Beste apotheek van Nederland

C-133
Author
Funding
N; study design; eligibility
Participants
characteristics
Diagnosis details Intervention Outcomes
Yip (2006) 144
Funding
source: Lilly
Research
Laboratories
N screened =
N randomized = 242 (17
centres across China)
IG1, n = 159
CG, n = 83
ITT analysis used for
primary outcome: NR
Inclusion: men 18 or older
with ED of at least 3 mo in
duration of Psychogenic,
organic or mixed causes
Exclusion: ED caused by
premature ejaculation, or
untreated endocrine
disease; pelvic surgery,
including radical
prostatectomy; penile
deformity, or penile implant,
renal or hepatic
insufficiency, uncontrolled
DM, unstable CVD, hx of
central nervous system
injury, HIV infection
(discretionary criteria: prior
ineffective tx with sildenafil)
Age, mean
(range): 54 (28­
78) y
Race:
East/Southeast
Asian 97%
Co-morbidities, n
(%): DM 31%;
hypertension 30%;
benign prostatic
hyperplasia 22.9%
vs. 17.6;
hypercholeserole
mia 6% vs. 11%
Previous ED
treatment: NR
Smoking status:
NR
Body weight:
70.3 (9.4) vs.68.6
(9.5) kg
Concomitant
medications, n (%):
NR
Duration of ED: pts
with ED longer than
1 y, n (%) 131 (82.4)
vs. 76 (91.6)
Underlying
disease, n (%): NR
Psychogenic ED, n
(%): 22 (13.8) vs.
19 (22.9)
Physiologic ED, n
(%): 94 (59.1) vs. 54
(65.1)
Mixed ED, n (%): 43
(27) vs. 10 (12)
ED severity, n (%):
severe 26%;
moderate 33%; mild
41%
Baseline IIEF-EF,
mean: 14.9 vs. 14.8
IG: Tadalafil
CG: placebo
IG1:
Dose: 20 mg
Duration: 12 wks
Frequency: on demand,
up to once/d
Compliance: NR
CG:
Dose: NA
Duration: 12 wks
Frequency: on demand,
up to once/d
Compliance:
Run In period: 4 wks
Wash out period: NA
F/u duration: 12 wks
Primary outcome results:
Change in mean from baseline:
IIEF-EF: 8.5 vs. 2.1, P<0.001
IIEF-Q3: 1.3 vs. 0.2, P<0.001
IIEF-Q4: 1.7 vs. 0.5, P<0.001
SEP-2, % yes: 30.1 vs. –1.2, P<0.001
SEP-3, % yes: 46.7 vs. 8.9, P<0.001
GAQ-1, % improved: 86.2 vs. 30.1
GAQ-2, % improved: 80.5 vs. 28.9
Other outcomes assessed: IIEF-EF
based on severity of ED (% of pts in
each grp), mean change in score:
Mild (39% vs. 42%) 5.3 vs. –0.3
Moderate (35% vs. 30) 9.1 vs. 2.7
Severe (25.8% vs. 26.5%) 12.5 vs. 5.2
Withdrawals/drop-outs/loss to f/u, n
(%): 12 (5) [5 (3) vs. 7 (8)]
WDAE, n (%): 2 (<1) vs. 1 (<1)
TAE, n (%): AE in 3% or more46 (28.9)
vs. 6 (7.2); included headache, back
pain, dizziness, dyspepsia, and myalgia
SAE, n (%): 3 (1.8) vs. 1 (1.2) including
a worsening of CAD, fractures and
dengue fever in IG; DM & sepsis in CG
Ascertainment of outcomes
assessed: IIEF, GAQ, SEP