A randomized controlled trial to evaluate the efficacy and safety of icodextrin in peritoneal dialysis.
BACKGROUND
This article presents the results of two randomized, double-blind, controlled studies conducted to compare the efficacy and long-term safety of icodextrin and 2.5% dextrose for the once-daily long dwell in continuous ambulatory peritoneal dialysis (CAPD) and automated peritoneal dialysis (APD).


METHODS
Both studies were active-control comparisons of 7.5% icodextrin and 2.5% dextrose for the once-daily long dwell. The efficacy study was a 4-week evaluation of net ultrafiltration and peritoneal clearances of creatinine and urea nitrogen in 175 CAPD patients. The 52-week study in CAPD and APD patients examined the long-term safety of icodextrin and longer term effects, such as body weight and quality of life.


RESULTS
Mean net ultrafiltration (587.2 versus 346.2 mL, P < 0.001) and clearances of urea nitrogen (4.5 versus 4.1 mL/min, P < 0.001) and creatinine (4.0 versus 3.5 mL/min, P < 0.001) were increased significantly with icodextrin. Patients receiving icodextrin had no increase in weight after 52 weeks, in contrast to a weight gain of almost 2 kg in the dextrose group (P < 0.05). There were significantly fewer patients reporting edema in the icodextrin group compared with the dextrose group (6.3% versus 17.9%, P < 0.01). There were no statistically significant differences between groups for the incidence and severity of adverse events. There were small decreases in sodium and chloride and increases in alkaline phosphatase with icodextrin.


CONCLUSIONS
Icodextrin provides patients with greater fluid removal and small solute clearance, no weight gain over 52 weeks, and a decreased risk of edema.
Wolfson
Marsha
M
Renal Division, Baxter Healthcare Corporation, McGaw Park, IL 60085-6730, USA. marsha_wolfson@baxter.com
Piraino
Beth
B
Hamburger
Richard J
RJ
Morton
A Ross
AR
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001806:Blood Urea Nitrogen; D001835:Body Weight / Q000187:drug effects; D003404:Creatinine / Q000097:blood / Q000378:metabolism; D004311:Double-Blind Method; D005260:Female; D005936:Glucans / Q000009:adverse effects* / Q000627:therapeutic use*; D005947:Glucose / Q000009:adverse effects* / Q000627:therapeutic use*; D015312:Hemodialysis Solutions / Q000009:adverse effects / Q000627:therapeutic use; D006801:Humans; D000077607:Icodextrin; D008297:Male; D008875:Middle Aged; D010531:Peritoneal Dialysis, Continuous Ambulatory / Q000379:methods*; D011788:Quality of Life; D016896:Treatment Outcome; D014462:Ultrafiltration / Q000379:methods
D005936:Glucans; D015312:Hemodialysis Solutions; D000077607:Icodextrin; D003404:Creatinine; D005947:Glucose