ORLANDO—Allowing 1, 2, or 3 days or more between the first and second injection of collagenase clostridium histolyticum (CCH) does not impact the safety or efficacy of the medication in improving penile curvature deformity in men with Peyronie’s disease (PD), researchers reported at the American Urological Association 2014 annual meeting.
“This data supports flexibility in planning CCH treatment cycles without loss of efficacy,” Larry I. Lipshultz, MD, of Baylor College of Medicine in Houston, and colleagues concluded based on a study of 828 PD patients. The investigators evaluated the effect of time between the first and second injection of CCH within the first treatment cycle on penile curvature deformity. The group consisted of 548 men treated with CCH and 280 treated with placebo.
Investigators stratified men by time period between injections (1 day, 2 days, and 3 or more days). The mean percent improvement in penile curvature deformity from baseline to week 6 was 12.1%, 13.7%, and 12.2%, respectively, in the CCH arm and 5.8%, 4.8%, and 12.4%, respectively, in the placebo group.
The most common treatment-related adverse events (AEs) reported during cycle 1 were penile hematoma, penile swelling, and penile pain. All AEs occurred at the injection site and were mild or moderate in severity, according to the investigators.