Beste apotheek van Nederland

C-114
Author
Funding
N; study design; eligibility
Participants
characteristics
Diagnosis details Intervention Outcomes
Guo (2006) 124
Funding
source: Eli Lilly
and Company
N screened = 399
N randomized = 367
IG1, n = 125
IG2, n = 120
CG, n = 122
ITT analysis used for
primary outcome: yes
Inclusion: men 18 or older
in monogamous relationship,
at least 3 mo hx of ED, with
Psychogenic, organic or
mixed cause
Exclusion: hx of radical
prostatectomy; or other
pelvic surgery with
subsequent failure to
achieve erection; renal
insufficiency, hepatobiliary
disease, unstable angina
within the last 6 mo; hx of
MI; coronary artery bypass
graft surgery, or
precutaneous coronary
intervention within 90 d prior
to 1 st visit; hx of HIV
infection; tx with nitrates,
cancer chemotherapy, or
antiandrogens (discretionary
criteria was ineffective tx
with sildenafil)
Age, mean Concomitant
(range): 52 (24­ medications, n (%):
82) y
NR
Race: East/ Duration of ED: pts
South-eastern with ED of 1 y or
100%
longer 341 (92.9)
Co-morbidities, n Underlying
(%): hypertension disease, n (%): no
77 (21); DM 42 specific cause
(11.4); benign
prostatic
Psychogenic ED, n
hyperplasia 14 (%): 59 (16.1)
(3.8);
hyperlipidemia 9 Physiologic ED, n
(2.5)
(%): 107 (29.2)
Previous ED Mixed ED, n (%):
treatment: NR 201 (54.8)
Smoking status: Other: IIEF severity,
NR
n (%)
Normal 3 (0.8)
Body weight: NR Mild 23 (6.3)
Mild/moderate 93
BMI, mean (25.3)
(range): 24.8 Moderate 135 (36.8)
(15.6-50.4) kg/m 2 Sever 113 (30.8)
IIEF-EF baseline,
mean: 13.6 vs. 13.6
vs. 14
IG1:Tadalafil low dose
IG2: Tadalafil high dose
CG: Placebo
IG1:
Dose: 10 mg
Duration: 12 wks
Frequency: on demand
up to once/d
Compliance: NR
IG2:
Dose: 20 mg
Duration: 12 wks
Frequency: as IG1
Compliance: NR
CG:
Dose: NA
Duration: 12 wks
Frequency: as IG
Compliance: NR
Run In period: 4 wks
Wash out period: NA
F/u duration: 12 wks
Primary outcome results:
Change in mean from baseline:
IIEF-EF: 8.1 vs. 8.7 vs. 2.4
IIEF-Q3: 1.4 vs. 1.5 vs. 0.4
IIEF-Q4: 1.4 vs. 1.6 vs. 0.5
SEP-2, % yes: 33.5 vs. 34.8 vs. 7.7
SEP-3, % yes: 50.0 vs. 56.4 vs. 18.3
GAQ, %: 80.9 vs. 85.7 vs. 43.9
Other outcomes assessed:
IIEF-EF based on severity of ED (% of
pts in each grp), mean change in score:
Mild (31 vs. 28 vs. 34) 24 vs. 23.5 vs.
21.9
Moderate (34.2 vs. 35.2 vs. 37.7) 22.3
vs. 23.0 vs. 15.6
Severe (30 vs. 30.4 vs. 30.2) 18.1 vs.
21.6 vs. 10.7
Withdrawals/drop-outs/loss to f/u, n
(%): 10 (8.3) vs. 12 (9.6) vs. 8 (6.6)
WDAE, n (%): 2 (1.7) vs. 2 (1.6) vs. 1
(0.8)
TAE, n (%): in 2% or more 18 (15) vs.
17 (13.6) vs. 4 (3.3) including
headache, back pain, dizziness,
dyspepsia, chest pain, cough
SAE, n (%): 1 death in IG2
Ascertainment of outcomes
assessed: IIEF, GAQ, SEP