Once-Daily Extended-Release Versus Twice-Daily Standard-Release Tacrolimus in Kidney Transplant Recipients: A Systematic Review

BACKGROUNDA simplified dosing regimen may improve drug compliance in kidney transplant recipients and long-term graft outcomes. We aimed to identify, appraise, and synthesize the current evidence comparing the relative safety and efficacy of the recently introduced daily versus standard twice-daily...

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Veröffentlicht in:Transplantation 2013-05, Vol.95 (9), p.1120-1128
Hauptverfasser: Ho, Elaine T.L, Wong, Germaine, Craig, Jonathan C, Chapman, Jeremy R
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container_end_page 1128
container_issue 9
container_start_page 1120
container_title Transplantation
container_volume 95
creator Ho, Elaine T.L
Wong, Germaine
Craig, Jonathan C
Chapman, Jeremy R
description BACKGROUNDA simplified dosing regimen may improve drug compliance in kidney transplant recipients and long-term graft outcomes. We aimed to identify, appraise, and synthesize the current evidence comparing the relative safety and efficacy of the recently introduced daily versus standard twice-daily tacrolimus administration. METHODSWe systematically reviewed all randomized controlled trials and observational studies that compared the outcomes of daily versus twice-daily tacrolimus formulation in kidney transplant recipients. Medline (from 1948 to July week 4 2011), Embase (1980 to 2011 week 31), the Cochrane Library (1991 to June 2011), and conference proceedings were searched without language restriction. RESULTSSix randomized controlled trials (n=2499) and 15 observational studies (n=2886) were included in the review. There were no significant differences in biopsy-proven acute rejection (two trials, n=1093; risk ratio [RR; confidence interval (CI)], 1.24 [0.93–1.65]; P=0.15; I=0%), patient survival (three trials, n=1156; RR [CI], 0.99 [0.97–1.02]; P=0.55; I=32%), and graft survival (three trials, n=1156; RR [CI], 0.99 [0.97–1.02]; P=0.67; I=0%) between the two formulations at 12 months. Similar results for acute rejection (five studies, n=391; RR [CI], 0.99 [0.93–1.06]; P=0.84; I=0%) and overall patient survival (two studies, n=218; RR [CI], 1.02 [0.94–1.10]; P=0.62; I=0%) were observed in observational studies. CONCLUSIONSOnce-daily tacrolimus appears to be as effective as twice-daily tacrolimus up to 12 months after kidney transplantation.
doi_str_mv 10.1097/TP.0b013e318284c15b
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We aimed to identify, appraise, and synthesize the current evidence comparing the relative safety and efficacy of the recently introduced daily versus standard twice-daily tacrolimus administration. METHODSWe systematically reviewed all randomized controlled trials and observational studies that compared the outcomes of daily versus twice-daily tacrolimus formulation in kidney transplant recipients. Medline (from 1948 to July week 4 2011), Embase (1980 to 2011 week 31), the Cochrane Library (1991 to June 2011), and conference proceedings were searched without language restriction. RESULTSSix randomized controlled trials (n=2499) and 15 observational studies (n=2886) were included in the review. There were no significant differences in biopsy-proven acute rejection (two trials, n=1093; risk ratio [RR; confidence interval (CI)], 1.24 [0.93–1.65]; P=0.15; I=0%), patient survival (three trials, n=1156; RR [CI], 0.99 [0.97–1.02]; P=0.55; I=32%), and graft survival (three trials, n=1156; RR [CI], 0.99 [0.97–1.02]; P=0.67; I=0%) between the two formulations at 12 months. Similar results for acute rejection (five studies, n=391; RR [CI], 0.99 [0.93–1.06]; P=0.84; I=0%) and overall patient survival (two studies, n=218; RR [CI], 1.02 [0.94–1.10]; P=0.62; I=0%) were observed in observational studies. CONCLUSIONSOnce-daily tacrolimus appears to be as effective as twice-daily tacrolimus up to 12 months after kidney transplantation.