Beste apotheek van Nederland

C-106
Author
Funding
N; study design; eligibility
Participants
characteristics
Diagnosis details Intervention Outcomes
Carrier (2005)
117
Funding
source: NR
(conflict of
interest reported
as Eli Lilly, or
ICOS CO
employed some
investigators)
N screened = 283
N randomized = 253
IG1, n = 103
IG2, n = 100
CG, n = 50
ITT analysis used for
primary outcome: yes,
Inclusion: men 18 or older,
with at least a 3 mo hx of ED
(organic, psychogenic or
mix) in a monogamous
relationship, and no ED tx
for at least 4 wk prior to
randomization
Exclusion: hx of radical
prostatectomy or other
pelvic surgery with
subsequent failure to
achieve erections, presence
of clinically sign penile
deformity, renal
insufficiency, angina,
unstable angina in last 6 mo,
hx of MI, coronary artery
bypass graft surgery or
precutaneous coronary
intervention within 90 d, HIV,
current tx with nitrates,
cancer chemotherapy or
antiandrogens, or prior nonresponse
to tx with sildenafil
Age, mean (sd):
59 (9) vs. 58 (11)
vs. 59(10) y
Race: 95%
Caucasian
Co-morbidities,
(%): hypertension
23 vs. 32 vs. 18,
arthritis 23 vs. 24
vs. 20; DM 23 vs.
24 vs. 16; allergic
reaction 22 vs. 13
vs. 16; prostate dx
19 vs. 16 vs. 26;
hypercholesteremi
a 13 vs. 18 vs. 8;
hyperlipidemia 11
vs. 8 vs. 12, back
pain 12 vs. 12 vs.
4, hernia 6 vs. 7
vs. 12; headache
7 vs. 5 vs. 10;
pain 11 vs. 8 vs.
10
Previous ED
treatment, %:
sildenafil 68 vs. 54
vs. 62
Smoking status,
%: 12 vs. 21 vs.
22
Body weight,
mean (sd): 90
(15) vs. 88(10) vs.
84 (12) kg
Concomitant
medications: for
hypertension CAD,
cardiac arrhythmias,
congestive heart
failure,
hyperlipidemia, and
DM, n (%)= 101 (98)
vs. 28 (56) vs. 62
(62)
Note: list of
medications is
provided in the full
text article
Duration of ED, n
(%): 1 yr or more=
92 (92) vs. 92 (89)
vs. 45 (90)
Underlying
disease, %:
prostatic disorder 19
vs. 16 vs. 26
Psychogenic ED:
NR
Physiologic ED:
most commonly
present
Mixed ED: NR
IG1: Tadalafil
IG2: Tadalafil
CG: placebo
IG1:
Dose: 20 mg
Duration: 12 wks (three
4 wk periods,
Frequency: once /d
Compliance: NR
IG2:
Dose: 10 mg
Duration: 12 wks
Frequency: once/ d
Compliance: NR
CG:
Dose: NR
Duration: same as IG
Frequency: same as IG
Compliance: NR
Run In period: NR
Wash out period: NR
F/u duration: 12 wk
Primary outcome results:
Change in IG1 vs. IG2 vs. CG, mean
(SE)
IIEF EF domain (1-30): 8 (0.8) vs. 6.6
(0.8) vs. –0.9 (1.1)
IIEF intercourse satisfaction (0-15): 3.2
(0.3) vs. 2.2 (0.3) vs. 0.4 (0.4)
Successful penetration (SEP-Q2): 21.3
(3.6) vs. 21.3 (3.8) vs. –6.4 (4.1)
Successful intercourse (SEP-Q3): 29
(3.7) vs. 32.8 (3.7) vs. 4.9 (4.3)
End point Improved erection (GAQ), n
(%): 79 (79) vs. 69 (67) vs. 11 (22)
Other outcomes assessed: NA
Withdrawals/drop-outs/loss to f/u:
n=34 (4 vs. 14 vs. 6)
Note: pts without both baseline and
post-baseline data were excluded from
analysis, 3 vs. 4 vs. 1
WDAE: n=5 (IG1 n=3, IG2 n=2)
TAE, n (%): AE in >/= 5%= 94 (94) vs.
84 (82) vs. 31 (62) (% with dyspepsia:
22 vs. 10 vs. 2; headache: 17 vs. 15 vs.
8; infection: 11 vs. 19 vs. 22; pain: 8 vs.
10 vs. 2; back pain: 7 v. 5 vs. 2;
vasodilatation 6 vs. 4 vs. 4; flu
syndrome: 5 vs. 8 vs. 10; accidental
injury: 5 vs. 1 vs. 4; rhinitis: 4 vs. 6 vs.
4; myalgia 4 vs. 5 vs. 4
SAE: NR
Ascertainment of outcomes
assessed: IIEF; SEP Q2 & 3 and GAQ