Improvement in PD symptom bother was signi

cantly greater

in the patients treated with CCH than in those treated with

placebo in the 1

–

5 (no sexual activity) and

≥

17 (high IIEF-

erectile function) groups. For the 6

–

16 (low IIEF-erectile

function) group, no statistically signi

cant differences were

observed.

Discussion

In these analyses, the clinical ef

cacy of CCH treatment in

reducing penile curvature deformity and PD symptom bother

was demonstrated across various subgroups. This is in

keeping with the results of the combined analysis of

IMPRESS I and II, in which both signi

cant improvement in

penile curvature deformity and PD symptom bother were

observed in CCH-treated patients compared with placebo

[20].

For the groups with baseline penile curvature deformity of

–

and 61

–

, baseline mean PD symptom bother

scores were 7.4 and 7.6, respectively. In conjunction with the

ndings from the same study population that 58.1 and 71.5%

of patients with baseline penile curvature deformity

≤

and

, respectively, were

‘

very bothered

’

‘

extremely

bothered

’

, [8] this suggests that PD symptom bother can

occur regardless of severity of penile curvature deformity.

Signi

cant improvements in penile curvature deformity with

CCH treatment compared with active placebo were observed

at week 52, regardless of baseline penile curvature deformity

strata (30

–

or 61

–

). In addition, a mean decrease in

PD symptom bother domain score was observed in this

analysis, regardless of baseline penile curvature deformity

strata, with differences in the 30

–

group (

0.004) and

the 61

–

group (

0.07).

Treatment with CCH also resulted in improvements in penile

curvature deformity, regardless of disease duration; however,

in the group that was most recently diagnosed (1

–

2 years

before baseline), the difference between CCH and active

placebo was not statistically signi

cant. Reductions in PD

symptom bother with CCH, compared with active placebo,

were observed in each group but were only signi

cant in the

group with the longest duration of disease. The implications

of these

ndings are unclear, as the disease may still be

stabilizing at 1

–

2 years, and, as noted previously, all patients

received injections of diluent as well as home and investigator

modelling.

A relatively small proportion of patients had either non-

contiguous stippling (

76 for CCH and

27 for

placebo) or contiguous calci

cation (

38 for CCH and

24 for placebo) at baseline, compared with no

calci

cation (

287 for CCH and

160 for placebo).

Although similar reductions in mean percent penile curvature

deformity and PD symptom bother were observed in all of

these groups, the small sample sizes in the groups with

calci

cation prevent conclusions from being drawn for those

groups.

Similarly to the results for disease duration, the treatment

bene

ts of CCH were most consistent in the most affected

group of men, as measured by baseline IIEF-erectile function

severity; however, only 22 patients were in the 1

–

5 (no sexual

activity) group, which is insuf

cient to provide the statistical

power necessary for analysis. The fact that the largest group

of patients was the one with high IIEF-erectile function

(

480)isin

teres

ingintha

tind

ica

testha

tthevas

tma

jor

of patients with PD in the present study did not experience

substantial impairment in erectile function.

Some previous studies have examined the ef

cacy of PD

treatments in different subgroups of patients. A study of

multimodal therapy for PD, with or without vitamin E,

examined the subgroup of patients with plaques with a

volume

≤

500 mm

and those with plaques with a volume

500 mm

. That analysis found signi

cantly greater plaque

Table 3

Change in penile curvature and Peyronie

’

s disease symptom bother from baseline to week 52 (last observation carried forward), strati

ed by

baseline International Index of Erectile Function severity score.

IIEF score 1

–

IIEF score 6

–

IIEF score

≥

CCH (

16)

Placebo (

CCH (

67)

Placebo (

39)

CCH (

314)

Placebo (

166)

Mean

penile curvature,

Baseline

53.5

13.5

57.5

13.3

53.0

15.5

51.9

14.6

49.2

14.1

48.4

13.7

Week 52

37.6

13.9

48.2

12.9

37.2

16.4

41.7

16.9

32.0

16.7

39.4

16.1

Change

15.9

14.9

9.3

16.9

15.9

17.6

10.2

11.4

17.2

14.1

9.1

14.0

% Change

28.0

24.2

13.4

26.1

27.6

31.4

20.4

26.3

35.6

28.7

17.9

30.3

0.234

0.227

<0.001

Mean

PDQ PD symptom bother score

Baseline

8.8

4.1

9.5

1.0

9.8

2.7

9.6

3.5

6.9

3.4

7.3

3.6

Week 52

5.9

4.0

9.7

2.0

6.3

4.0

6.8

3.9

4.2

3.7

5.7

4.0

Change

2.9

2.7

0.2

2.6

3.5

3.8

2.9

4.0

2.7

3.8

1.6

3.4

0.026

0.408

0.002

PD, Peyronie

’

s disease; CCH, collagenase Clostridium histolyticum; PDQ, Peyronie

’

s Disease Questionnaire; IIEF, International Index of Erectile Function. Bolded text indicates

statistical signi

cance.

654

Lipshultz

et al.