Beste apotheek van Nederland

C-131
Author
Funding
N; study design; eligibility
Participants
characteristics
Diagnosis details Intervention Outcomes
Staab (2004) 142
Funding
source: Eli Lilly
and Company
N screened = NR
N randomized = 212
IG, n = 171 (2 mg =42, 5
mg= 44, 10 mg= 42, 25 mg
=43)
CG, n= 41
ITT analysis used for
primary outcome: NR
Inclusion: men18 or older;
with ED for 3 mo or longer;
in stable, monogamous,
heterosexual relationship
Exclusion: ED due to
untreated endocrine
disorder; hx of radical
prostatectomy, with failure to
achieve any erection; pelvic
surgery; sign penile
curvature; prior unsuccessful
tx with phosphodiesterase
type 5 inhibitors; hx of
human immunodeficiency
virus infection; poorly
controlled diabetes; clinically
sign hepatic, renal,
cardiovascular or central
nervous system dx during
prior 6 mo
Age, mean (sd):
58 (10) y
Race, n (%):
White 194 (92),
African descent 10
(5), Asian 7 (3),
other 1 (0.5)
Co-morbidities, n
(%): currently
active
cardiovascular
condition 85 (40),
hx of
cardiovascular
condition 8 (4),
diabetes 44 (21)
Previous ED
treatment: NR
Smoking status,
n (%): Current
smoker 40 (19)
Body weight,
mean (sd): 87
(14.5) kg
Concomitant
medications: NR
Duration of ED: NR
Underlying
disease: NR
Psychogenic ED:
NR
Physiologic ED:
NR
Mixed ED: NR
Other: ED severity:
mild 93 (44%);
moderate 52 (25%);
severe 67 (31%); no
sign difference
between IG
IG1: tadalafil -oral
CG: placebo -oral
IG1:
Dose: 2, 5, 10 or 25 mg
Duration: 8 wk
Frequency: max. 1/day
(1 dose before sexual
intercourse)
Compliance: NR
CG:
Dose: placebo
Duration: 8 wk
Frequency: as IG
Compliance: NR
Run In period: 4 wk
Wash out period: NA
F/u duration: 8 wk
Primary outcome results:
IG (only reported for 25 mg grp) vs. CG:
IIEF Q3, approximate % with score of 5:
75% vs. 20%
IIEF Q4, approximate % with score of 5:
62% vs. 10%
IIEF EF, mean score: 24 vs. 14
SEP Q3 - % positive response: 82% vs.
52%
SEP Q4 - % positive response: 78% vs.
40%
Other outcomes assessed: NA
Withdrawals/drop-outs/loss to f/u, n:
10
WDAE, n: 2
TAE: NR
SAE: NR
Ascertainment of outcomes
assessed: IIEF questions 3 and 4:
scored from 0 (no intercourse) to 5
(best performance) IIEF EF domain:
sum of scores for questions 1-5 and 15
Other: results are shown in probability
tables