Beste apotheek van Nederland

C-125
Author
Funding
N; study design; eligibility
Participants
characteristics
Diagnosis details Intervention Outcomes
Rosano (2005)
136
Funding
source: Pfizer
N screened = 49
N randomized = 32
(Parallel double-blinded)
IG, n = 16
CG, n = 16
ITT analysis used for
primary outcome: NR
Inclusion: men aged 59-71
y, with presence of more
than 2 risk factors for
coronary artery dx (CAD)
regardless the degree of
their ED;
Exclusion: clinically sign
findings on physical exam or
presence of know clinically
sign dx that would prejudice
the completion of the study
or contraindicate tadalafil
assumptions; Recent acute
MI, primary valvular,
congenital heart dx;
myocardial, pericardial or
endocardial dx; congestive
heart failure
Age, mean (sd):
65 (6) y
Race: NR
Co-morbidities:
NR
Blood glucose,
mean (sd): sub
grp (n=8) with
type 2 diabetes 7
(0.5) HbA1C
Previous ED
treatment: NR
BMI (kg/m 2 );
mean (sd): 25.4
(3.2)
Smoking status,
n (%): 10 (31)
Body weight: NR
Concomitant
medications:
NR
Duration of ED: NR
Underlying
disease, n (%):
Diabetes: 8 (25)
Hypertension: 9 (28)
Psychogenic ED:
NR
Physiologic ED:
NR
Mixed ED: NR
Other: only 16
(50%) had presence
of ED
IG: Tadalafil (TAD)
CG: Placebo
IG1:
Dose: 20mg
Duration: 4 wks
Frequency: every other
d
Compliance: 100%
CG:
Dose:
Duration: 4 wks
Frequency: every other
d
Compliance: 100%
Run In period: 4wks
Wash out period:
None
F/u duration: Baseline,
end of each treatment,
2 wks after last tx
Primary outcome results:
IG vs. CG, mean (sd)
GAQ, (yes %) in IG, n=9; CG, n = 7: 8
(88) vs. 1 (14)
Brachial artery diameter, baseline to 4
and 6 wks: basal-1, basal 2,
nitroglycerine & hyperemia (mm): no
sign change from baseline in either grps
FMD, %: (sign▲ from baseline in IG
only)= 4 (0.6) to 9 (0.3) vs. 4 (0.6) to 4
(0.9)
Other outcomes assessed:
endothelial marker, mean (sd):
Serum nitrogen oxides 38 (12) to 53
(12) vs.36.5 (12) to 39 (8) µmol/l;
endothelin-1: sign ▼ from baseline ­
12% vs. 20% p/ml
Nitrite levels, (sign ▲ from baseline in
IG only) 38% vs. 7%
Withdrawals/drop-outs/loss to f/u:
None
WDAE: None
TAE, n (%): IG, 2 (12) Dyspepsia,
headache, back pain, pain, myalgia,
spontaneous erection nasal congestion
and infection
SAE: None
Ascertainment of outcomes
assessed: GAQ