start-ver=1.4 cd-journal=joma no-vol=75 cd-vols= no-issue=6 article-no= start-page=830 end-page=846 dt-received= dt-revised= dt-accepted= dt-pub-year=2020 dt-pub=202006 dt-online= en-article= kn-article= en-subject= kn-subject= en-title= kn-title=Icodextrin Versus Glucose Solutions for the Once-Daily Long Dwell in Peritoneal Dialysis: An Enriched Systematic Review and Meta-analysis of Randomized Controlled Trials en-subtitle= kn-subtitle= en-abstract= kn-abstract=Rationale & Objective
The efficacy and safety of icodextrin versus glucose-only peritoneal dialysis (PD) regimens is unclear. The aim of this study was to compare once-daily long-dwell icodextrin versus glucose among patients with kidney failure undergoing PD.
Study Design
Systematic review of randomized controlled trials (RCTs), enriched with unpublished data from investigator-initiated and industry-sponsored studies.
Setting & Study Populations
Individuals with kidney failure receiving regular PD treatment enrolled in clinical trials of dialysate composition.
Selection Criteria for Studies
Medline, Embase, CENTRAL, Ichushi Web, 10 Chinese databases, clinical trials registries, conference proceedings, and citation lists from inception to November 2018. Further data were obtained from principal investigators and industry clinical study reports.
Data Extraction
2 independent reviewers selected studies and extracted data using a prespecified extraction instrument.
Analytic Approach
Qualitative synthesis of demographics, measurement scales, and outcomes. Quantitative synthesis with Mantel-Haenszel risk ratios (RRs), Peto odds ratios (ORs), or (standardized) mean differences (MDs). Risk of bias of included studies at the outcome level was assessed using the Cochrane risk-of-bias tool for RCTs.
Results
19 RCTs that enrolled 1,693 participants were meta-analyzed. Ultrafiltration was improved with icodextrin (medium-term MD, 208.92 [95% CI, 99.69-318.14] mL/24 h; high certainty of evidence), reflected also by fewer episodes of fluid overload (RR, 0.43 [95% CI, 0.24-0.78]; high certainty). Icodextrin-containing PD probably decreased mortality risk compared to glucose-only PD (Peto OR, 0.49 [95% CI, 0.24-1.00]; moderate certainty). Despite evidence of lower peritoneal glucose absorption with icodextrin-containing PD (medium-term MD, −40.84 [95% CI, −48.09 to −33.59] g/long dwell; high certainty), this did not directly translate to changes in fasting plasma glucose (−0.50 [95% CI, −1.19 to 0.18] mmol/L; low certainty) and hemoglobin A1c levels (−0.14% [95% CI, −0.34% to 0.05%]; high certainty). Safety outcomes and residual kidney function were similar in both groups; health-related quality-of-life and pain scores were inconclusive.
Limitations
Trial quality was variable. The follow-up period was heterogeneous, with a paucity of assessments over the long term. Mortality results are based on just 32 events and were not corroborated using time-to-event analysis of individual patient data.
