Beste apotheek van Nederland

C-105
C3-Oral Tadalafil
Author
Funding
N; study design; eligibility
Participants
characteristics
Diagnosis details Intervention Outcomes
Aversa (2007)
116
Funding
source: NR
N screened = NR
N randomized = 20 (22
eligible at level II screening)
IG1/IG2, n = 20
CG, n = NA
ITT analysis used for
primary outcome: yes
Inclusion: men 18 y or older
with at least 3 mo hx of ED
of any severity or etiology
Exclusion: tx with nitrates,
cancer chemotherapy or
anti-androgens; CHF; hyperhomocysteinemia
or other
conditions or drugs impairing
endothelium-dependent
vaso-relaxation; (pts with
past use of commercially
available PDE-5i; and
concurrent active drugs
were not excluded)
Data reported for organic vs.
relational vs. Psychogenic
pts
Age, mean (sd):
54 (8) y
Race: NR
Co-morbidities, n
(%): hypercholesterolemia
6
(30); DM type II 4
(20); hypertension
4 (20); smoking 4
(20); Psychogenic
2 (10)
Previous ED
treatment: NR
Smoking status,
n (%): smokers 4
(20)
Body weight: NR
Other: BMI, mean
(sd) 25.4 (3.6)
kg/m 2
Concomitant
medications, n (%):
NR
Duration of ED: NR
Underlying
disease, n (%): see
co-morbidities
Psychogenic ED, n
(%): 2 (10)
Physiologic ED, n
(%): 18 (90)
Mixed ED, n (%):
NR
Other: semi
structured interview
for erectile
dysfunction (SIEDY)
score, median
(quirtile)= organic
3.93 (0-9); relational
2.53 (0-9);
Psychogenic 3.33
(0-5)
IG1: Tadalafil on
dememand (OD)
IG2: Tadalafil on
schedule alternated
days (AD)
IG1:
Dose: 20 mg
Duration:
Frequency: 4 wks
Compliance:
IG2:
Dose: 20 mg
Duration: 4 wks
Frequency: OD
Compliance:
Run In period: 4 wks
Wash out period: 2
wks
F/u duration: 6 time
point measurements at
baseline and end of
each tx period, and 2
wks after last dosing;
SIEDY not measured at
end point
Primary outcome results:
Sexual intercourse/mo: 5.9 (0.4) vs. 6.0
(0.7)
N of pills/ mo: 6.0 (1.9) vs. 15.2 (0.6),
p<0.05
PSV (cm/s):
Baseline: 9.3 (0.3) vs. 9.5 (0.4)
Post tx: 10.4 (0.9) vs. 13.2 (0.1)
FMD, %, mean (sd)
Baseline: 3.3 (0.6) vs. 1.2 (0.6)
Post tx: 2.1 (0.9) vs. 8.3 (0.3)
Systolic pressure (variation in mmHg):
-6.1 (2.2) vs. -4.0 (1.3)
Diastolic pressure (variation in mmHg):
-3.3 (1.3) vs. -2.3 (1.2)
Other outcomes assessed:
endothelial markers (VCAM; ICAM; ET­
1; CRP; insulin); insulin levels ▲ sign in
OD (IG1) compare to IG2
Withdrawals/drop-outs/loss to f/u, n
(%): NR
WDAE, n (%): 0
TAE, n (%): 2 (10); headache, back
pain, pain and myalgia (no report of
abnormal vision or priapism)
SAE, n (%): 0
Ascertainment of outcomes
assessed: blood flow measures by
laboratory analysis; sexual measures by
pts logs/interviews