In vivo oxidized low-density lipoprotein (ox-LDL) aopp and tas after kidney transplantation: a prospective, randomized one year study comparing cyclosporine a and tacrolimus based regiments

Zadrazil, J; Horák, Pavel; Štrebl, Pavel; Krejčí, Karel; Kajabová, Markéta; Schneiderka, Petr; Zapletalová, Jana; Galandáková, Adéla; Vostalová, Jitka; Vaverková, H

doi:10.5507/bp.2012.008

Cited by 10 publications

(27 citation statements)

References 36 publications

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“…The remaining trials (one induction study 97 and 20 maintenance studies 75,81,85,91,[99][100][101][102]104,109,110,112,114,115,117,[119][120][121][122]127 ) did not report any information about blinding participants to treatment allocation.…”

Section: Treatment Allocation Masked From Participantsmentioning

confidence: 99%

“…Fifty-four trials 51,[72][73][74][76][77][78][79][81][82][83][84][85][87][88][89][91][92][93]95,96,[98][99][100][102][103][104][105][106][108][109][110][111][112][113][115][116][117][118][119][120]124,127,131,134,135,139,141,[143][144][145][153][154][155] did not report any information on allocation concealment, whereas 20 trials 71,…”

Section: Concealment Of Allocationmentioning

confidence: 99%

“…Fifty-seven trials (48 maintenance studies, 51,58,77,[80][81][82]84,86,94,99,100,102,[104][105][106][107][108][109][113][114][115][116][117][119][120][121][124][125][126][127]131,132,134,138,139,[141][142][143][144][145][146][147]149,150,152,154,156,157 eight induction studies 71,72,74,87,97,128,137 and one study …”

Section: Baseline Characteristicsmentioning

confidence: 99%

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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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Section: Treatment Allocation Masked From Participantsmentioning

confidence: 99%

Section: Concealment Of Allocationmentioning

confidence: 99%

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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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“…36 There are no significant changes in oxidized LDL at 12 months after than before kidney transplant. 37 There were no significant differences in oxidized LDL between patients treated with cyclosporine or tacrolimus. 37 The mechanism of toxicity of calcineurin inhibitors is not fully understood, but oxidative stress induced by these drugs may be important.…”

Section: Discussionmentioning

confidence: 95%

“…37 There were no significant differences in oxidized LDL between patients treated with cyclosporine or tacrolimus. 37 The mechanism of toxicity of calcineurin inhibitors is not fully understood, but oxidative stress induced by these drugs may be important. In kidney transplant recipients who have a stable graft, oxidative stress is present less than in hemodialysis patients but more than in the general population.…”

Section: Discussionmentioning

confidence: 95%

Untitled

Kahvecioğlu

Güllülü²,

Dirican³

2014

Exp Clin Transplant

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Objectives: Cardiovascular disease is a common cause of morbidity and mortality in patients with chronic kidney failure, before and after a kidney transplant. Oxidation of lipoproteins that contain apolipoprotein B may contribute to the initiation of atherosclerosis. Paraoxonase may prevent cardiovascular disease. We compared the effects of different calcineurin inhibitors on risk factors for cardiovascular disease in kidney transplant recipients. Materials and Methods: In 16 kidney transplant recipients, treatment included tacrolimus in 8 patients and cyclosporine in 8 patients. Hemoglobin, glucose, renal function, lipid parameters, high-sensitivity C-reactive protein, homocysteine, malondialdehyde, paraoxonase activity, and arylesterase activity were measured before transplant and at 1, 6, and 12 months after the transplant. Results: The levels of homocysteine and malondialdehyde did not change significantly in patients who received either tacrolimus or cyclosporine. The high-sensitivity C-reactive protein was decreased (tacrolimus group, 1 mo) and increased (cyclosporine group, 6 and 12 mo) after the kidney transplant. Paraoxonase activity was increased (tacrolimus group, 1 mo). Arylesterase activity was increased (tacrolimus group, 1, 6, and 12 mo; cyclosporine group, 1 and 6 mo). The percentage of change in arylesterase activity was higher at 12 months in the tacrolimus than in the cyclosporine group. Conclusions: Tacrolimus may be more effective than cyclosporine in improving risk factors for cardiovascular disease after kidney transplant.

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The essential role of annexin A1 mimetic peptide in the skin allograft survival

Teixeira

Mimura

Araújo

et al. 2013

J Tissue Eng Regen Med

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Immunosuppressive drugs have a critical role in inhibiting tissue damage and allograft rejection. Studies have demonstrated the anti-inflammatory effects of the annexin A1 (AnxA1) in the regulation of transmigration and apoptosis of leucocytes. In the present study, an experimental skin allograft model was used to evaluate a potential protective effect of AnxA1 in transplantation survival. Mice were used for the skin allograft model and pharmacological treatments were carried out using either the AnxA1 mimetic peptide Ac2-26, with or without cyclosporine A (CsA), starting 3 days before surgery until rejection. Graft survival, skin histopathology, leucocyte transmigration and expression of AnxA1 and AnxA5 post-transplantation were analysed. Pharmacological treatment with Ac2-26 increased skin allograft survival related with inhibition of neutrophil transmigration and induction of apoptosis, thereby reducing the tissue damage compared with control animals. Moreover, AnxA1 and AnxA5 expression increased after Ac2-26 treatment in neutrophils. Interestingly, the combination of Ac2-26 and cyclosporine A showed similar survival of transplants when compared with the cyclosporine A group, which could be attributed to a synergistic effect of both drugs. Investigations in vitro revealed that cyclosporine A inhibited extracellular-signal-regulated kinase (ERK) phosphorylation induced by Ac2-26 in neutrophils. Overall, the results suggest that AnxA1 has an essential role in augmenting the survival of skin allograft, mainly owing to inhibition of neutrophil transmigration and enhancement of apoptosis. This effect may lead to the development of new therapeutic approaches relevant to transplant rejection.

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In vivo oxidized low-density lipoprotein (ox-LDL) aopp and tas after kidney transplantation: a prospective, randomized one year study comparing cyclosporine a and tacrolimus based regiments

Cited by 10 publications

References 36 publications

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

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

Untitled

The essential role of annexin A1 mimetic peptide in the skin allograft survival

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