Beste apotheek van Nederland

C-96
Author
Funding
N; study design; eligibility
Participants
characteristics
Diagnosis details Intervention Outcomes
Nehra (2005) 104
105
Companion
Brock (2003) 105
Funding
source: Bayer
Pharmaceuticals
Corp & Bayer
Inc.
N screened = 567
N randomized = 440
IG1, n = 146 (ITT, n = 135)
IG2, n = 149 (ITT, n = 145)
CG, n = 145 (ITT, n = 134)
ITT analysis for primary
outcome: Yes
Inclusion: men 18 or older,
with ED due to nerve
sparing-radical retro pubic
prostatectomy, between 0.5
and 5 y prior to screening;
localized tumours allowed; 4
attempts at sexual
intercourse on 4 separate d
with a 50% or higher chance
of failure
Exclusion: unstable CV;
Gleason tumour score > 8,
hx of unresponsiveness to
sildenafil due to lack of
efficacy or sign. side effects
leading to discontinuation,
hypoactive SD, low serum T,
DM; prostate cancer.
Age, mean: 60 y
Race, (%): White
99 vs. 87 vs. 93
Co-morbidities, n
(%): depressive
disorder1 (<1) vs.
8 (6) vs. 10 (7);
acute MI 12 (3);
hypertension 130
(30); prostate
hyperplasia 11 (3);
hypercholesterole
mia 91 (21);
vasectomy 44 (10)
Previous ED
treatment, n (%):
338 (77)
BMI, mean: 28
kg/m 2
Smoking status,
(%): 46-55%
previously smoked
Body weight: NR
Other: IIEF EF
score, mean:
pre-operation =23;
baseline =9
Concomitant
medications: NR
Duration of ED,
mean: 1.7 y (post
surgery)
Underlying
disease: nerve
sparing radial retro
pubic prostatectomy
(Mean Gleason
tumour=6)
Psychogenic ED:
NR
Physiologic ED:
100%
Mixed ED: NR
Other:
neurovascular
bundle sparing: n (%
bilateral): 112 (76)
vs. 101 (72) vs. 99
(71)
IG1: Oral Vardenafil
IG2: Oral Vardenafil
CG: placebo
IG1/IG2:
Dose: 10 mg (IG1), 20
mg (IG2)
Duration: 12 wks
Frequency: as needed
but no more than 1x/day
Compliance: NR
CG:
Dose: NA
Duration: 12 wks
Frequency: as IG
Compliance: NR
Run In period: 4 wk tx
free
Wash out period: NA
F/u duration: 12 wks
Primary outcome results:
Last observation carried forward, mean
IIEF- -Intercourse satisfaction, mean:
Baseline, all =5; post tx: 8 vs. 7 vs. 5
IIEF-OF, mean:
Baseline, all=5; post tx: 6 vs. 6 vs. 5
IIEF-OS:
Baseline, all=5; post tx: 6 vs. 6 vs. 5
Hardness of erection, (mean per pts
satisfaction rate %): 28 vs. 24 vs. 8
IIEF-EF score:
Baseline, all =9; post tx 15 vs. 15 vs. 9
Mild-moderate ED: 26 vs. 25 vs. 16
Moderate ED: 23 vs. 19 vs. 13
Severe ED: 11 vs. 13 vs. 7
SEP-Q2, mean per pts success rate
(%): baseline 21 vs. 18 vs. 14
Post tx: 47 vs. 48 vs. 22
SEP-Q3, mean per pts success rates
(%): baseline 7 vs. 7 vs. 6;
post tx 37 vs. 34 vs. 10
GAQ, % yes: 59 vs. 65 vs. 13
Other outcomes assessed: NA
Withdrawals/drop-outs/loss to f/u:
NR
WDAE, (%): 4 vs. 3 vs. < 1%
TAE, (%): Tx emergent AEs 57 vs. 65
vs. 40; including headache 16 vs. 22 vs.
4; Vasodilation 19 vs. 21 vs. 0; Rhinitis
16 vs. 20 vs. 6; Sinusitis 6 vs. 7 vs. 1;
dyspepsia 4 vs. 5 vs. 0; nausea 1 vs. 5
vs. <1
SAE: 1 (<1%) vs. 3 (2%) vs. 1 (<1%)
cause NR
Outcome ascertainment: IIEF; GAQ;
SEP-Q2, and 2