neonatal complications, has been quite successful. Tacrolimus pharmacokinetic changes during pregnancy make interpretation of whole blood trough concentrations particularly challenging. There are multiple factors that c...

    journal_title:Transplantation

    pub_type: 杂志文章,评审

    doi:10.1097/TP.0b013e318278d367

    authors: Hebert MF,Zheng S,Hays K,Shen DD,Davis CL,Umans JG,Miodovnik M,Thummel KE,Easterling TR

    更新日期:2013-04-15 00:00:00

  • False-negative results in anti-HLA antibody detection by Sangstat ELISA: complement dependent cytotoxicity is not yet obsolete.

    abstract::Although ELISA on purified HLA molecules for detecting anti-HLA antibody (P-S ELISA) does detect some antibodies previously missed by the conventional complement dependent cytotoxicity method (C Cytotox), HLA ELISA should not fail to detect antibodies already detected by the conventional reference method to be able to...

    journal_title:Transplantation

    pub_type: 杂志文章

    doi:10.1097/00007890-199611270-00031

    authors: Pierquin A,Masson D,Toupance O,Tabary T,Bougy F,Bensa JC,Chanard J,Cohen JH

    更新日期:1996-11-27 00:00:00