Beste apotheek van Nederland

C-121
Author
Funding
N; study design; eligibility
Participants
characteristics
Diagnosis details Intervention Outcomes
Nagao (2006) 132
Funding
source: Lilly
Research
Laboratories
N screened = 382
N randomized = 343 (34
Centres in Japan)
IG1, n = 85
IG2=IG3, n = 86/ grp
CG, n = 86
ITT analysis used for
primary outcome: yes
(LOCF)
Inclusion: men 20 or older
with ED of at least 3 mo in
duration
Exclusion: ED due to
primary sexual disorders, hx
of radical prostatectomy,
pelvic surgery, penile
implantation or clinically sign
penile deformity; renal
insufficiency, HIV infection,
CHD, recent hx of MI or
coronary artery bypass,
malignant hypertension;
stroke, angina, or serious
arrhythmia, severe
hepatobiliary disease; tx with
nitrates, alpha-blockers,
cancer chemotherapy, or
antiandrogens, hx of sign
CNS injuries, past
unresponsiveness to
sildenafil
Age, mean: 55.1
y
Race: 100%
Asian
Co-morbidities, n
(%): hypertension
66 (25.7); DM 53
(20.6); benign
prostatic
hyperplasia 35
(13.6);
hyperlipidemia 34
(13.2)
Previous ED
treatment:
sildenafil tx 194
(56.3)
Smoking status:
136 (39.7)
Body weight,
mean: 68.8 kg
Other: alcohol
consumption 259
(75.5)
Concomitant
medications, n (%):
NR
Duration of ED: pts
with ED of at least 1
y 303 (88.3)
Underlying
disease, n (%): no
specific condition
Psychogenic ED, n
(%): 98 (28.6)
Physiologic ED, n
(%): 111 (32.4)
Mixed ED, n (%):
134 (39.1)
Other:
ED severity, n (%):
Mild 128 (37.3)
Moderate 83 (24.2)
Severe 132 (38.5)
IG1-3: Tadalafil (various
doses)
CG: Placebo
IG1-3:
Dose: 5 mg (IG1), 10
mg (IG2), 20 mg (IG3)
Duration: 12 wks
Frequency: as needed,
up to one tablet/d
Compliance: NR
CG:
Dose: NA
Duration: as IG
Frequency: as IG
Compliance: NR
Run In period: 4 wks
Wash out period: NA
F/u duration: 12 wks
Primary outcome results:
IIEF-EF, mean baseline score: 13.9
Post tx: 21.0 vs. 23.2 vs. 23.5 vs. 16.0
IIEF-EF, LS mean by ED severity:
Mild: 26.6 vs. 26.0 vs. 25.3 vs. 21.1
Moderate: 22.7 vs. 24 vs. 23.0 vs. 15.5
Severe: 15.8 vs. 20.2 vs. 21.9 vs. 11.2
SEP-2 mean %
Baseline (from graph): 45
Post tx: 71.2 vs. 81.3 vs. 84.1 vs. 53.6
SEP-3 mean per pts%:
Baseline (graph): 15
Post tx: 51.7 vs. 64.6 vs. 69.4 vs. 27.8
GAQ, %: 76.5 vs. 81.4 vs. 83.7 vs. 31.4
Other outcomes assessed: SEP-2/3
post hoc analysis for ED severity grps
Withdrawals/drop-outs/loss to f/u, n
(%): 8 (9.4) vs. 7 (8) vs. 7 (8) vs. 19
(22); total IG vs. CG 22 (8.6) vs. 19 (22)
WDAE, n (%): 3 (1.2) vs. 0
TAE, n (%): pts with 3% or more AE
104 (40.5) vs. 24 (86)
Ocular hyperemia 3 (3.5) only in IG3
SAE, n (%): 3 (1.2) vs. 0 including
acute prostatitis and pyelonephritis
(IG2); mental disorder (IG3); uretral
calculus (IG1)
Ascertainment of outcomes
assessed: IIEF, SEP, GAQ