Beste apotheek van Nederland

C-88
Author
Funding
N; study design; eligibility
Participants
characteristics
Diagnosis details Intervention Outcomes
Hatzichristou
92 93
(2004)
Funding
source: Bayer
Corporation,
Bayer AG,
GlaxoSmithKline
N screened = NR
N randomized = 323
IG1, n = 157 (ITT, n = 154)
CG, n = 166 (ITT, n = 155)
ITT analysis used for
primary outcome: Yes
Inclusion: men 18 or older
with ED (NIH consensus),
stable heterosexual
relationship for 6 mo or
longer, at least 50% of 4 or
more attempts at sexual
intercourse on 4 separate d
during the 4 wk baseline
period unsuccessful; answer
‘no’ to at least 1 diary
question (IIEF)
Exclusion: penile
abnormalities, primary
hypoactive SD, ED due to
SCI; radical prostatectomy,
unstable angina, poorly
controlled DM, hypertension;
liver or hematologic dx; use
of organic nitrates, other
nitric oxide donors, or potent
CYP3A4; sildenafil use
permitted except for
unresponsiveness or WDAE
in last 7 d prior to screening
Age, mean: 54
vs. 53 y
Race (%): NR
Co-morbidities,
(%): hypertension
34 vs. 24; DM 16
vs. 20;
hyperlipidemia 2
vs. 5; Cardiac dx 9
vs. 6; respiratory,
thoracic
Previous ED
treatment, (%):
Prior sildenafil use
54 vs. 50
BMI, mean: 27
kg/m 2
Smoking status:
Non smoker 61 %
past smokers
Body weight,
mean: 81 vs. 82
kg
Concomitant
medications: NR
Duration of ED,
mean: 2 y
Underlying
disease: NR
Psychogenic ED,
%: 21 vs. 22
Physiologic ED, %:
37 vs. 42
Mixed ED, %: 43 vs.
36
IG: Vardendafil (flexible
dose)
CG: placebo
IG1:
Dose: 10 mg titrated up
or down if desired)
Duration: 12 wks
Frequency: as needed,
no more than 1 dose/d
Compliance: NR
CG:
Dose: placebo (titration
as IG)
Duration: 12 wks
Frequency: as needed,
no more than 1 dose/d
Compliance: NR
Run In period: 4 wks
Wash out period: NR
F/u duration: 12 wk
Other: Titration data, n
(%)
At wk 4- down to 5 mg:
6 (4) vs. 0
At wk 4-up to 20 mg: 95
(61) vs. 136 (88)
At wk 8- down to 5 or 10
mg: 7 (5) vs. 1 (<1)
At wk 8- up to 20 mg:
20 (13) vs. 4 (3)
Primary outcome results:
IIEF- EF, mean: Baseline=12.8; post tx:
24 vs. 16
SEP-Q2 (% yes): 84 vs. 53
SEP-Q3 (% yes): 74 vs. 34
GAQ; (% yes): 86 vs. 33
Erection hardness mean (%): 63 vs. 23
OS (%): 65 vs. 28
Penis enlargement (%): 92 vs. 75
Successful ejaculation (%): 79 vs. 56
(all p<0.005)
Other outcomes assessed: sub-grp by
dose; depression; self confidence
Withdrawals/drop-outs/loss to f/u: 22
(14) vs. 45 (29)
WDAE, n (%): 5 (3) vs. 3 (2); tx
emergent AEs only: abdominal pain,
headache, dysphagia, pneumonia vs.
accidental injury, vascular anomaly, ▲
CPK)
TAE, %: pts with at least one AE = 45
vs. 27 (data provided for AE of 2 or
more incidence= flushing, headache,
rhinitis, flu syndrome, dyspepsia, back
pain, CPK increase, dizziness,
accidental injury, hypertension and QT
interval prolonged); total n of AE= 94
vs. 50
SAE: 4 (2.5) vs. 5 (3); cause NR
Outcome ascertainment: IIEF, GAQ;
SEP question 2 and 3; pts diary