Beste apotheek van Nederland

C-103
Author
Funding
N; study design; eligibility
Participants
characteristics
Diagnosis details Intervention Outcomes
van Ahlen
(2005) 114
Funding
source: NR(5/6
authors are
employees of
Galxo-
SmithKline/
Bayer producers
of vardenafil)
N screened = NR
N randomized = 388 (98
primary care sites in
Germany)
IG, n = 193 (ITT=178)
CG, n = 195 (ITT= 176)
ITT analysis used: yes (last
observation carried forward)
Inclusion: men 18 or older
with ED of 6 mo or longer;
arterial hypertension
controlled with 1 or more
medication; able to maintain
4 wk ED tx free (at least 4
intercourses)
Exclusion: prior use of
PED5 inhibitors; penile
anatomical abnormalities;
hypoactive SD; ED due to
SCI or radical
prostatectomy; retinitis
pigmentosa; hepatitis B, C
surface antigen or; unstable
angina pectoris; MI, stroke,
ischemia; DM; hypotension;
use of anticoagulants,
androgens, trazodone,
antiandrogens, alpha1
antagonist, potent HIV
protease inhibitor, nitrates,
ketokonazole, erythromycin
(more in full text)
Age, mean
(range):
IG1: mean 56
(range 22-78) y
Race (%): NR
Co-morbidities:
NR
Previous ED
treatment: NR
BMI, mean: 28 vs.
27 kg/m 2
Smoking status:
NR
Body weight,
mean (sd):
88 (14) vs. 86 (12)
kg
Concomitant
medications, n (%):
Antihypertensive
medications:
Diuretics: 24 (13) vs.
15 (8); Betablockers:
81 (42) vs.
82 (43); Calcium
channel blockers: 36
(19) vs. 28 (15);
Reninangiotensin
acting agents: 136
(71) vs. 133 (70)
Mean number of
antihypertensives
per patient: 1.5 vs.
1.4
Duration of ED (yr):
NR
Underlying
disease, (%):
Hypertension 100
vs. 99
Psychogenic ED:
NR
Physiologic ED:
NR
Mixed ED: NR
IG: Vardenafil
CG: placebo
IG:
Dose: starting 10 mg (5
mg in pts 65 or older)
one step titration to 5 or
20 mg at 4 & 8 wks
Duration: 12 wks
Frequency: 1/ d
Compliance: NR
CG:
Dose: NA
Duration: 12 wks
Frequency: 1/ d
Compliance: NR
Run In period: 4 wks tx
free
Wash out period: 4
wks ED tx free
F/u duration: 12 wks
(4, 8, and 12 wks
measures)
Other: Allowed a single
dose per day (No use
of nitrate or concurrent
ED therapy ≤ 7 d of
study or any
investigational drugs <
30 d prior to screening;
no use of alphablockers
permitted)
Primary outcome results:
SEP-Q2, % yes: 83 vs. 58, p< 0.0001
SEP- Q3, % yes: 67 vs. 35, p < 0.0001
IEEF-EF, mean score: baseline = 14
vs. 14.5; post tx= 25 vs. 18, p< 0.0001
(unaffected by the class of
antihypertensive used)
GAQ, % yes: 80 vs. 40, p < 0.0001
Other outcomes assessed:
association of tx with clinical measures
of BP, or HR
Withdrawals/drop-outs/loss to f/u: 34
(8.7)
WDAE, n (%): 4 (2) vs. 2 (1)
TAE, (%): 21.2% vs. 16.4%; including
headache: 6 (3) vs. 1 (0.5); flushing: 3
(2) vs. 1 (0.5)
SAE, n (%): 6 (3) vs. 2 (1); no detail
provided
Outcome ascertainment: IIEF-EF,
sum score of Q 1, 5 and 15, SEP
question 2 and 3; and GAQ