Beste apotheek van Nederland

C-85
Author
Funding
N; study design; eligibility
Participants
characteristics
Diagnosis details Intervention Outcomes
Edwards (2006)
88
Funding
source: NR
N screened = 288
N randomized = 260
IG, n = 194
CG, n = 66
ITT analysis used for
primary outcome: yes
(LOCF; n=254)
Inclusion: men 18 or older
with ED for at least 6 mo; no
prior hx of PDE5i use
Exclusion: unstable
medical, psychiatric
condition; substance abuse;
hypoactive SD; SCI, surgical
prostatectomy; hereditary
degenerative retinal dx;
hepatitis B surface angina,
hepatitis C, HIV; liver
disease; sign hematologic
disease; active peptic
ulceration; any
cardiovascular condition; MI,
stroke, serious arrhythmia
within 6 mo of entry;
uncontrolled
hypo/hypertension; hx of
malignancy within 5 y; use of
nitrates or nitric oxide
donors; androgens or any
other investigational drug
Age, mean: 53.6 Concomitant
vs. 54.2
medications, n (%):
NR
Race: NR
Duration of ED: 2 y
Co-morbidities,
%: DM 27; Underlying
hypertension 35; disease, n (%): NR
Hyperlipidemia 10
vs. 6
Psychogenic ED,
%: 16 vs. 23
Previous ED
treatment: Physiologic ED, %:
29 vs. 24
Smoking status:
NR
Mixed ED, %: 55 vs.
53
Body weight: NR
Other:
Other: BMI, mean Baseline IIEF score:
27.4 kg/m 2 13.6
Severity of ED, %:
Severe 29% vs. 39%
IG: Vardenafil
CG: Placebo
IG:
Dose: flexible dose
starting dose of 10 mg
for 4 wks; adjusted to 5
or 20 mg for the next 8
wks
Duration: 12 wks
Frequency: NR
Compliance: 99%
CG:
Dose: NA
Duration: 12 wks
Frequency: NR
Compliance: 100%
Run In period: 4 wks
Wash out period: NA
F/u duration: 12 wks
(excluding the 4 wks
run-in period)
Primary outcome results:
IIEF-EF, mean: baseline moderate; post
tx 23.5 vs. 15.8; increase on score of
8.8 in IG vs. CG (95% CI 6.4, 11.1;
p<0.0001)
SEP-2, %: baseline 48 vs. 46
12 wks: 85 vs. 65
SEP-3, %: Baseline: 21 vs. 22
12 wks: 78 vs. 49
GAQ, % improved: 83% vs. 38%,
p<0.0001
Other outcomes assessed: TSS, sign
better score in IG vs. CG, p<0.0001
Withdrawals/drop-outs/loss to f/u, n
(%): 12 (6.7) vs. 4 (6.1)
WDAE, n (%): 3 (1.5) vs. 1 (1.5); IG
included MI, aortic bifurcation graft; CG
muscle cramp
TAE, n (%): NR; tx related occurring in
2% or more of pts, %: headache 5.2 vs.
0; flushing 7.3 vs. 0; Influenza 1 vs. 3
SAE, n (%): 2 (1.0) vs. 0; aortic
bifurcation graft and MI (MI occurred5 d
after last dose of 10 mg); no death
occurred
Outcome ascertainment: SEP- 2, 3;
GAQ; IIEF-EF; Treatment Satisfaction
Scale (TSS)