PMID- 25711400
OWN - NLM
STAT- MEDLINE
DCOM- 20151208
LR  - 20220317
IS  - 1464-410X (Electronic)
IS  - 1464-4096 (Linking)
VI  - 116
IP  - 4
DP  - 2015 Oct
TI  - Clinical efficacy of collagenase Clostridium histolyticum in the treatment of 
      Peyronie's disease by subgroup: results from two large, double-blind, randomized, 
      placebo-controlled, phase III studies.
PG  - 650-6
LID - 10.1111/bju.13096 [doi]
AB  - OBJECTIVES: To examine the efficacy of intralesional collagenase Clostridium 
      histolyticum (CCH) in defined subgroups of patients with Peyronie's disease (PD). 
      PATIENTS AND METHODS: The efficacy of CCH compared with placebo, assessed from 
      baseline to week 52, was examined in subgroups of participants from the 
      Investigation for Maximal Peyronie's Reduction Efficacy and Safety Studies 
      (IMPRESS) I and II. The subgroups were defined according to: severity of penile 
      curvature deformity at baseline (30-60 degrees  [n = 492] and 61-90 degrees  [n = 120]); PD 
      duration (1 to </=2 [n = 201], >2 to </=4 [n = 212] and >4 years [n = 199]); degree 
      of plaque calcification (no calcification [n = 447], non-contiguous stippling [n 
      = 103] and contiguous calcification that did not interfere with injection of CCH 
      [n = 62]); and baseline erectile function (International Index of Erectile 
      Function [IIEF] scores 1-5 [n = 22], 6-16 [n = 106] and >/=17 [n = 480]). RESULTS: 
      Reductions in penile curvature deformity and PD symptom bother were observed in 
      all subgroups. Penile curvature deformity reductions were significantly greater 
      with CCH than with placebo for the following subgroups: baseline penile curvature 
      30-60 degrees  and 61-90 degrees ; disease duration >2 to </=4 years and >4 years; no 
      calcification; and IIEF score >/=17 (high IIEF-erectile function score; P < 0.05 
      for all). PD symptom bother reductions were significantly greater in the CCH 
      group for: penile curvature 30-60 degrees ; disease duration >4 years; no calcification; 
      and IIEF score 1-5 (no sexual activity) and >/=17 (P < 0.05 for all). CONCLUSIONS: 
      In this analysis, clinical efficacy of CCH treatment for reducing penile 
      curvature deformity and PD symptom bother was found across subgroups. In the 
      IMPRESS I and II overall, adverse events (AEs) were typically mild or moderate, 
      although treatment-related serious AEs, including corporal rupture or penile 
      haematoma, occurred. Future studies could be considered to directly assess the 
      efficacy and safety of CCH treatment in defined subgroups of PD patients, with 
      the goal of identifying predictors of optimum treatment success.
CI  - (c) 2015 The Authors BJU International (c) 2015 BJU International Published by John 
      Wiley & Sons Ltd.
FAU - Lipshultz, Larry I
AU  - Lipshultz LI
AD  - Scott Department of Urology, Baylor College of Medicine, Houston, TX, USA.
FAU - Goldstein, Irwin
AU  - Goldstein I
AD  - San Diego Sexual Medicine, Alvarado Hospital, San Diego, CA, USA.
FAU - Seftel, Allen D
AU  - Seftel AD
AD  - Cooper University Hospital, Camden, NJ, USA.
FAU - Kaufman, Gregory J
AU  - Kaufman GJ
AD  - Auxilium Pharmaceuticals, Inc., Chesterbrook, PA, USA.
FAU - Smith, Ted M
AU  - Smith TM
AD  - Auxilium Pharmaceuticals, Inc., Chesterbrook, PA, USA.
FAU - Tursi, James P
AU  - Tursi JP
AD  - Auxilium Pharmaceuticals, Inc., Chesterbrook, PA, USA.
FAU - Burnett, Arthur L
AU  - Burnett AL
AD  - Johns Hopkins Medicine, Baltimore, MD, USA.
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20150518
PL  - England
TA  - BJU Int
JT  - BJU international
JID - 100886721
RN  - 0 (Placebos)
RN  - EC 3.4.24.3 (Microbial Collagenase)
SB  - IM
CIN - Nat Rev Urol. 2015 Apr;12(4):184. PMID: 25782171
CIN - BJU Int. 2015 Oct;116(4):503-4. PMID: 26350578
CIN - Eur Urol. 2015 Nov;68(5):908-9. PMID: 26460876
MH  - Adult
MH  - Humans
MH  - Male
MH  - Microbial Collagenase/administration & dosage/*therapeutic use
MH  - Penile Induration/*drug therapy/epidemiology/*physiopathology
MH  - Penis/physiopathology
MH  - Placebos
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Peyronie's disease
OT  - collagenase
OT  - efficacy
OT  - plaque
OT  - subgroups
EDAT- 2015/02/26 06:00
MHDA- 2015/12/15 06:00
CRDT- 2015/02/26 06:00
PHST- 2015/02/26 06:00 [entrez]
PHST- 2015/02/26 06:00 [pubmed]
PHST- 2015/12/15 06:00 [medline]
AID - 10.1111/bju.13096 [doi]
PST - ppublish
SO  - BJU Int. 2015 Oct;116(4):650-6. doi: 10.1111/bju.13096. Epub 2015 May 18.