Time To Initiation Of Pentosan Polysulfate Sodium Treatment After Interstitial Cystitis Diagnosis: Effect On Symptom Improvement

Main Category: Urology / Nephrology
Also Included In: Infectious Diseases / Bacteria / Viruses;  Clinical Trials / Drug Trials
Article Date: 23 Mar 2008 - 0:00 PDT

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UroToday.com - Is Pentosan Polysulfate More Effective When Administered Early In Disease Course?

In 2005, Nickel and colleagues reported the results of a company-sponsored dose ranging trial of pentosan polysulfate sodium (PPS) in the treatment of interstitial cystitis1. This trial was not placebo controlled, and looked at doses of drug ranging from 300 to 600 to 900mg daily over 32 weeks. There was no dose response to PPS, although side effects did show an increase with increased dosage. This current report by Nickel and colleagues looks only at the 128 subjects of the original 380 in the study who received the 300mg per day dosage. A total of 103 met the requirement for early or late treatment in this retrospective review. Early treatment was defined as within 6 months of IC diagnosis, and late treatment defined as treatment initiated 24 months or more after diagnosis.

The Interstitial Cystitis Symptom Score (range 0-20) showed a 1.82 drop or benefit in those treated early, and the Interstitial Cystitis Problem Score (range 0-16) showed a 2.17 benefit in the early treatment group. The authors suggest that early treatment may be more effective than treatment begun after more time has elapsed.

It would have been interesting to see all of the data from all 3 groups in the initial study. Time to diagnosis is an important parameter, but only as it correlates with time from symptom onset, and we can only assume that there is close correlation in this study. Certainly the major caveat in making any conclusions lies in the fairly minimal symptom improvement in the group treated early versus a group treated over 2 years after diagnosis, and the lack of a placebo control. It may be that the authors of this company-supported study are absolutely correct in their conclusion, but without a control group, one doesn't know whether the early onset group is different from the late onset group and whether the natural history of these patients, or regression to the mean in patients with earlier onset, is in part responsible for the minimal improvement noted.

Whether early treatment with medication is useful in BPS/IC is a very important question, the answer to which could change current treatment algorithms which generally suggest non-medical therapy initially. It remains to be answered with a good, placebo-controlled study. Such a study using PPS would be eagerly anticipated.

Urology 71:57-61, 2008
doi:10.1016/j.urology.2007.09.013

(1) Nickel JC, Barkin J, Forrest J et al. Randomized, double-blind, dose-ranging study of pentosan polysulfate sodium for interstitial cystitis. Urology 2005 April;65(4):654-8.

Reported by UroToday.com Contributing Editor Philip M. Hanno, MD, MPH Professor of Urology Division of Urology, Department of Surgery Hospital of the University of Pennsylvania Medical Director Department of Clinical Effectiveness and Quality Improvement University of Pennsylvania Health System Philadelphia, PA

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