Beste apotheek van Nederland

C-107
Author
Funding
N; study design; eligibility
Participants
characteristics
Diagnosis details Intervention Outcomes
Carson (2005)
118
Funding
source: Lilly
ICOS LLC
N screened = 241
N randomized = 195
IG, n = 146
CG, n = 49
ITT analysis used for
primary outcome: Yes
Inclusion: men 18 or older,
with ED of at least 3-mo
duration; in stable
heterosexual relationship
Exclusion: serious CV
condition (e.g. MI, unstable
angina, sign.ECG
conduction deficit) within 90
days before screening;
nitrate tx; congestive heart
failure of New York Heart
Association Class 2 or
above; stroke in previous 6
mo; SBP >100 mm Hg or
<90 mm Hg; DBP >100 mm
Hg or <50 mm Hg; hx of
radical prostatectomy or
other pelvic surgery with
subsequent failure to
achieve an erection; prior
ineffective txt with sildenafil
Age, mean (sd):
60 (11) vs. 60 (10)
Race (%):
White: 119 (82)
vs. 43 (88);
African descent:
23 (16) vs. 6 (12);
Hispanic: 3 (2) vs.
0; Asian: 1 (0.7)
vs.0
Co-morbidities, n
(%):
Coronary artery
disease: 15 (10)
vs. 0; DM 32 (22)
vs. 8 (16);
Hyperlipidemia:
I52 (36) vs. 19
(39);
Hypertension: 59
(40) vs. 21 (43);
Prostatic cancer:
17 (11) vs. 4 (8)
Previous ED
treatment: NR
Smoking status:
24 (16.) vs. 8 (16.)
Body weight: NR
Concomitant
medications:
More than one: 126
(86) vs. 40 (82);
none 20 (14) vs. 9
(18)
Duration of ED,
range: 025 or less-
1 y or more [≥0.25 to
<0.5 y: 3 (2) vs. 0
≥0.5 to <1.0 y: 11 (8)
vs. 2 (4);
≥1 y: 132 (90) vs. 47
(96)
Underlying
disease: NR
Psychogenic ED, n
(%): 4 (3) vs. 2 (4)
Physiologic ED, n
(%): 119 (82) vs. 41
(84)
Mixed ED, n (%): 23
(16) vs. 6 (12)
IG: tadalafil orally
CG: placebo orally
IG1:
Dose: 20 mg
Duration: 12 wk
Frequency: 1 dose
before sexual activity;
max. 1/d
Compliance: NR
CG:
Dose: placebo
Duration: 12 wk
Frequency: 1 dose
before sexual activity;
max. 1/d
Compliance: NR
Run In period: 4 wk
Wash out period: NA
F/u duration: 12 wk
Primary outcome results:
IG vs. CG, mean change (SE)
IIEF EF: 7 (0.8) vs. –0.2 (1), p<0.001
IIEF –Q3 (ability to penetrate): 1 (0.2)
vs. 0.1 (0.3), p <0.001
IIEF-Q4 (maintaining erection): 1 (0.2)
vs. 0 (0.2), p < 0.001
Intercourse satisfaction: 3 (0.3) vs. –0.2
(0.5), p <0.001
OS: 2 (0.3) vs. –0.3 (0.3), p<0.001
SEP- Q2 ability to penetrate (% yes): 26
(3) vs. 2 (4.2), p<0.001
SEP-Q3 OS (% yes): 34 (3) vs. 5 (4),
p<0.001
Other outcomes assessed: partner
SEP2 and 3
Withdrawals/drop-outs/loss to f/u: 48
(IG1 30 [20.5%], CG 18 [36.7%])
WDAE, n: 9 (5.5% vs. 2%)
TAE: NR (AEs included headache in
9%, dyspepsia 5%, myalgia 3%;
reported mild or moderate in 90% of
cases)
SAE: 4; 3 (2%, carotid artery bruit,
esophageal spasm, brain neoplasm) vs.
1 (2%, angina pectoris)
Ascertainment of outcomes
assessed: IIEF- SEP; GAQ