Beste apotheek van Nederland

C-24
Author
Funding
N; study design; eligibility
Participants
characteristics
Diagnosis details Intervention Outcomes
Eardley (2005)
24
Funding
source: Lilly
ICOS LLC
N screened = 411
N randomized = 367
IG1, n = 183 (first period)
IG2, n = 184 (first period)
CG, n = NA
ITT analysis used for
primary outcome: Yes
Inclusion: Pts aged => 18
yr with documented ED of
any aetiology and severity,
in a steady relationship with
the same female partner
naïve to treatment for ED
with drugs inhibiting PDE5
Exclusion: Pts with
endocrine dx, premature
ejaculation, prostatectomy,
pelvic surgery, penile
deformity, sign renal or
hepatic dx, CHF,
Within 6 mo, MI, coronary
artery bypass surgery,
sudden cardiac arrest, SBP
(< 90 - > 170 mmHg) or
diastolic (< 50 - > 100
mmHg), malignant
hypertension, retinitis
pigmentosa, current tx with
nitrates, cancer
chemotherapy, HIV
infection, substance/drug
abuse in last 6 mo
Age, mean (sd):
54 (12) y
Race (%):
Caucasian 92,
Black 4, Asian 3,
other 1.3
Co-morbidities,
(%):
Hyperlipidemia 11,
coronary artery dx
6.5, hypertension
26.4, DM 9.5,
depression 4
Previous ED
treatment: NR
Smoking status,
(%): current = 24
Body weight: NR
Other: current
alcohol use (65%)
Concomitant
medications: no
other ED treatments
Duration of ED: NR
(pts with 1 y or more
ED =74%)
Underlying
disease: NR
Psychogenic ED:
12%
Physiologic ED:
28%
Mixed ED: 60%
Other: ED defined
as consistent
change in the quality
of erection that
adversely affects
subject’s satisfaction
with sexual
intercourse
Other: Mean IIEF
(EF): 14 (6); Severity
of ED: severe
(IIEF1-10): 31%,
moderate (IIEF 11­
16): 30%, mild (IIEF
17-30): 39%
IG1: Sildenafil
IG2: Tadalafil
IG1: Sildenafil
Dose: 25-100 mg
Duration: 12 wks
Frequency: NR
Compliance: NR
IG2: Tadalafil
Dose: 10-20 mg
Duration: 12 wks
Frequency: NR
Compliance: NR
Run In period: 4 wks
Wash out period: 7-10
d
F/u duration: before
and after crossover
24 wks (2 periods of 12
wks)
Other: Dose was
titrated up and down
between 25-100 for
Sildenafil and 10-20 mg
for Tadalafil
Primary outcome results:
Mean least squares change from
baseline for IIEF domains and 95% CI
(IG2 vs. IG1):
EF: 0.5 (-0.07, 1.1)
OF: 0.3 (0.02, 0.5)
SD: 0.2 (0.02, 0.6)
Intercourse satisfaction: 0.17 (-0.1,
0.42)
Mean change in IIEF questions:
erection firmness, intercourse
satisfaction and enjoyment, desire level,
OS, erection confidence: tadalafil >
sildenafil
OS: 0.3 (0.02, 0.5)
SEP, mean change from baseline:
SEP-Q2: 36 vs. 39
SEP-Q3: 53 vs. 58
Other outcomes assessed: mean
scores of IIEF, drug preference
Withdrawals/drop-outs/loss to f/u:
IG1 (1 st ) and IG2 (2 nd ): n=42
IG1 (2 nd ) and IG2 (1 st ): n=39
WDAE: IG1 (1 st ) and IG2 (2 nd ): n=4
IG1 (2 nd ) and IG2 (1 st ): n=7
TAE, n (%): pts with 1 or more AE=125
(34) vs. 128 (35)
SAE, n: 4 (2) vs.5 (3)
Ascertainment of outcomes
assessed: Questionnaires