Beste apotheek van Nederland

C-14
Author
Funding
N; study design; eligibility
Participants
characteristics
Diagnosis details Intervention Outcomes
Christiansen
(2000) 15
Funding
source: Pfizer
Ltd.
N screened = NR
N randomized = 205
IG, n = 99
CG, n = 106
ITT analysis used for
primary outcome: Yes
Inclusion: men 18-70 y with
ED of psychogenic or mixed
organic/psychogenic
etiology for at least 3 mo; at
least 1 grade 3 or 4 erection
during 4 wk before
screening or positive
response to IC injection test
(papaverine ≤40 mg or PgE 1
≤20 μg)
Exclusion: known vascular,
neurological, endocrine or
penile anatomical cause for
ED; hx of major
hematologic, renal or
hepatic abnormality; stroke,
subarachnoid haemorrhage,
bleeding disorder or peptic
ulceration; elevated serum
PRL level; low serum T
level; moderate to severe
hyper/ hypotension; regular
tx with nitrates,
anticoagulants, major
tranquillizers, estrogens or
antiandrogens
Age, mean (sd):
53 (19-70) vs. 54
(21-70) y
Race (%): NR
Co-morbidities,
%: Most frequent:
Hypertension 14
Ischemic heart
disease 12
Diabetes 7
Depression 5
Previous ED
treatment, n (%):
IC injections 86
(42)
Smoking status:
NR
Body weight: NR
Concomitant
medications: NR
Duration of ED,
mean (range): 4.8
(0.3-20) vs.5.3 (0.3­
23) y
Underlying
disease: NR
Psychogenic ED,
%: 38 vs. 40%
Physiologic ED:
NR
Mixed ED: 62 vs. 60
IG: sildenafil citrate
CG: placebo
IG1:
Dose: 10 or 25 mg, as
determined during 16­
wk tx phase prior to
double-blind study
Duration: 8 wk
Frequency: up to once/d
approximately 1 hr
before sexual activity
Compliance: NR
CG:
Dose: placebo
Duration: 8 wk
Frequency: as IG
Compliance: NR
Run In period: 2 wk
with placebo
Wash out period: NA
F/u duration (both on
and off treatment):
8 wk
Other: 16-wk openlabel
treatment phase
after run-in period to
adjust dosage
Primary outcome results:
IIEF frequency of erections when
sexually stimulated, mean change in
score: ▲ 1.53 vs. ▼ 0.3
Question assessing frequency of
erections lasting long enough:
IG1 ▲ 1.72, CG ▼ 0.13
Mean number of grade 3 or 4 erections
per wk: 1.5 vs. 0.6
GAQ, % yes: 82 vs. 26
Other outcomes assessed: NA
Withdrawals/drop-outs/loss to f/u, n
(%): 3 (3), all in IG1
WDAE, n (%): 4 (3), no grp designation
TAE: NR, most frequent AEs in IG vs.
CG/ IG in 1 y open label, n (%):
headache 6 (6) vs. 2 (2)/19 (10);
dyspepsia. 5 (5) vs. 3 (3)/26 (14);
flushing 7 (7) vs. 1 (1)/24 (13);
abdominal pain 0 vs. 4 (4)/10 (5);
diarrhoea 1 (1) vs. 0; nausea 1 (1) vs.
0/4 (2); back pain 2 (1) vs. 1 (1)/11 (6);
asthenia 2 (2) vs. 0/3 (2); abnormal
vision including colour hue or brightness
perception 2 (2) vs. 0/4 (2);
conjunctivitis 2 (2) vs. 0/4 (2)
SAE: 24 no grp designation, including
MI in open label phase
Ascertainment of outcomes
assessed: IIEF, GAQ, Patient diary of
grading erection (1=enlarged but not
hard-4=full erection)