Beste apotheek van Nederland

C-130
Author
Funding
N; study design; eligibility
Participants
characteristics
Diagnosis details Intervention Outcomes
Skoumal (2004)
141
Funding
source: Eli Lilly
and Company
N screened = NR
N randomized = 409
IG1, n = 305
CG, n = 104
ITT analysis used for
primary outcome: Yes
Inclusion: men 18 or older,
with at least 3-mo hx of mild
to severe ED; same female
partner throughout study
Exclusion: ED due to
premature ejaculation or
untreated endocrine dx;
failure to achieve erection
after pelvic surgery,
including radical
prostatectomy (except
bilateral nerve-sparing); sign
penile deformity or penile
implant; clinically sign renal
or hepatic insufficiency;
poorly controlled diabetes;
unstable CA dx; recent hx of
sign CNS injury; hx of HIV
infection; exclusion of pts
with prior ineffective tx with
sildenafil was at discretion of
investigators
Age, mean (95%
confidence
interval): 52 (51­
53) vs. 52 (49-54)
y
Race (%): NR
Co-morbidities, n
(%): hypertension
98 (32) vs. 31
(30); Diabetes 43
(14) vs. 9 (9);
Prostatic
hyperplasia/
hypertrophy 19 (6)
vs. 11 (11);
hypercholesterole
mia 31 (10) vs. 9
(9);
hyperlipidemia: 16
(5) vs. 3 (3)
Previous ED
treatment: NR
Smoking status:
NR
Body weight: NR
Concomitant
medications: NR
Duration of ED:
less than 0.25 y -
equal or more than 1
y (majority, 78 vs.
80% with 1 y or
longer)
Underlying
disease: NR
Psychogenic ED, n
(%): 46 (15) vs. 19
(18)
Physiologic ED, n
(%): 89 (29) vs. 29
(28)
Mixed ED, n (%):
170 (56) vs. 56 (54)
Other: baseline IIEF
EF severity class, n
(%)= mild 145 (48)
vs. 49 (47);
moderate 89 (29) vs.
31 (30); severe 71
(23) vs. 24 (23)
IG1: Tadalafil (Cialis (R) )
oral
CG: placebo- oral
IG1:
Dose: 20 mg
Duration: 12 wk
Frequency: as needed
(max. 1/day)
Compliance (%): NR
CG:
Dose: placebo
Duration: 12 wk
Frequency: as needed
(max. 1/day)
Compliance (%): NR
Run In period: 4 wk
Wash out period: NA
F/u duration: 12 wk
Primary outcome results:
Mean change in IIEF score (and 95%
confidence interval)
EF: 10 (9-10.6) vs.1.4 (0.1-2.8)
Intercourse satisfaction: 5 (4.4-5.1) vs.
1.4 (0.8-2.1)
OF: 2 (1.9-2.6) vs. 0.2 (−0.4-0.8)
SD: 1 (0.9-1.3) vs. 0 (−0.3-0.4)
OS: 4 (3.4-4.0) vs. 0.7 (0.2-1.2)
Mean absolute change SEP-Q2 (yes):
approx. 2% vs. 35%
SEP-Q3: IG1 approx. 53%, CG approx.
13%
GAQ-1: 86% vs. 33%
GAQ-2: 97% vs. 94%
Other outcomes assessed: ED
Inventory of Treatment Satisfaction
scores
Withdrawals/drop-outs/loss to f/u, n
(%): 23 (6)
WDAE: 1 vs. 0
TAE, n (%): >/= 2 events= 55 (18) vs. 3
(3); headache, back pain in 10 vs. 3%;
flushing, influenza, and nasal
congestion only in IG (9%)
SAE: 2 (pulmonary embolism,
subarachnoid hemorrhage) vs. 0
Ascertainment of outcomes
assessed: IIEF ED domain, SEP (Q2,
and 3); GAQ