Beste apotheek van Nederland

C-81
Author
Funding
N; study design; eligibility
Participants
characteristics
Diagnosis details Intervention Outcomes
Young (2002) 83
Funding
source: Pfizer
Inc.
N screened = blacks (B)
310, Hispanics (H) 257
N randomized = 443 (B, n
=246, H, n = 197); open
label, n = 191 (B=211;
H=144)
IG, n =223 (B= 124, H = 99)
CG, n =220 (B= 122, H =98)
ITT analysis used for
primary outcome: Yes
Inclusion: black American
or Hispanic American, 18 or
older; documented clinical
diagnosis of ED for longer
than 6 mo; in stable
relationship
Exclusion: previous txt with
sildenafil for ED; other
sexual disorders as primary
dx; ▲ PRL levels or low
free-T levels; uncontrolled
DM; hx of stroke or MI within
previous 6 mo; ED as
consequence of SCI;
concomitant use of nitrates,
androgens or trazodone
Age, mean (sd):
B= 53 (25-73) vs.
54 (23-81)
H=55 (31-84) vs.
53 (22-75) y
Race, n (%):
black 246 (56),
Hispanic 195 (44)
Co-morbidities:
% with ≥1 current
medical condition
B= 90; H= 90 vs.
86
Previous ED
treatment: NR
Smoking status
(%): current
B= 38 vs. 31;
H= 18 vs. 26
Body weight,
mean (range):
B=95 (50-182) kg
H= 85 (56-133) kg
Concomitant
medications: %
with any
B= 86 vs. 87
H =80 vs. 75
Duration of ED,
mean (range):
B= 4 (0.3-33) vs. 5.2
(0.3-30)
H= 4 (0.2-43) vs.3
(0.2-20) y
Underlying
disease: NR
Psychogenic ED
(%): B=13; H 10 vs.
11
Physiologic ED
(%): B =56 vs. 54;
H= 66 vs. 60
Mixed ED (%): B 32
vs. 33; H 24 vs. 29
Other:
Severity of ED (%)
Mild to moderate: B=
61 vs. 60, H= 46 vs.
62; Severe, B =31
vs. 30, H =39 vs. 26
IG: sildenafil
CG: placebo
IG:
Dose: 50 mg, option to
titrate to 100 or 25 mg
Duration: 12 wk
Frequency: up to. 1/d,
one hr before sexual
intercourse
Compliance (%): NR
CG:
Dose: placebo
Duration: 12 wk
Frequency: as IG
Compliance (%): NR
Run In period: None
Wash out period:
None
F/u duration: 12 wk
parallel (option to switch
to opposite arm during
the 12 wk parallel
period)+ 12 wk of openlabel
tx extension
(safety results shown)
Other: results reported
for 6 wks post
intervention; n of pts
who switched also
reported
Primary outcome results:
IG vs. CG, (B-H where not equal), mean
score at 6 wks:
IIEF, Q3: pre: 2.6-2.4; post: 4 vs. 3
IIEF, Q4: pre: 2; post 4 vs. 3
IIEF, EF: pre 14; post 23 vs. 18-16
IIEF, OF: pre 6; post: 8 vs. 6-7
IIEF, SD: pre 7; post 7 vs. 7-6
IIEF, ICs: pre: 6-7; post 11 vs. 9-8
IIEF, OS: pre 4-5; post 8 vs. 6
GEQ-Q1, %: B: 79 vs. 38; H: 82 vs. 30
GEQ-Q2, %: B: 81 vs. 36; H: 80 vs. 29
GEQ-Q3: B: 4 vs. 3; H: 3.5 vs. 2.5
Other outcomes assessed: barriers to
tx; subgrp ED severity; EDITS, EPQ
Withdrawals/drop-outs/loss to f/u: B:
6 (5) vs. 10 (10); H: 13 (11) vs. 9 (9)
Open label phase, B: 20 (9), H: 19 (13)
WDAE, n (%): B=0; H: 2 (2) vs. 0
TAE, n (%): 12 wks, B: 18 (15) vs. 3
(3); H: 27 (22) vs. 11 (11); most
common, % in IG/ pts switched to IG vs.
CG: headache B: 11 vs. 2; H: 16/12 vs.
7; vasodilation B: 2 vs. 0; H: 7/9 vs. 2;
rhinitis B: 2 vs. 0; H: 2/4 vs. 0; nausea
B: 1 vs. 0, H: 2/1 vs. 0; dizziness B: 0;
H: 3/1 vs. 0; abnormal vision B: 2 vs. 0,
H: 2/1 vs. 0
SAE, n (%): 1 (<1) in IG (H)
Ascertainment of outcomes
assessed: IIEF, GAQ; EDITS; erection
problem question (EPQ)