Conclusions
Icodextrin for once-daily long-dwell PD has clinical benefit for some patients, including those not meeting ultrafiltration targets and at risk for fluid overload. Future research into patient-centered outcomes and cost-effectiveness associated with icodextrin is needed. en-copyright= kn-copyright= en-aut-name=GoossenKäthe en-aut-sei=Goossen en-aut-mei=Käthe kn-aut-name= kn-aut-sei= kn-aut-mei= aut-affil-num=1 ORCID= en-aut-name=BeckerMonika en-aut-sei=Becker en-aut-mei=Monika kn-aut-name= kn-aut-sei= kn-aut-mei= aut-affil-num=2 ORCID= en-aut-name=MarshallMark R. en-aut-sei=Marshall en-aut-mei=Mark R. kn-aut-name= kn-aut-sei= kn-aut-mei= aut-affil-num=3 ORCID= en-aut-name=BühnStefanie en-aut-sei=Bühn en-aut-mei=Stefanie kn-aut-name= kn-aut-sei= kn-aut-mei= aut-affil-num=4 ORCID= en-aut-name=BreuingJessica en-aut-sei=Breuing en-aut-mei=Jessica kn-aut-name= kn-aut-sei= kn-aut-mei= aut-affil-num=5 ORCID= en-aut-name=FiranekCatherine A. en-aut-sei=Firanek en-aut-mei=Catherine A. kn-aut-name= kn-aut-sei= kn-aut-mei= aut-affil-num=6 ORCID= en-aut-name=HessSimone en-aut-sei=Hess en-aut-mei=Simone kn-aut-name= kn-aut-sei= kn-aut-mei= aut-affil-num=7 ORCID= en-aut-name=NariaiHisanori en-aut-sei=Nariai en-aut-mei=Hisanori kn-aut-name= kn-aut-sei= kn-aut-mei= aut-affil-num=8 ORCID= en-aut-name=SloandJames A. en-aut-sei=Sloand en-aut-mei=James A. kn-aut-name= kn-aut-sei= kn-aut-mei= aut-affil-num=9 ORCID= en-aut-name=YaoQiang en-aut-sei=Yao en-aut-mei=Qiang kn-aut-name= kn-aut-sei= kn-aut-mei= aut-affil-num=10 ORCID= en-aut-name=ChangTae Ik en-aut-sei=Chang en-aut-mei=Tae Ik kn-aut-name= kn-aut-sei= kn-aut-mei= aut-affil-num=11 ORCID= en-aut-name=ChenJinBor en-aut-sei=Chen en-aut-mei=JinBor kn-aut-name= kn-aut-sei= kn-aut-mei= aut-affil-num=12 ORCID= en-aut-name=PaniaguaRamón en-aut-sei=Paniagua en-aut-mei=Ramón kn-aut-name= kn-aut-sei= kn-aut-mei= aut-affil-num=13 ORCID= en-aut-name=TakatoriYuji en-aut-sei=Takatori en-aut-mei=Yuji kn-aut-name= kn-aut-sei= kn-aut-mei= aut-affil-num=14 ORCID= en-aut-name=WadaJun en-aut-sei=Wada en-aut-mei=Jun kn-aut-name= kn-aut-sei= kn-aut-mei= aut-affil-num=15 ORCID= en-aut-name=PieperDawid en-aut-sei=Pieper en-aut-mei=Dawid kn-aut-name= kn-aut-sei= kn-aut-mei= aut-affil-num=16 ORCID= affil-num=1 en-affil=Institute for Research in Operative Medicine, Faculty of Health, Department of Medicine, Witten/Herdecke University kn-affil= affil-num=2 en-affil=Institute for Research in Operative Medicine, Faculty of Health, Department of Medicine, Witten/Herdecke University kn-affil= affil-num=3 en-affil=Baxter Healthcare (Asia) Pte Ltd kn-affil= affil-num=4 en-affil=Institute for Research in Operative Medicine, Faculty of Health, Department of Medicine, Witten/Herdecke University kn-affil= affil-num=5 en-affil=Institute for Research in Operative Medicine, Faculty of Health, Department of Medicine, Witten/Herdecke University kn-affil= affil-num=6 en-affil=Baxter Healthcare International kn-affil= affil-num=7 en-affil=nstitute for Research in Operative Medicine, Faculty of Health, Department of Medicine, Witten/Herdecke University kn-affil= affil-num=8 en-affil=Baxter Japan Ltd kn-affil= affil-num=9 en-affil=Baxter Healthcare International kn-affil= affil-num=10 en-affil=Baxter (China) Investment Co. Ltd kn-affil= affil-num=11 en-affil=Department of Internal Medicine, NHIS Medical Center kn-affil= affil-num=12 en-affil=Division of Nephrology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital, Chang Gung University College of Medicine kn-affil= affil-num=13 en-affil=Research Unit, Unidad de Investigación Médica en Enfermedades Nefrológicas, Centro Médico Nacional Siglo XXI, Instituto Mexicano del Seguro Social (IMSS) kn-affil= affil-num=14 en-affil=Internal Medicine, Rijinkai Medical Foundation, Socio-Medical Corporation, Kohsei General Hospital kn-affil= affil-num=15 en-affil=Department of Nephrology, Rheumatology, Endocrinology and Metabolism, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences kn-affil= affil-num=16 en-affil=nstitute for Research in Operative Medicine, Faculty of Health, Department of Medicine, Witten/Herdecke University kn-affil= END