Beste apotheek van Nederland

C-18
Author
Funding
N; study design; eligibility
Participants
characteristics
Diagnosis details Intervention Outcomes
Dinsmore, W
(1999) 19
Funding
source: NR
N screened = 127
N randomized = 111
IG, n = 57
CG1, n = 54
CG2, n= 109 (separate
parallel study, no treatment,
age matched, healthy
subjects, single-visit data not
included in this table)
ITT analysis used for
primary outcome: Yes
Inclusion: men older than
18 with clinical diagnosis of
ED of at least 6 mo,
participated in a stable,
heterosexual relationship for
at least 6 mo and to forego
self-injection programs
Exclusion: advanced
vascular, neurological,
endocrine, or anatomic
causes for ED, major
hematologic, renal, or
hepatic abnormalities,
regular use of nitrates, hx of
stroke in the past 6 mo. or
currently active peptic
ulceration, tx with any
experimented drugs in the 3
mo. preceding the study
Age, mean
(range): 56 (30­
78) vs. 55 (29-89)
y
Race (%): NR
Co-morbidities,
%: hypertension
IG 9 vs. 11; DM 7
vs. 7; ischemic
heart disease 1
vs. 1
Previous ED
treatment: NR
Smoking status:
NR
Body weight: NR
Concomitant
medications: NR
Duration of ED (yr):
NR
Underlying
disease: NR
Psychogenic ED
(%): 40 vs. 39 (CG1)
Physiologic ED
(%): 21 vs. 20
Mixed ED (%): 39
vs. 37
IG: sildenafil (selfadministered)
CG: placebo
CG2: no treatment
IG:
Dose: 25 mg (option to
▲ to 50 mg, max. 100
mg)
Duration: 12 wks
Frequency: 1-hr pre
sexual activity but not >
once daily
Compliance: 87 %
CG:
Dose: NA (option to ▲
to 50 mg, max. 100 mg)
Duration: 12 wks
Frequency: 1-hr pre
sexual activity but not >
once daily
Compliance (%): NR
Run In period: 2-4 wks
Wash out period: NR
F/u duration (both on
and off treatment): 12
wks + 2 wks = 14 wks
Primary outcome results:
IIEF-Q1-15, range: pre (except Q11,
and 12) </= 2.52; post tx range 2.77­
3.92 vs. 1.37-3.10, sign ▲ (p < 0.01)
GEQ, % improved: 81% vs. 18%
(p<0.0001)
Grade 3 or 4 erection/mo, mean (event
log): 6.9 vs. 2.4 (p<0.0001)
Successful sexual intercourse attempts:
73% vs. vs. 30% (p<0.0001)
Other outcomes assessed: all IIEF
items
Withdrawals/drop-outs/loss to f/u, n
(%): 14 (13) including 3 in IG, and 11 in
CG discontinued tx due to lack of
efficacy
WDAE: 0
TAE, n (%): 18 (30) vs. 3 (5.5)
headache 7(12%) vs.1 0; flushing 5 (9)
vs. 2 (4); dyspepsia 4(7) vs.1 (2);
abnormal vision 2 (4) vs. 0
SAE, n: nr
Ascertainment of outcomes
assessed: 15-item IIEF; GEQ; event
log with of erection using a 5-point scale
grading system (0 =no sexual activity;
1=almost never; 5=almost always)
(added”)