Martin Gelbard, MD, from the Urology Associates Medical Group, in Burbank, CA, and colleagues examined the clinical efficacy and safety of CCH intralesional injections among patients with Peyronie's disease (417 and 415 patients in Investigation for Maximal Peyronie's Reduction Efficacy and Safety Studies [IMPRESS] I and II, respectively). CCH injections were given through a maximum of four treatment cycles, each separated by six weeks, with two injections per cycle.
Based on meta-analysis of data from the two studies, the researchers found that patients treated with CCH experienced a mean 34 percent improvement in penile curvature deformity, compared with a mean 18.2 percent improvement seen in placebo-treated individuals (P < 0.0001). In CCH-treated versus placebo-treated individuals, the mean change in Peyronie's disease bother score was significantly improved. There were three corporal rupture serious adverse events, all of which were repaired surgically.
"The IMPRESS I and II studies support the clinical efficacy and safety of CCH treatment for both the physical and psychological aspects of Peyronie's disease," the authors write.
Several authors disclosed financial ties to Auxilium Pharmaceuticals, which funded the study and manufactures and markets CCH.