Beste apotheek van Nederland

C-12
Author
Funding
N; study design; eligibility
Participants
characteristics
Diagnosis details Intervention Outcomes
Choi (2002) 13
Funding
source: Pfizer
N screened = 133
N randomized = 133
IG, n = 66
CG, n = 67
ITT analysis used for
primary outcome: Yes
Inclusion: men with ED for
at least 6 mo, in a stable
heterosexual relationship for
6 mo or longer
Exclusion: penile
anatomical abnormalities;
SCI, other co-existing sexual
disorders, serum PRL levels
> 3x upper limit to normal,
low free T (> 0% below
lower limit of normal), major
psychiatric disorder, hx of
alcohol or substance abuse;
hx of haematological, renal,
hepatic dx, MI; stroke,
hypotension, retinitis
pigmentosa, poorly condoled
or causing proliferative
retinopathy DM, use of
drugs associated with
androgen therapy, vacuum
devices or other tx for ED.
Age, mean
(range): 51 (28­
78) vs. 51 (32-67)
y
Race (%): NR
Co-morbidities, n
(%):
Eye disorders 21
(32) vs. 14 (21)
Hypertension: 13
(20) vs. 10 (15)
Hyperplasia of
prostate: 11 (17)
vs. 12 (18); DM:
10 (15) vs. 8 (12)
GI disorders: 6 (9)
vs. 5 (8)
Previous ED
treatment: NR
Smoking status,
n (%): Smokers
25 (37.9) vs. 30
(44.8)
Body weight,
mean (range): 70
(52-102) vs. 71
(50-98)
Concomitant
medications: NR
Duration of ED (yr):
5 vs. 5.6 y
Underlying
disease: NR
Psychogenic ED n
(%): 21 (32) vs. 24
(36)
Physiologic ED: 31
(47) vs. 26 (39)
Mixed ED: 14 (21)
vs. 17 (25)
IG: sildenafil
CG: placebo
IG:
Dose: 50 mg, option for
titration at 2 wks to 100,
or 25 mg
Duration: 8 wks
Frequency: once/d
Compliance (%): 100
CG:
Dose: NA
Duration: 8 wks
Frequency: once/d
Compliance (%): 97
Run In period: 4 wks
Wash out period: NR
F/u duration: NR
Primary outcome results:
IIEF, mean score, IG vs. CG
Q3: baseline=2.5; post tx: 4 vs. 3
Q4: baseline = 2; post tx: 4 vs. 2
EF domain: baseline=13; post tx: 23 vs.
15
IS: baseline= 6; post tx: 11 vs. 8
OF: baseline 5; post tx: 8 vs. 5
SD: baseline=6; post tx: 7 vs. 6
OS: baseline= 4; post tx: 7 vs. 5
GAQ, % yes: 81 vs. 28
Intercourse success, %: 62 vs. 26
Other outcomes assessed: Event logs
of sexual activity
Withdrawals/drop-outs/loss to f/u, n
(%): 2 (3)
WDAE: 0
TAE, n of events (%): 46 (70) vs. 25
(27); AE in at least 3 pts: CV=flushing
21 (32) vs. 3 (5); body as whole: 21 (32)
vs. 9 (13); headache 17 (26) vs. 6 (9);
Upper respiratory tract infection=nasal
congestion: 5 (8) vs. 3 (4); digestive
system events: 8 (12) vs. 9 (14);
dyspepsia 3 (5) vs. 5 (8); special
senses events: 10 (15) vs. 3 (5);
abnormalities in colour vision: 4 (5) vs.
0; abnormal vision 3 (5) vs. 1 (2)
SAE, n (%): 2 (3), in CG
Ascertainment of outcomes
assessed: IIEF, GAQ, also event logs,
12 lead ECG, standard laboratory tests