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Results from Mycophenolate Mofetil trial

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  • Results from Mycophenolate Mofetil trial

    Many of you should remember the Cellcept clinical trial that was suddenly halted a few years ago. It was hoped that Cellcept trial would demonstrate that immunosuppressive therapy could be helpful in the treatment of IC for "some" patients. Unfortunately, Cellcept was associated with increased risk of first trimester pregnancy loss and severe fetal birth defects... hence the cessation of the study. Interestingly, the researchers in this federally funded study did review the small amount of data they collected and concluded that it was no better than placebo in reducing IC symptoms... yet they also state that it could not "refute" the use of immunosuppressants for some patients. Errr, vague enough for you? It would have be interesting to find another immunosuppressant that doesn't pose the same risk to see if it would fare better. - Jill

    Source: Yang CC, Burks DA, Propert KJ, Mayer RD, Peters KM, Nickel JC, Payne CK, Fitzgerald MP, Hanno PM, Chai TC, Kreder KJ, Lukacz ES, Foster HE, Cen L, Landis JR, Kusek JW, Nyberg LM; Interstitial Cystitis Collaborative Research Network.Early Termination of a Trial of Mycophenolate Mofetil for Treatment of Interstitial Cystitis/Painful Bladder Syndrome: Lessons Learned. J Urol. 2011 Jan 14. [Epub ahead of print]

    PURPOSE: We evaluated the efficacy and tolerability of mycophenolate mofetil in patients with treatment refractory interstitial cystitis/painful bladder syndrome.

    MATERIALS AND METHODS: A total of 210 patients with interstitial cystitis/painful bladder syndrome were to be randomized into a multicenter, placebo controlled trial using a 2:1 randomization. Participants in whom at least 3 interstitial cystitis/painful bladder syndrome specific treatments had failed and who had at least moderately severe symptoms were enrolled in a 12-week treatment study. The primary study end point was the global response assessment. Secondary end points were general and disease specific symptom questionnaires, and voiding diaries.

    RESULTS: Only 58 subjects were randomized before a black box warning regarding mycophenolate mofetil safety was issued by the manufacturer in October 2007. The trial was halted, and interim analysis was performed and presented to an independent data and safety monitoring board. Six of the 39 subjects (15%) randomized at study cessation were considered responders for mycophenolate mofetil compared to 3 of 19 controls (16%, p = 0.67). Secondary outcome measures reflected more improvement in controls.

    CONCLUSIONS: In a randomized, placebo controlled trial that was prematurely halted mycophenolate mofetil showed efficacy similar to that of placebo to treat symptoms of refractory interstitial cystitis/painful bladder syndrome. The results of this limited study cannot be used to confirm or refute the hypothesis that immunosuppressive therapy may be beneficial to at least a subgroup of patients with interstitial cystitis/painful bladder syndrome. Despite study termination lessons can be gleaned to inform future investigations.

    Copyright © 2011 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.
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