Beste apotheek van Nederland

C-89
Author
Funding
N; study design; eligibility
Participants
characteristics
Diagnosis details Intervention Outcomes
Hellstrom (2002)
94 95 96 97
Funding
source: Bayer
Pharmaceutical
& Bayer Inc.
N screened = 1311
N randomized = 805
(parallel grps)
IG1: n= 193
IG2: n = 199
IG3: n = 188
CG: n = 182
ITT analysis used for
primary outcome: Yes
(n=749; safety population:
n=762)
Inclusion: heterosexual
men 18 y or older with ED, >
6 mo in duration; also with
50% or more failure rate in
maintaining erection on at
least 4 intercourse attempts
on 4 separate d before tx
Exclusion: Ed due to SCI,
radical prostatectomy,
retinitis pigmentosa, angina
pectoris or poorly controlled
DM; primary hypoactive SD,
no response to sildenafil, hx
of hepatitis B or C, &
concomitant use of nitrates
Note: Data reported as IG1
vs. IG2 vs. IG3 vs. CG
Age, range:
57-78 y (mean
range per grp 57­
58 y)
Race, %:
Caucasian 77 vs.
80 vs. 82 vs. 77
Co-morbidities:
hypertension,
prostatic
hyperplasia,
diabetes type II,
depression, prior
MI,
hyperlipidemia,
obesity, all not
sign. between
grps
Previous ED
treatment
sildenafil (%): 77
vs. 74 vs. 66 vs.
68
BMI, mean: 29
kg/m 2
Smoking status:
NR
Body weight: NR
Concomitant
medications: NR
Duration of ED,
mean: 1 st
diagnosed: 3.6 vs.
3.6 vs. 4.2 vs. 2.9 y
(1 st noticed: 5.9 vs. 6
vs. 6.6 vs. 5.1 y)
Underlying
disease: NR
Psychogenic ED,
%: 7 vs. 7 vs. 7 vs. 9
Physiologic ED, %:
61 vs. 59 vs. 60 vs.
54
Mixed ED, %: 33 vs.
34 vs. 33 vs. 37
Other: baseline IIEF
score: 12.6 vs. 13.4
vs. 12.8 vs. 13.7
IG1-3: Vardenafil
CG: placebo
IG1-3:
Dose: IG1 = 5 mg; IG2
= 10 mg; IG3= 20 mg
Duration: 26 wks
Frequency: once/ d
Compliance (%): NR
CG:
Dose: NA
Duration: as IG
Frequency: as IG
Compliance (%): NR
Run In period: 4 wks
Wash out period: NA
F/u duration: 26 wks (1
wk post last tx)
Primary outcomes:
IIEF- mean score (LOCF), IG vs. CG:
EF, Baseline=14; post tx: 18-22 vs. 15
IS (Intercourse satisfaction): 10 vs. 8
OS: 7 vs. 5
SEP-Q2, % yes:
Baseline: 43 vs. 45 vs. 41 vs. 46
Post tx: 66 vs. 76 vs. 81.1 vs. 52
SEP-Q3:
Baseline=15;
Post tx: 52-67 vs. 33
GAQ, % yes: 65 vs. 80 vs. 85 vs. 28
Other outcomes assessed: self
reported erection hardness; satisfaction
with intercourse, and OS
Drop outs: n=297 (37%): 38% vs. 27%
vs. 30% vs. 54% (non compliance,
consent withdraw, insufficient tx effect,
protocol violation, & lost to F/u)
WDAE, n (%): 8 (4.1) vs. 7 (3.5) vs. 15
(7.9) vs. 4 (2.2) reasons reported only
for IG=headache, abnormal liver
function, nausea, and kidney calculus
TAE: NR; AEs included headache,
rhinitis, flushing, dyspepsia, accidental
injury; all numerically more frequent in
IG compare to CG
SAE (%): 5 vs. 3 vs. 4 vs. 5 (one MI, no
death)
Outcome ascertainment: IIEF, GAQ,
diaries, SEP, Q2 and 3