📃 Paper Title: Clinical efficacy, safety and tolerability of collagenase clostridium histolyticum for the treatment of peyronie disease in 2 large double-blind, randomized, placebo controlled phase 3 studies
🧍 Author: Gelbard
🕒 Year: 2013
📚 Journal: The Journal of Urology
🌎 Country: USA
ㅤContext to the study:
Can you tell me about trials that assessed the treatment of penile curvature deformity with collagenase clostridium histolyticum?
ㅤ✅ Take-home message of study:
This paper evaluated the safety, efficacy and tolerability of collagenase clostridium histolyticum (CCH) for the treatment of Peyronie's disease through two clinical trials (IMPRESS I & IMPRESS II). These trials found that treatment with CCH was associated with significant improvement with penile curvature deformity and sexual function compared to placebo. The medication was also well-tolerated with a favourable safety profile.
ㅤ 2 double-blind, multi-institutional, randomised, placebo-controlled phase 3 trials
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Study participants:
Men were stratified by degree of penile curvature abnormality (30-60 or 61-90), then randomised to CCH or placebo 2:1
Inclusion Criteria:
Adult men diagnosed with Peyronie's disease
Stable penile curvature for at least 3 months
Penile curvature deformity of 30 to 90 degrees
Each treatment cycle (repeated up to 4 cycles) → 2 injections of CCH or placebo → directly injected into primary plaque at point of maximal penile curvature abnormality
Study size:
Total of 417 in IMPRESS-I
277 → CCH
140 → placebo
Total of 415 in IMPRESS-II
274 → CCH
141 → placebo
Thus combined → 551 in CCH and 281 in placebo
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Key study outcomes:
Co-primary outcomes:
Percent change in penile curvature abnormality
CCH → 34% (-17.0+/-14.8 degrees)
Placebo → 18.2% (-9.3+/-13.6 degrees)
p<0.0001
Change in Peyronie disease questionnaire symptom bother score from baseline to 52 weeks
CCH → -2.8+/-3.8
Placebo → -1.8+/-3.5
p=0.0037.
Patients treated with CCH experienced a mean reduction in penile curvature of 17.0 degrees (34%) compared to a 9.3-degree reduction (18%) in the placebo group (p<0.0001).
CCH-treated patients reported a significant improvement in PDQ scores compared to the placebo group (p<0.001).
CCH treatment was generally well-tolerated, with most adverse events being mild or moderate and resolving without intervention.
The most common adverse events were penile haematoma, pain, and swelling.
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Study Limitations:
Duration was relatively short (52 weeks), which may not capture the long-term safety and efficacy of CCH treatment.
Population primarily consisted of patients with less severe penile curvature, potentially limiting the generalisability of the results to those with more severe deformities.
Did not assess the impact of CCH treatment on sexual function / outcomes beyond patient-reported outcomes.
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