patients who had both a penile curvature deformity
measurement and a PDQ response at baseline and at least
one subsequent time point after the
f
rst injection of CCH.
The mITT population appropriately excluded patients who
were not sexually active within 3 months of baseline
assessment. These patients were deemed ineligible to
complete the PDQ to help ensure the accuracy of patient
recall.
The subgroup analyses examined change in penile curvature
deformity and PDQ PD symptom bother scores from baseline
to week 52, using the last observation carried forward
approach for patients who did not have an evaluation at week
52. Within each subgroup, the CCH-treated group was
compared with placebo using
ANOVA
with a factor for
treatment group and either percent change in curvature
deformity or change from baseline in symptom bother score.
Results
The full demographic characteristics of the present study
population are reported by Gelbard et al. [20]. IMPRESS I
and II each included 418 randomized participants (IMPRESS
I,
n
=
278 to CCH and
n
=
140 to placebo; IMPRESS II,
n
=
277 to CCH and
n
=
141 to placebo). The mITT
population for IMPRESS I was 303 (
n
=
199 for CCH and
n
=
104 for placebo), and the mITT population for
IMPRESS II was 309 (
n
=
202 for CCH and
n
=
107 for
placebo).
Baseline Penile Curvature Deformity
Results for the co-primary endpoints in patients with either
30
–
60
°
or 61
–
90
°
baseline penile curvature are shown in
Fig. 1. A total of 492 patients had a baseline penile curvature
of 30
–
60
°
(
n
=
318 for CCH and
n
=
174 for placebo), and
120 patients had a baseline penile curvature of 61
–
90
°
(
n
=
83 for CCH and
n
=
37 for placebo).
Signi
f
cantly greater improvements were observed in the CCH
treatment groups compared with the placebo groups in
percent change in penile curvature deformity for both the
30
–
60
°
curvature group (14.8
°
decrease for CCH, 7.6
°
for
placebo, a 33.8 vs 17.1% reduction, respectively;
P
<
0.001)
and the 61
–
90
°
curvature group (25.3
°
decrease for CCH,
17.0
°
for placebo, a 35.0 vs 23.3% reduction, respectively;
P
=
0.008). Signi
f
cantly greater improvement in the PD
symptom bother domain score was observed in the 30
–
60
°
group between the CCH treatment and placebo groups
(
P
=
0.004). In the 61
–
90
°
group, the difference between
CCH treatment and placebo approached but did not reach
statistical signi
f
cance (
P
=
0.071).
Duration of Disease at Baseline
Table 1 is a summary of co-primary endpoint results for
patients with a PD duration of 1
–
2 years,
>
2to
≤
4 years, or
>
4 years. At baseline, 201 patients had a duration of PD of
1
–
2 years, 212 had a duration of
>
2to
≤
4 years, and 199 had
a duration of
>
4 years.
Signi
f
cant improvements in mean percent penile curvature
deformity were observed in CCH-treated patients compared
with placebo in the
>
2to
≤
4-years group (
P
<
0.001), and the
>
4-years group (
P
<
0.001), although not in the 1
–
2-years
group (
P
=
0.28). For PD symptom bother, signi
f
cant
improvement was observed in CCH-treated patients
compared with placebo in the
>
4-years group (
P
=
0.01),
although not in the 1
–
2-years group (
P
=
0.14) or the
>
2to
≤
4-years group (
P
=
0.07).
0
5
10
15
20
25
30
35
40
45
50
30° to 60°
60° to 90°
Mean percent change in penile curvature
CCH
Placebo
CCH
Placebo
n
= 83
n
= 37
0
0.5
1
1.5
2
2.5
3
3.5
4
30° to 60°
60° to 90°
Change in PD symptom bother score
P
= 0.004
P
= 0.071
P
< 0.001
P
= 0.008
n
= 318
n
= 174
n
=318
n
= 174
n
= 83
n
= 37
B
A
Fig. 1
Change in (
A
) penile curvature and (
B
) Peyronie
’
s disease symptom bother from baseline to week 52 (last observation carried forward) by
baseline penile curvature. Bold text indicates statistical signi
f
cance. CCH, collagenase
Clostridium histolyticum
.
652
© 2015 The Authors
BJU International © 2015 BJU International
Lipshultz
et al.