Beste apotheek van Nederland

C-123
Author
Funding
N; study design; eligibility
Participants
characteristics
Diagnosis details Intervention Outcomes
Rajfer (2006) 134
Funding
source: Lilly
ICOS LLS.
N screened = 314
N randomized = 287(15 US
Centres)
IG1, n = 96
IG2, n = 97
CG, n = 94
ITT analysis used for
primary outcome: yes
Inclusion: men 18 y or
older, with ED at least 3 mo
in duration caused by
psychological, organic or
mixed factors
Exclusion: ED due to
premature ejaculation or
untreated endocrine
disease, radical
prostatectomy or pelvic
surgery; penile implant or
penile deformity; clinically
sign renal or hepatic
insufficiency; unstable
angina; MI; coronary artery
intervention; hx of heart
problems; SBP > 170 or <90
mmHg, DBP >100 or <50
mmHg; hx of stroke, SCI;
HIV infection
Age, mean
(range): 60 (25.5­
82.3) y
Race: Caucasian
86%; Hispanic
5.6%; African
decent 5.6%;
Western Asian
1%; Other 1%
Co-morbidities, n
(%): CAD 30
(10.4); depression
22 (7.6); DM 40
(14); hyperlipidemia
64(22.3);
hypertension 123
(42.8)
Previous ED
treatment: NR
Smoking status:
NR
Body weight: NR
Other: ED
severity at
baseline, % by
IIEF: mild 35%;
moderate 26%;
sever 39%.
Concomitant
medications, n (%):
Duration of ED:
96.3% with ED of 12
mo or longer
Underlying
disease, n (%): NR
Psychogenic ED, n
(%): 5 (5) vs. 2 (2)
vs. 5 (5)
Physiologic ED, n
(%): 67 (70) vs. 67
(69) vs. 62 (66)
Mixed ED, n (%): 24
(25) vs. 28 (29) vs.
27 (29)
Other: baseline ED
defined as:
consistent change in
erection quality
adversely affecting
satisfaction with
sexual intercourse)
IG1:Tadalafil low dose
IG2:Tadalafil high dose
CG: placebo
IG1:
Dose: 2.5 mg
Duration: 24 wks
Frequency: once/d
Compliance: 94.8%*
IG2:
Dose: 5 mg
Duration: 24 wks
Frequency: once/d
Compliance: 94.8%*
CG:
Dose:
Duration: 24 wks
Frequency: once/d
Compliance: 94.8%*
Run In period: 4 wks
Wash out period:
F/u duration:
*Note: compliance met
if >70% of doses were
administered
Primary outcome results:
IIEF-EF, mean baseline: 13.4 (1-28)
all pts at 24 wks: 19.1 vs. 20.8 vs. 14.6
In mild ED: 24.3 vs. 26.2 vs. 20.8
In moderate ED: 21 vs. 21.9 vs. 14.3
In sever ED: 13.8 vs. 15.5 vs. 8.9
SEP-2, %:
All pts at 24 wks: 65.3 vs. 70.7 vs. 51.1
Mild ED: 90.0 vs. 91.9 vs. 79.9
Moderate ED: 74.8 vs. 82.2 vs. 55.7
Severe ED: 38.9 vs. 44.9 vs. 20.1
SEP-3, %:
All pts at 24 wks: 50.0 vs. 56.9 vs. 31.3
Mild ED: 72.5 vs. 82.2 vs. 56.7
Moderate ED: 56.3 vs. 61.3 vs. 27.3
Severe ED: 27.4 vs. 32.6 vs. 9.2
GAQ-1, % yes: 62.8 vs. 72.8 vs. 26.1
GAQ-2, % yes: 58.5 vs. 70.7 vs. 23.9
Other outcomes assessed: IIEF, IS
domain; IIEF Q3, 4
Withdrawals/drop-outs/loss to f/u, n
(%): 15 (15.6) vs. 16 (16.5) vs. 18(19)
WDAE, n (%): 6(6.3) vs. 4(4.1) vs.
2(2.1)
TAE, n (%): AE occurring in 3% or
more 40 (42) vs. 35 (36) vs. 22 (23)
SAE: pts with >/=1 SAE 2 vs. 3 vs. 2
including MI, fractures, an road traffic
accident
Ascertainment of outcomes
assessed: IIEF-EF; SEP-2, 3;GAQ;
PAIRS