Elmiron: the FINAL word

[dshoskes]

We've known for decades that Elmiron has a modest chance for effect in the short term, barely higher than placebo. Now the definitive study:

J Urol. 2014 Sep 19. pii: S0022-5347(14)04431-0. doi: 10.1016/j.juro.2014.09.036. [Epub ahead of print]
Pentosan Polysulfate Sodium for Treatment of Interstitial Cystitis/Bladder Pain Syndrome: Insights from a Randomized, Double-Blind, Placebo-Controlled Study.
Nickel JC1, Herschorn S2, Whitmore KE3, Forrest JB4, Hu P5, Friedman AJ5, Baseman AS5.
PURPOSE: To compare the efficacy and safety of the currently recommended dose of pentosan polysulfate sodium (PPS) with one-third of the daily dose and with placebo.

MATERIALS AND METHODS: In this multicenter, double-blind, randomized, placebo-controlled study, 368 adults with interstitial cystitis/bladder pain syndrome, defined by total score ≥8 on the interstitial cystitis symptom index (ICSI) and score >0 on the 4 ICSI component items, received PPS 100 mg once (QD), PPS 3 times (TID) daily, or matching placebo for 24 weeks. Eligibility was not based on cystoscopy findings. ICSI was administered at baseline and weeks 4, 8, 12, 18, and 24. An unblinded interim analysis, which was performed after 6 years and 54% of the target number of patients (n=645) were enrolled, resulted in early study termination.

RESULTS: There was no statistically significant difference between either PPS dose group and placebo or between the PPS dose groups for the primary endpoint, defined as responder based on achieving ≥30% reduction from baseline ICSI total score at study end: 40.7% (48/118), 39.8% (51/128), and 42.6% (52/122) for the placebo, PPS 100 mg QD, 100 mg TID groups, respectively. PPS was well tolerated, with similar percentages of patients across groups discontinuing due to an adverse event (10.2% - 13.3%).

CONCLUSIONS: Results from a study including a broad population of patients with symptoms consistent with interstitial cystitis did not demonstrate a treatment-effect (vs. placebo) with PPS at the currently established dose or at one-third of the daily dose.

PMID: 25245489 [PubMed - as supplied by publisher]

[webslave]

Thanks for the update. That's it and that's all of it.