Beste apotheek van Nederland

Author
Funding
N; study design; eligibility
Participants
characteristics
Diagnosis details Intervention Outcomes
Eardley (2004)
122
Funding
source: Lilly
ICOS LLC
N screened = 237
N randomized = 220
IG1 screened = NR
IG1 randomized = 168
IG2 screened = NA
IG2 randomized = NA
CG screened = NR
CG randomized = 52
Inclusion: age ≥18 yr; at
least 3-mo hx of mild to
severe ED; in stable
heterosexual relationship
Exclusion: hx of radical
prostatectomy (except for
bilateral nerve-sparing) or
other pelvic surgery, with
subsequent failure to
achieve erection; hx of
ineffective treatment with
sildenafil; unstable
cardiovascular disease (e.g.
unstable angina, recent
myocardial infarction or
stroke, poorly controlled
hypertension, and New York
Heart Association Class II
and above congestive heart
failure); evidence of clinically
sign. renal insufficiency or
hepatic insufficiency (e.g.
active symptomatic
hepatobiliary disease or
jaundice); treatment with
nitrates, antiandrogens or
chemotherapy
Age, mean (sd):
IG1 53.6 (range
26-78), CG 52.9
(range 29-73)
Race (%): White:
IG1 167 (99.4%),
CG 52 (100%)
Co-morbidities
(unrelated to
disease):
Hypertension: IG1
42 (25.0%), CG
10 (19.2%)
Diabetes: IG1 20
(11.9%), CG 5
(9.6%)
Alcohol user: IG1
82 (48.8%), CG
30 (57.7%)
Blood glucose
(or HbA1C)(%):
NR
Previous ED
treatment:
Sildenafil: IG1 81
(48.2%), CG 26
(50.0%)
BMI (kg/m 2 ): NR
Smoking status:
Smoker: IG1 39
(23.2%), CG 16
(30.8%)
Initial body
weight: IG1 84.5
kg (range 41-150),
CG 83.2 kg (range
60-118)
Concomitant
medications: NR
Duration of ED (yr):
0.25-0.5: IG1 15
(8.9%), CG 7
(13.5%)
0.5-1: IG1 14 (8.3),
CG 7 (13.5%)
≥1: IG1 139 (82.7%),
CG 38 (73.1%)
Underlying disease
(diagnosis) (N or %
of diseased/grp):
NR
Psychogenic ED:
IG1 30.4%, CG
26.9%
Physiologic ED:
IG1 37.5%, CG
32.7%
Mixed ED: IG1
32.1%, CG 40.4%
Other:
Mild ED: IG1 56
(33.3%), CG 16
(30.8%)
Moderate ED: IG1
41 (24.4%), CG 13
(25.0%)
Severe ED: IG1 68
(40.5%), CG 21
(40.4%)
C-111
IG1: tadalafil orally
IG2: NA
CG: placebo orally
IG1:
Dose: 20 mg
Duration: 12 wk
Frequency: as needed
(max 1/day)
Compliance (%): NR
IG2: NA
Dose:
Duration:
Frequency:
Compliance (%):
CG:
Dose: placebo
Duration: 12 wk
Frequency: as needed
(max 1/day)
Compliance (%): NR
Run In period: 4 wk
Wash out period: NA
F/u duration (both on
and off treatment): 12
wk
Other: No
Primary outcome results:
Change in EF domain of IIEF and in
positive response to questions 2 (“Were
you able to insert your penis into your
partner’s vagina?”) and 3 (“Did your
erection last long enough for you to
have successful intercourse?”) of
Sexual Encounter Profile (SEP) diary
Mean change in IIEF EF
IG1 11.1 (SD 27.2), CG 0.4 (SD 6.6)
Mean absolute change in positive
response to SEP
Q2: IG1 41.0%, CG 7.3%
Q3: IG1 56.5%, CG 10.8%
List (narrative) other outcomes
assessed: Change in other IIEF
domains; positive response to SEP
questions 4 and 5; positive response to
GAQ (“Has the treatment you have
been taking during this study improved
your erections?” and “If yes, has the
treatment improved your ability to
engage in sexual activity?”)
AE (in ≥2% of patients in IG1):
Headache: IG1 30 (17.9%), CG 3
(5.8%). Dyspepsia: IG1 22 (13.1%), CG
0. Flushing: IG1 8 (4.8%), CG 1 (1.9%).
Back pain: IG1 6 (3.6%), CG 0. Pain in
limb: IG1 6 (3.6%), CG 0. Myalgia: IG1
4 (2.4%), CG 1 (1.9%).
ITT analysis used for primary
outcome? Y
Withdrawals/drop-outs/loss to f/u [N
andor %]: 25 (IG1 16, CG 9)
WDAE (N and/or %): IG1 5 (3.0%), CG
1 (1.9%)
TAE: NR
SAE: IG1 3, CG 1; none judged to be
related to study drug
Ascertainment of outcomes
assessed: NA