Beste apotheek van Nederland

C-108
Author
Funding
N; study design; eligibility
Participants
characteristics
Diagnosis details Intervention Outcomes
Chen, KK (2004)
119
Funding
source: NR
N screened = 222
N randomized = 196
IG, n = 65
IG2, n = 65
CG, n = 66
ITT analysis used for
primary outcome: yes
Inclusion: men at least 21
yrs, in a monogamous
relationship, at least 3 mo hx
of ED of any origin
Exclusion: hx of radical
prostatectomy or other
pelvic surgery with
subsequent ED,
insufficiency in past 6 mo,
hepatobiliary dx, angina
occurring during sexual
intercourse in last 6 mo, hx
of MI, coronary artery
bypass graft surgery, or
percutaneous coronary
intervention within 90 d prior
to 1 st visit, hx of HIV
infection or current infection
with any sexually transmitted
dx, tx with nitrates, cancer
chemotherapy, or antiandrogens,
and prior no
response to tx with sildenafil
citrate
Age, mean (sd):
59 (11.8) vs. 60.4
(11.5) vs. 60.2
(12.9) yr
Race (%): NR
Co-morbidities, n
(%): prostatic dx
20 (31) vs. 25 (39)
vs. 25 (38)
hypertension 11
(17) vs. 22 (34)
vs. 19 (29); CAD
(NR);
hyperlipidemia 8
(12) vs. 5 (8) vs. 5
(8), and DM 11
(17) vs. 20 (31)
vs. 16 (25)
Previous ED
treatment, n (%):
sildenafil 29 (45)
vs. 39 (60) vs. 31
(47)
Smoking status,
n (%): 22 (34) vs.
24 (37) vs. 25 (38)
Body weight: NR
Concomitant
medications:
medication for
hypertension (20%
vs. 37% vs. 36%),
CAD; cardiac
arrhythmias;
congestive heart
failure;
hyperlipidemia; DM
(14% vs. 25% vs.
18%)
Duration of ED, n
(%): > 1yr 59 (91)
vs. 58 (89) vs. 61
(92)
Underlying
disease:
prostatic disorder;
hypertension (17%
vs. 34% vs. 29%);
DM (17) vs. 31% vs.
24%);
hyperlipidemia
Psychogenic ED
(%): 6 vs. 9 vs. 11
Physiologic ED
(%): 71 vs. 69 vs. 65
Mixed ED (%): 23
vs. 22 vs. 24
IG1: Tadalafil 10 mg
IG2: Tadalafil 20 mg
CG: Placebo
IG1:
Dose: 10 mg
Duration: 12 wks
Frequency: as needed,
max 1/d
Compliance: NR
IG2:
Dose: 20 mg
Duration: 12 wk
Frequency: as needed,
max 1/d
Compliance: NR
CG:
Dose: NR
Duration: 12 wk
Frequency: as needed,
max 1/d
Compliance: NR
Run In period: 4 wks
Wash out period: NA
F/u duration: 12 wks
Primary outcome results:
mean change in score from baseline;
overall p value in IG1 vs. IG2 vs. CG:
IIEF (1-30): 8 vs. 8 vs. 2.6; p<0.001
[IIEF (intercourse satisfaction domain):
sign. ▲ in IG1 and IG2 vs. placebo
% of pts with normal IIEF score at end
point: 42 vs. 63 vs. 20
SEP (Q2): 34 vs. 35, vs. 10; p<0.001
SEP (Q3): 48, vs. 50, vs. 15; p<0.001
GAQ, % of pts improved erections at
endpoint (%): 92 vs. 85 vs. 55 (p<0.001
for overall and pair wise comparison)
Other outcomes assessed: NA
Withdrawals/drop-outs/loss to f/u, n
(%): n=13 (7); 4 (6) vs. 3 (5) vs. 6 (9)
(personal, sponsor or physician
decision to withdraw, n=4 vs. 2 vs. 2)
WDAE, n (%): n=3 (1.5): IG2 1 (1.5)
elevated serum transaminases vs. CG 2
(3), deafness and MI
TAE, n (%): incidence in >/=5%= 37
(57) vs. 46 (71) vs. 29 (44); AE included
back pain, dyspepsia, myalgia,
infection, rhinitis, dizziness, headache,
▲ cough, arthritis, pharyngitis
SAE: NR
Ascertainment of outcomes
assessed: IIEF at 4, 8 and 12 wks;
SEP Q2 & 3 post each intercourse;
GAQ at final visit