A prospective randomized trial comparing the efficacy of tacrolimus versus cyclosporine in black recipients of primary cadaveric renal transplants

Raofi, Vandad; Holman, Dawn M.; Coady, Noreen T; Vázquez, Eva Gimeno; Dunn, Ty B.; Bartholomew, Amelia; Pollak, Raymond; Benedetti, Enrico

doi:10.1016/s0002-9610(99)00042-2

Cited by 26 publications

(24 citation statements)

References 15 publications

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“…However, 10 trials 93,102,104,109,115,117,121,131,135,149 had zero events in all arms and were excluded from the NMA, resulting in 42 trials 51,59,76,78,80,83,84,86,[88][89][90]92,100,103,107,108,[110][111][112]116,118,120,122,[125][126][127]129,130,133,134,136,138,[142][143][144][145]147,[150][151][152]155,210 contributing to the NMA (including four three-arm trials 51,…”

Section: Mortalitymentioning

confidence: 99%

“…NIHR Journals Library www.journalslibrary.nihr.ac.uk Thirteen treatments and 42 studies 51,59,76,[81][82][83]86,[88][89][90]92,93,100,103,107,110,112,[115][116][117][118]120,121,[125][126][127]129,131,[133][134][135][136]142,144,145,147,149,150,152,210 (including three three-arm studies 51,126,152 and one four-arm study 122 ) contribute to this NMA ( Figure 62). …”

Section: Assessment Of Clinical Effectivenessmentioning

confidence: 99%

“…Thirty-nine studies 60,80,82,83,86,88,90,92,100,104,106,107,[110][111][112]116,117,120,121,126,127,131,133,134,136,138,141,144,147,149,152,177,194,195,204,206,207,210,427 (of the 76 maintenance studies) reported some AEs at 1-year follow-up. Twenty-seven studies reported NODAT, 51,58,59,80,83,88,90,92,100,107,110,112,116,117,120,121,…”

Section: Maintenance Regimensmentioning

confidence: 99%

“…l The meta-analysis comparing TAC and CSA regimens (including eight studies 51,80,83,88,90,100,121,210 ) suggested more cases of new-onset diabetes after transplant/transplantation (NODAT) in TAC regimens than in CSA regimens. l The meta-analyses comparing BEL with CSA regimens (including three studies 59,125,142 ) suggested more cases of NODAT in CSA regimens than in BEL regimens.…”

mentioning

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: Mortalitymentioning

confidence: 99%

Section: Assessment Of Clinical Effectivenessmentioning

confidence: 99%

Section: Maintenance Regimensmentioning

confidence: 99%

mentioning

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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“…Tacrolimus also causes posttransplant hypertension, although the data suggest that cyclosporine produces greater renal vasoconstriction and resultant systemic hypertension at an earlier onset than tacrolimus [94,95]. Furthermore, one study found higher serum creatinine and cholesterol levels among African-Americans taking cyclosporine versus tacrolimus 1 year after cadaveric kidney transplantation [96]. Concurrent use of corticosteroids also augments the risk of posttransplant hypertension.…”

Section: Causes Of Posttransplant Hypertensionmentioning

confidence: 99%

Hypertension in special populations

et al. 2002

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Tacrolimus versus cyclosporin as primary immunosuppression for kidney transplant recipients

Webster

Taylor

Chapman

et al. 2005

Cochrane Database of Systematic Reviews

201

170

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Tacrolimus is superior to cyclosporin in improving graft survival and preventing acute rejection after kidney transplantation, but increases post-transplant diabetes, neurological and gastrointestinal side effects. Treating 100 recipients with tacrolimus instead of cyclosporin would avoid 12 suffering acute rejection, two losing their graft but cause an extra five to become insulin-requiring diabetics.

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A prospective randomized trial comparing the efficacy of tacrolimus versus cyclosporine in black recipients of primary cadaveric renal transplants

Cited by 26 publications

References 15 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

Hypertension in special populations

Tacrolimus versus cyclosporin as primary immunosuppression for kidney transplant recipients

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