</description><identifier>ISSN: 0041-1337</identifier><identifier>EISSN: 1534-6080</identifier><identifier>DOI: 10.1097/TP.0b013e318284c15b</identifier><identifier>PMID: 23542469</identifier><language>eng</language><publisher>United States: Lippincott Williams &amp; Wilkins, Inc</publisher><subject>Bacterial Infections - epidemiology ; Drug Administration Schedule ; Graft Rejection ; Graft Survival ; Humans ; Immunosuppressive Agents - administration &amp; dosage ; Kidney Transplantation - mortality ; Randomized Controlled Trials as Topic ; Tacrolimus - administration &amp; dosage ; Tacrolimus - pharmacokinetics</subject><ispartof>Transplantation, 2013-05, Vol.95 (9), p.1120-1128</ispartof><rights>2013 Lippincott Williams &amp; Wilkins, Inc.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c336b-1349684f24555bd6cdcd6782b8fa4005d454113517d9e9bc0ea50810ddb3f9f63</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/23542469$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Ho, Elaine T.L</creatorcontrib><creatorcontrib>Wong, Germaine</creatorcontrib><creatorcontrib>Craig, Jonathan C</creatorcontrib><creatorcontrib>Chapman, Jeremy R</creatorcontrib><title>Once-Daily Extended-Release Versus Twice-Daily Standard-Release Tacrolimus in Kidney Transplant Recipients: A Systematic Review</title><title>Transplantation</title><addtitle>Transplantation</addtitle><description>BACKGROUNDA simplified dosing regimen may improve drug compliance in kidney transplant recipients and long-term graft outcomes. We aimed to identify, appraise, and synthesize the current evidence comparing the relative safety and efficacy of the recently introduced daily versus standard twice-daily tacrolimus administration. METHODSWe systematically reviewed all randomized controlled trials and observational studies that compared the outcomes of daily versus twice-daily tacrolimus formulation in kidney transplant recipients. Medline (from 1948 to July week 4 2011), Embase (1980 to 2011 week 31), the Cochrane Library (1991 to June 2011), and conference proceedings were searched without language restriction. RESULTSSix randomized controlled trials (n=2499) and 15 observational studies (n=2886) were included in the review. There were no significant differences in biopsy-proven acute rejection (two trials, n=1093; risk ratio [RR; confidence interval (CI)], 1.24 [0.93–1.65]; P=0.15; I=0%), patient survival (three trials, n=1156; RR [CI], 0.99 [0.97–1.02]; P=0.55; I=32%), and graft survival (three trials, n=1156; RR [CI], 0.99 [0.97–1.02]; P=0.67; I=0%) between the two formulations at 12 months. Similar results for acute rejection (five studies, n=391; RR [CI], 0.99 [0.93–1.06]; P=0.84; I=0%) and overall patient survival (two studies, n=218; RR [CI], 1.02 [0.94–1.10]; P=0.62; I=0%) were observed in observational studies. 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We aimed to identify, appraise, and synthesize the current evidence comparing the relative safety and efficacy of the recently introduced daily versus standard twice-daily tacrolimus administration. METHODSWe systematically reviewed all randomized controlled trials and observational studies that compared the outcomes of daily versus twice-daily tacrolimus formulation in kidney transplant recipients. Medline (from 1948 to July week 4 2011), Embase (1980 to 2011 week 31), the Cochrane Library (1991 to June 2011), and conference proceedings were searched without language restriction. RESULTSSix randomized controlled trials (n=2499) and 15 observational studies (n=2886) were included in the review. 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source MEDLINE; Journals@Ovid Complete
subjects Bacterial Infections - epidemiology
Drug Administration Schedule
Graft Rejection
Graft Survival
Humans
Immunosuppressive Agents - administration & dosage
Kidney Transplantation - mortality
Randomized Controlled Trials as Topic
Tacrolimus - administration & dosage
Tacrolimus - pharmacokinetics
title Once-Daily Extended-Release Versus Twice-Daily Standard-Release Tacrolimus in Kidney Transplant Recipients: A Systematic Review
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