Beste apotheek van Nederland

C-50
Author
Funding
N; study design; eligibility
Participants
characteristics
Diagnosis details Intervention Outcomes
Meuleman
(2001) 51
Companion
study 36
Funding
source: NR
N screened = NR
N randomized = 315
IG, n = 159
CG, n = 156
ITT analysis used for
primary outcome: Yes
Inclusion: men 18 or older,
with clinical diagnosis of ED
for at least mo; in stable
relationship with female
partner for more than 6 mo
Exclusion: sign genital
anatomical deformities (e.g.
Peyronie’s dx); primary
diagnosis of other sexual
disorders;
hyperprolactinemia; hx of
major haematological, renal
or hepatic abnormalities;
poorly controlled major
psychiatric disorder; ED
attributable to SCI; poorly
controlled diabetes or
untreated proliferative
diabetic retinopathy;
occurrence of CVD, stroke
or MI within 6 mo before
study; tx with anticoagulants,
androgens, trazodone or
nitrates
Age, mean
(range): 55 (24­
77) vs. 54 (23-82)
y
Race (%): NR
Co-morbidities, n
(%):
Diabetes: 25 (16)
vs. 24 (15);
hypertension: 33
(21) vs. 30 (19);
Ischemic heart dx
21 (13) vs. 10 (6);
pelvic surgery 33
(21) vs. 27 (17)
Previous ED
treatment: NR
Smoking status:
NR
Body weight: NR
Concomitant
medications: NR
Duration of ED,
mean (range): 4.8
(1-35) vs. 5 (1-27) y
Underlying
disease: NR
Psychogenic ED:
50 (32)
Physiologic ED, n
(%): 46 (29)
Mixed ED, n (%):
60 (38) vs. 54 (35)
Other types of ED,
n (%): 0 vs. 3 (2)
IG: Sildenafil citrate
CG: Placebo
IG1:
Dose: 25 mg titrated to
50 mg 100 mg at any of
5 times during tx period
Duration: 28 wk
Frequency: once daily,
one hr before sexual
activity
Compliance: NR
CG:
Dose: Placebo
Duration: 28 wk
Frequency: once daily,
one hr before sexual
activity
Compliance: NR
Run In period: 4 wk
Wash out period: NA
F/u duration: 12 wks
and 26 wks post tx
Primary outcome results:IIEF- at 12
wks (values very close to 26 wks
result), mean (SEM)
IIEF, Q3=Q4: pre=2 (2); Post 2 (0.2) vs.
4 (0.2)
IIEF, EF: pre=12 (0.7); Post tx: 13 (0.7)
vs. 21 (0.7)
IIEF, OF: pre=6 (0.3); Post 6 (0.3) vs. 8
(0.3)
IIEF, IS: pre=7 (0.4); Post: 8 (0.3) vs. 11
(0.4)
IIEF, OS: pre=5 (0.2); post: 5 (0.2) vs. 7
(0.2)
IIEF, SD: pre=6 (0.2); Post: 6 (0.2) vs. 7
(0.1)
Other outcomes assessed: event log
reports; partner satisfaction
Withdrawals/drop-outs/loss to f/u: 35
(22) vs.77 (49) stopped tx
WDAE, n (%): 5 (3) vs. 1 (<1);
headache (3) and colour tinge to vision,
dizziness, diarrhoea, nausea, and
intermittent stomach ache in IG, one
headache in CG
TAE, n (%): NR; most common:
flushing, headache, dyspepsia, and
rhinitis; abnormal vision in IG 2 (1), star
vision, colour perception
SAE, n (%): 8 (5) vs. 6 (4); two death in
IG, one due to accident and one cardiac
arrest 1 mo post last dose
Ascertainment of outcomes
assessed: IIEF; GAQ; diary log