Beste apotheek van Nederland

C-122
Author
Funding
N; study design; eligibility
Participants
characteristics
Diagnosis details Intervention Outcomes
Porst (2003) 133
Funding
source: Lilly
ICOS LLC
N screened = NR
N randomized = 348
IG, n = 175
CG, n = 173
ITT analysis used for
primary outcome: Y
Inclusion: men 18 or older,
minimum 3 mo ED (defined
as consistent change in the
quality of erection adversely
affecting the pts satisfaction
with intercourse), in a stable
monogamous relationship
Exclusion: penile implants
or clinically sign penile
deformities, failure to
achieve erection after radical
prostatectomy or pelvis
surgery, hx of stroke or
spinal cord trauma in the
past 6 mo, unstable cardiac
disease, and concomitant
antiandrogen use or
chemotherapy
Age, mean (sd):
57 (NR), range: IG
22-80, CG 28-87
yr
Race (%): White
93 vs. 95; African
8 vs. 2; Hispanic 4
vs. 7; other 1 vs. 0
Co-morbidities:
NR
Previous ED
treatment: NR
Smoking status:
current smoker
25% vs. 23
Body weight: NR
Other: alcohol
use 57% vs. 61%
Concomitant
medications: NR
Duration of ED (yr):
more than 1 y (in
majority of pts)
Underlying
disease: NR
Psychogenic ED,
%: 13 vs. 18
Physiologic ED, %:
45 vs. 53
Mixed ED, %: 42%
vs. 36%
Other: severity of
ED (IG vs. CG) mild
70% vs. 69%,
moderate 45% vs.
43%, severe 60%
vs. 61% (based on
erectile domain of
IIEF)
IG1: Tadalafil
CG: Placebo
IG1:
Dose: 4 x 20 mg
Duration: 8 wks (two 4
wk period, intercourse
24 hrs and 36 hrs after
each dose in 1st and
2nd period respectively)
Frequency: twice/ 4 wks
Compliance: 98%
CG:
Dose: placebo
Duration: same as IG
Frequency: same as IG
Compliance: 99.5%
Run In period:
Wash out period: 8-10
d between two doses in
each 4 wk period
F/u duration: 8 wks
Primary outcome results:
Successful intercourse attempts, n (%):
24 hr: 120/227 (53) vs. 72/247 (29.),
p<0.001
36 hr: 132/223 (59) vs. 60/212 (28),
p<0.001
Patients with successful intercourse
attempts, (%):
24 hr: 61 vs. 37, p<0.001
36 hr 64 vs. 35, p<0.001
Other outcomes assessed: NA
Withdrawals/drop-outs/loss to f/u:
n=21
WDAE, n (%): n=4, 3 (2) vs. 1 (0.5)
TAE, n (%): 89 vs. 2;
Headache 14 (8) vs. 2 (1), p=0.003,
Flushing 10 (6) vs. 0, p=0.002
Dyspepsia 59 (34) vs. 0, p=0.004
Myalgia 6 (3) vs. 0
SAE: 0
Ascertainment of outcomes
assessed: Pts self report on Sexual
Encounter Profile (SEP-Q3)