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Re: Limited success with clostridium collagenase histolyticum following FDA approval for the treatment of Peyronie’s disease

International Journal of Impotence Research volume 32, pages 251–252 (2020)Cite this article

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Clostridium Collagenase Histolyticum (CCH) is the only FDA approved medication for the treatment of Peyronie’s Disease (PD). CCH was approved in December 2013 after two randomized, double blind, placebo-controlled trials named the Investigation for Maximal Peyronie’s Reduction Efficacy and Safety Studies or IMPRESS trials. Data from IMPRESS I and II trials included 551 patients treated with CCH. Post-hoc meta-analysis of IMPRESS I & II revealed that men treated with CCH experienced a mean 34% improvement in penile curvature, representing a −17.0 ± 14.8 degree change per subject, compared with an 18.2% and −9.3 ± 13.6 degree improvement in those who received placebo (p < 0.0001) [1].

Tsambarlis et al. evaluated the efficacy of CCH for PD in a cohort of 45 men treated at a single high-volume referral center. Interestingly, the authors reported astonishingly different results from the IMPRESS trials, with a statistically insignificant 5.4° improvement in their entire cohort. However, a statistically significant improvement of 11.6° was achieved among men who completed all four cycles of CCH [2]. While this new data make CCH appear to be substantially less effective than in previously published reports, we must consider possible factors influencing their outcomes. This cohort is small by comparison to other published studies [3].

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References

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  1. University of Miami, Miami, USA

    Thomas Masterson, Premal Patel & Ranjith Ramasamy

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  1. Thomas Masterson
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  2. Premal Patel
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  3. Ranjith Ramasamy
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Correspondence to Thomas Masterson.

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TM and RR are the recipients of an investigator-initiated research grant from Endo Pharmaceuticals

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Masterson, T., Patel, P. & Ramasamy, R. Re: Limited success with clostridium collagenase histolyticum following FDA approval for the treatment of Peyronie’s disease. Int J Impot Res 32, 251–252 (2020). https://doi.org/10.1038/s41443-019-0127-x

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