Pentosan Polysulfate
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Elmiron

Pentosan polysulfate (sold under the name Elmiron) was the first --and only-- oral medication approved by the US FDA for the treatment of interstitial cystitis, also known as painful bladder syndrome. Interstitial cystitis patients struggle with symptoms of urinary frequency, urgency, pressure and/or pain, as well as nocturia (frequent urination at night), dyspareunia (painful intercourse), pain and/or discomfort while sitting in a car, while driving and/or travelling. more...

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The origin/cause of IC is unknown though a number of theories are currently under consideration. Urine cultures are typically negative for infection, yet it is not unusual for patients to believe that they have had infections for years rather than IC. Why? Because the symptoms of an infection are nearly identical to the symptoms of IC.

Diagnosis has been greatly simplied in recent years with the development of two new methodologies. The Pelvic Pain Urgency/Frequency (PUF) Patient Survey, created by C. Lowell Parsons, is a short questionnaire that will help doctors identify if pelvic pain could be coming from the bladder. The KCL Test, aka the Potassium Sensitivity Test, uses a mild potassium solution to test the integrity of the bladder wall. Though the latter is not specific for IC, it has been determined to be helpful in the evaluation of the use of compounds, such as pentosan, which are designed to help repair the GAG layer. The previous "gold standard" test for IC was the use of hydrodistention with cystoscopy. Researchers, however, determined that this visual examination of the bladder wall was also not specific for IC and that the test, itself, can contribute to the development of small glomerulations (aka petechial hemorrhages) often found in IC. Thus, a diagnosis of IC is one of exclusion, as well as a review of clinical symptoms.

Pentosan is believed to work by providing a protective coating to the damaged bladder wall. The critical flaw of the medication, however, is its exceptionally poor bioavailability when taken orally. Research presented late in 2005 by Alza Pharmaceuticals (Metabolism of pentosan polysulfate sodium (PPS) in healthy human volunteers. Xenobiotica. 2005 Aug;35(8):775-84.) demonstrates that more than 84% of the medication is excreted, intact, in feces without providing any beneficial effect. Their research found that only 6% was excreted through urine. Thus, it must be taken for several months for most patients to achieve some benefit. More recently, however, Elmiron has been studied as part of a "rescue instillation" which is placed directly in the bladder and can, perhaps, provide better effectiveness. C. Lowell Parsons has presented a research study which shows a 90% effectiveness in reducing the symptoms of IC patients by using this instillation.

Patients who have taken pentosan orally report a variety of side effects, primarily GI complaints such as diarrhea, heartburn, stomach pain. Hair loss, headache, rash, insomnia have also been reported. One concern is the potential for blood thinning with this medication. Some patients have reported that they bruise more easily. In some cases, patients are asked to stop medication before any major surgical procedures to reduce the likelihood of bleeding.

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Researchers Report Relief of IC Symptoms with Pentosan Polysulfate - interstitial cystitis
From American Family Physician, 8/15/01 by J. Curtis Nickel

(96th Annual American Urological Association Meeting) The findings of the first study conducted to evaluate the onset of effect and dose-response relationship of pentosan polysulfate sodium (Elmiron) in the treatment of interstitial cystitis (IC) indicate that significant improvement of symptoms occurrs with duration of therapy in relation to differences in dosages. The 32-week, randomized, double-blind, multicenter study enrolled 380 patients with a positive cystoscopic examination or a history of IC symptoms of at least six months' duration. Patients were randomized to receive 100, 200 or 300 mg of pentosan or placebo three times daily. Measurement tools included the Patient's Overall Rating of Symptom Index (PORIS) and the O'Leary-Sant Interstitial Cystitis Symptom Index. Patients who showed 50 percent or more improvement on PORIS were considered responders. Of the 230 patients who completed the study, 23.1 percent who received 300 mg per day, 16.5 percent who received 600 mg per day and 16.9 percent who received 900 mg per day were responders. At 32 weeks, the percentages rose to 67.1, 59.5 and 60.1 percent, respectively, leading investigators to suggest that while no significant measure of efficacy was evident between dosages, improvement in symptoms had not plateaued at 32 weeks, and further improvement may be obtained with long-term therapy. Pentosan polysulfate sodium is the only oral medication approved by the U.S. Food and Drug Administration for the treatment of IC.--J. CURTIS NICKEL, m.d., et al., Kingston General Hospital, Ontario, Canada.

COPYRIGHT 2001 American Academy of Family Physicians
COPYRIGHT 2001 Gale Group

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