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Volume 49, Issue 1, Page 172 (January 2007)


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“Biased” Comparison Between ANDY-Disc® and UltraBag® in Patients on CAPD

Karopadi Shivanand Nayak, MD, DNB

Refers to article:
In Reply
Hin-Seng Wong, Teck-Onn Lim, Loke-Meng Ong
American Journal of Kidney Diseases
January 2007 (Vol. 49, Issue 1, Pages 172-173)
Full Text | Full-Text PDF (48 KB)
A Randomized, Multicenter, Open-Label Trial to Determine Peritonitis Rate, Product Defect, and Technique Survival Between ANDY-Disc® and UltraBag® in Patients on CAPD , 27 July 2006
Hin-Seng Wong, Loke-Meng Ong, Teck-Onn Lim, Lai-Seong Hooi, Zaki Morad, Rozina Ghazalli, Wan Shaariah, Yam-Ngo Lim, Ghazali Ahmad, Bak-Leong Goh, Lynster Liaw, Susan Pee, Ming-Lee Lee
American Journal of Kidney Diseases
September 2006 (Vol. 48, Issue 3, Pages 464-472)
Abstract | Full Text | Full-Text PDF (330 KB)

Article Outline

References

Copyright

To the Editor:

In their article, Wong et al1 failed to establish therapeutic equivalence of ANDY-Disc (Fresenius Medical Care, Bad Homburg, Germany) to UltraBag (Baxter, Deerfield, IL) regarding peritonitis. The study is inherently biased against the ANDY-Disc group, in having patients shifted from UltraSet (Baxter, Deerfield, IL) and needing transfer set change. The wash-in period of a month seems inadequate as most peritonitis episodes occurred during first half of study. Nonblinded studies cannot avoid bias.2 ANDY-Disc training methods are not specified. ANDY-Disc patients initiated totally new “connectology,” whereas a shift from UltraSet to UltraBag would have less difficulty and without transfer set change. The authors confess unreliable baseline data. There is lopsidedly high incidence of Staphylococcus coagulase–negative/Staphylococcus epidermidis peritonitis in the ANDY-Disc® group (14 versus 5 episodes). Authors attribute the higher incidence of peritonitis in the ANDY-Disc® group to product defects (which settled dramatically in last quarter). S epidermidis peritonitis is mild, easily treatable, and caused by touch contamination not product defects.3 Biofilms cause relapsing peritonitis necessitating catheter change.3 Did the authors follow this guideline? Disregard S epidermidis peritonitis, then the difference in peritonitis is not statistically significant. More realistic would be to follow-up for 2 years with a longer wash-in period or to compare patients starting 2 systems de novo as done earlier.4 This study showed similar peritonitis rates between the StaySafe double-bag disconnect system (Fresenius Medical Care, Bad Homburg, Germany) and UltraBag. StaySafe and ANDY-Disc are essentially similar except for the solution bag material. Our peritoneal dialysis center uses ANDY-Disc with peritonitis rates of 1 episode in 63.2 patient-months and low Gram-positive coccal peritonitis, suggesting good connectology.5, 6

References 

return to Article Outline

1. 1Wong H-S, Ong L-M, Lim T-O, et al. A randomized, multicenter, open-label trial to determine peritonitis rate, product defect, and technique survival between ANDY-Disc® and UltraBag® in patients on CAPD. Am J Kidney Dis. 2006;48:464–472. Abstract | Full Text | Full-Text PDF (329 KB) | CrossRef

2. 2Daly CD, Campbell MK. Is it possible for studies comparing Y-set, double bag, and standard systems of CAPD to be blinded?. Nephrol Dial Transplant. 2001;16:2440–2441. MEDLINE | CrossRef

3. 3Piraino B, Bailie GR, Bernardini J, et al. Peritoneal dialysis-related infections recommendations: 2005 update. Perit Dial Int. 2005;25:107–131. MEDLINE

4. 4Li PK, Law MC, Chow KM, et al. Comparison of clinical outcome and ease of handling in two double-bag systems in continuous ambulatory peritoneal dialysis: A prospective, randomized, controlled, multicenter study. Am J Kidney Dis. 2002;40:373–380. Abstract | Full Text | Full-Text PDF (57 KB) | CrossRef

5. 5Subhramanyam SV, Sinoj KA, Mary B, Nayak KS. Our experience with new connectology for CAPD. Perit Dial Int. 2005;25(suppl 2):S22;abstr.

6. 6Nayak KS. Overcoming CAPD cost barrier in Asian developing countries. 2002;Presented at the First Asian Chapter Meeting, International Society for Peritoneal Dialysis, December 13-15, Hong Kong.

Head, Department of Nephrology PD Center Global Hospitals, Hyderabad Andhra Pradesh, India

 Support: None. Potential conflicts of interest: None.

PII: S0272-6386(06)01693-3

doi:10.1053/j.ajkd.2006.10.027


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