Beste apotheek van Nederland

C-128
Author
Funding
N; study design; eligibility
Participants
characteristics
Diagnosis details Intervention Outcomes
Saylan (2006) 139
Funding
source: Lilly
ICOS LLC
N screened = 139
N randomized = 132 (Egypt
and Turkey)
IG, n = 101
CG, n = 31
ITT analysis used for
primary outcome: yes
(LOCF)
Inclusion: men at least 18
y, with ED of at least 3 mo in
duration and any kind of
severity and etiology
Exclusion: ED caused by
premature ejaculation or
untreated endocrine
disease, or after pelvic
surgery or pts receiving
nitrates, antiandrogens or
chemotherapy, sign penile
deformity or penile implant,
clinically sign renal or
hepatic insufficiency, poorly
controlled DM; stroke, MI, or
SCI, unstable cardiovascular
disease; prior ineffective tx
with sildenafil (physician
discretion)
Age, mean
(range): 48.7
(26.6-67.7) vs.
51.7 (27.8-66.1) y
Race: Caucasians
Co-morbidities, n
(%): DM 21 (20.8)
vs. 8 (25.8);
hypertension 10
(9.9) vs. 7 (22.6);
benign prostatic
hyperplasia 4 (4.0)
vs. 2 (6.5);
hypercholesterola
emia 3 (3.0) vs. 1
(3.2);
hyperlipidemia 1
(1.0) vs. 2 (6.5)
UTI 1 (1.0) vs. 2
(6.5)
Previous ED
treatment: NR
Smoking status:
25.6 vs. 32.3%
Body weight:
82.35 kg
Other: alcohol
consumption <7%
Concomitant
medications, n (%):
Duration of ED:
<6 mo: 14%
>/=6 mo: 10 vs.
22.6%
>/= 1 y: 75.2 vs.
64.5%
Underlying
disease, n (%): no
specific condition
Psychogenic ED, n
(%): 11 (10.9) vs. 2
(6.5)
Physiologic ED, n
(%): 31 (30.7) vs. 9
(29)
Mixed ED, n (%): 59
(58.4) vs. 20 (64.5)
Other:
ED severity, n (%):
Mild 35 (34.7) vs. 11
(35.5)
Moderate 38 (37.6)
vs. 12 (38.7)
Sever 28 (27.7) vs. 8
(25.8)
IG: Tadalafil
CG: Placebo
IG:
Dose: 20 mg
Duration: 12 wks
Frequency: on demand,
up to once/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 (3
visits)
Primary outcome results:
Mean change from baseline (SE):
IIEF-EF: 9.3 (0.8) vs. 2.3 (1.6)
-By ED severity:
Mild: 6.3 (n=32) vs. 0.2 (n=9)
Moderate: 8.2 (n=37) vs. 0.3 (n=11)
Severe: 14.8 (n=27) vs. 7.5 (n=8)
IIEF-Q3: 1.5 (0.2) vs. 0.2 (0.3)
IIEF-Q4: 2.0 (0.2) vs. 0.8 (0.3)
IIEF-IS: 4.8 (0.3) vs. 2.3 (0.7)
IIEF-OS: 3.6 (0.3) vs. 1.1 (0.6)
SEP-2, %: 34.5 (4.1) vs. –4.6 (8.1)
SEP-3, %: 52.2 (3.8) vs. 16.8 (7.8)
GAQ-1, %: 81.2 vs. 41.9
GAQ-2, %: 76.2 vs. 41.9
Other outcomes assessed: SEP Q4-5
Withdrawals/drop-outs/loss to f/u, n
(%): 17 (16.8) vs. 6 (19.4)
WDAE, n (%): 4 (3.9) vs. 0
TAE, n (%): NR
Most commonly reported, %: Headache
16.8 vs. 9.7; back pain 6.9 vs. 0;
dyspepsia 2 vs. 6.5
SAE, n (%): 1 (1) vs. 0 (death cardiac
arrest in a pts with multiple diseases)
Ascertainment of outcomes
assessed: IIEF, SEP, GAQ