Beste apotheek van Nederland

C-83
C2-Oral Vardenafil
Author
Funding
N; study design; eligibility
Participants
characteristics
Diagnosis details Intervention Outcomes
Carson (2004) 85
86
Companion
Hatzichristou
(2005) 86
Funding
source: Bayer
Corporation and
GlaxoSmithKline
N screened = NR
N randomized = 463
IG, n = 233
CG, n = 230
ITT analysis used for
primary outcome: yes (N
=454, n = 229 vs. n = 225)
Inclusion: men 18 or older
with ED, no response to 100
mg sildenafil indicated by at
least 4/ 6 unsuccessful
intercourse attempts; in
heterosexual relationship for
past 6 mo
Exclusion: 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,
itraconazole, ketokonazole,
erythromycin (more in full
text)
Age, mean
(range):
60 (29-83) vs. 59
(23-88) y
Race, n (%):
White: 404 (87);
Asian: 18 (10);
Hispanic: 14 (3);
Black: 13 (3);
Other: 5 (1)
Co-morbidities:
NR
Previous ED
treatment:
Sildenafil up to
100 mg
BMI, mean (sd):
29 (4) vs. 28 (4)
kg/m 2
Body weigh: NR
Other: Severity of
ED,
Severe: 242 (52);
moderate 164
(36); mild to
moderate 9 (2);
mild 8 (2)
IIEF-EF domain=
9.3 vs. 9.7
Concomitant
medications: NR
Duration of ED,
mean (sd): 5 (4) y
Underlying
disease, n (%):
Hypertension 90
(39) vs. 92 (41)
DM 78 (34) vs. 7
(25); Benign
prostatic
hyperplasia: 39 (17)
vs. 40 (18); CAD 8
(3) vs. 11 (5)
Psychogenic ED, n
(%): 8 (3) vs. 20 (9)
Physiologic ED, n
(%): 148 (65) vs.
128 (57)
Mixed ED, n (%): 3
(32% vs. 77 (34)
IG: vardenafil
CG: Placebo
IG:
Dose: 10 mg (option to
titrated to 5 or 20 mg at
4 and 8 wks)
Duration: 12 wks
Frequency: max 1/d
Compliance: 99% [n=2
(<1%) did not complete]
CG:
Dose: NA
Duration: 12 wks
Frequency: as IG
Compliance: 98%; [n=4
(2%) did not complete]
Run In period: NR
Wash out period: 24
hrs
F/u duration: 12 wks +
24 hrs post final visit.
Note: topical formulas
were allowed in this
study; investigational
drugs within 30 days of
screening therapy for
ED within 7 d or
vardenafil at any time
prior to study.
Primary outcome results:
IIEF-EF: baseline=<10 (severe ED);
post tx pts with normal scores, n
(%)=67 (31) vs. 12 (6)
SEP- Q2, % yes, n (%):
0.25 hr post dosing= 57 (62) vs. 55 (30)
>6 hr post dosing= 30 (77) vs. 18 (50)
SEP-Q3, % yes, n (%):
0.25 hr post dosing= 57 (53) vs. 55 (12)
>6 hr post dosing=30 (70) vs. 17 (24)
GAQ, % yes: 61.6% vs. 15% 61.8% vs.
14.7% at LOCF, p<0.001)
Other outcomes assessed:
intercourse attempts data
Withdrawals/drop-outs/loss to f/u, n
(%): 25 (11) vs. 41 (18); including
insufficient tx effect in 5 (2) vs. 17 (7)
WDAE, n (%): 5 (2) vs. 3 (2)
TAE, n (%): 40.7% vs. 22.6%; drug
related in 2% or more=flushing 16 (7)
vs. 2 (1); headache: 15 (6) vs. 4 (2);
nasal congestion: 11 (5) vs. 1 (<1);
dyspepsia: 8 (3) vs. 0; total mild AE= 55
(24) vs. 20 (9); total moderate AE= 34
(15) vs. 25 (11)
SAE, n (%): 7 (3.0) vs. 3 (0.9)
Outcome ascertainment: IIEF-EF;
SEP, Q2 and 3; GAQ