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

Authors

Käthe Goossen, Institute for Research in Operative Medicine, Faculty of Health, Department of Medicine, Witten/Herdecke University, Cologne, Germany.
Monika Becker, Institute for Research in Operative Medicine, Faculty of Health, Department of Medicine, Witten/Herdecke University, Cologne, Germany.
Mark R. Marshall, Baxter Healthcare (Asia) Pte Ltd, Singapore; School of Medicine, University of Auckland, New Zealand; Department of Renal Medicine, Counties Manukau District Health Board, New Zealand. Electronic address: markrogermarshall@icloud.com.
Stefanie Bühn, Institute for Research in Operative Medicine, Faculty of Health, Department of Medicine, Witten/Herdecke University, Cologne, Germany.
Jessica Breuing, Institute for Research in Operative Medicine, Faculty of Health, Department of Medicine, Witten/Herdecke University, Cologne, Germany.
Catherine A. Firanek, Baxter Healthcare International, USA.
Simone Hess, Institute for Research in Operative Medicine, Faculty of Health, Department of Medicine, Witten/Herdecke University, Cologne, Germany.
Hisanori Nariai, Baxter Japan Ltd, Japan.
James A. Sloand, Baxter Healthcare International, USA.
Qiang Yao, Baxter (China) Investment Co. Ltd, China.
Tae Ik Chang, Department of Internal Medicine, NHIS Medical Center, Ilsan Hospital, Korea.
JinBor Chen, Division of Nephrology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital, Chang Gung University College of Medicine, Taiwan.
Ramón Paniagua, Research Unit, Unidad de Investigación Médica en Enfermedades Nefrológicas, Centro Médico Nacional Siglo XXI, Instituto Mexicano del Seguro Social (IMSS), México.
Yuji Takatori, Internal Medicine, Rijinkai Medical Foundation, Socio-Medical Corporation, Kohsei General Hospital, Japan.
Jun Wada, Department of Nephrology, Rheumatology, Endocrinology and Metabolism, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Japan.
Dawid Pieper, Institute for Research in Operative Medicine, Faculty of Health, Department of Medicine, Witten/Herdecke University, Cologne, Germany.

Document Type

Journal Article

Publication Date

6-1-2020

Journal

American journal of kidney diseases : the official journal of the National Kidney Foundation

Volume

75

Issue

6

DOI

10.1053/j.ajkd.2019.10.004

Keywords

HRQoL; Icodextrin; PD solution; PD technique survival; UF volume; dialysate; end-stage kidney disease (ESKD); fluid overload; glucose; long-dwell; meta-analysis; mortality risk; patient survival; peritoneal dialysis (PD); renal failure; renal replacement therapy (RRT); residual urine volume; safety; systematic review; ultrafiltration (UF)

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/24h; 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 A 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.

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