Beste apotheek van Nederland

C-144
Author
Funding
N; study design; eligibility
Participants
characteristics
Diagnosis details Intervention Outcomes
Porst (2007) 154
Funding
source: NR
N screened = NR
N randomized = 131 (cross
over)
IG1, IG2 n = 131 (1:1 to
either arms: IG1sildenafil
then apomorphine n=68 vs.
IG2 apomorphine then
sildenafil, n=63)
CG: NA
ITT analysis used for
primary outcome: yes
(n=116)
Inclusion: men with ED,
IIEF-5 of 21 or lower, in
stable relationship
Exclusion: hypersensitivity
or any components of study
medication or to opiates,
major genital deformities
leading to difficulties in
performing intercourse,
serious CV conditions, ED tx
known to induce side
effects, alcohol or drug
abuse within last 30 d also
excluded
Age, mean (sd):
53 (12) y, range
22-77 y
Race: White 98%
Black 1%; other
1%
Co-morbidities, n
(%): hypertension
27.9%; DM 9.3%;
dyslipidemia 7%;
CAD 4.6%;
Previous ED
treatment: NR
Smoking status:
NR
Body weight: 85
(11.7) kg
Concomitant
medications, n (%):
NR
Duration of ED,
mean (range): 4.2
(0.2-30.6) vs. 3.5
(0.1-13.8) y
Underlying
disease, n (%): NR
Psychogenic ED, n
(%): 18 (26.5) vs.
23 (37.7)
Physiologic ED, n
(%): 19 (27.9) vs. 17
(27.9)
Mixed ED, n (%): 31
(45.6) vs. 21 (34.4)
IG1: Sildenafil
IG2: Apomorphine
IG1:
Dose: initial 50 mg
(adjusted to 25-100
based on efficacy and
tolerability after 4 wks;
55% titrated up and 5%
titrated down)
Duration: 8 wks
Frequency: on demand
Compliance: see
dropouts
IG2:
Dose: initial 2 mg
(adjusted to 2-3 afer 4
wks; 88% of pts titrated
up)
Duration: 8 wks
Frequency: as IG
Compliance: as IG
Run In period: 2 wks
Wash out period: 2
wks
F/u duration: f/u
measures at end of
each 8 wks tx period
Primary outcome results:
IIEF, mean sum score:
EF: 23.6 vs. 12.8, P<0.0001
IS: 12 vs. 9.2, P<0.0001
OS: 8.2 vs. 5.7, P<0.0001
Individual IIEF questions mean
difference from baseline (sd):
Q2: 1.9 (1.5) vs. 0.6 (1.3)
Q3: 1.8 (1.5) vs. 0.7 (1.2)
Q4: 1.8 (1.6) vs. 0.6 (1.2)
Successful intercourse attempts: 62.7%
vs. 28.3%
GEQ, % improved: 88.7% vs. 43.1%
Other outcomes assessed: adjusted
mean tx difference between grps
Withdrawals/drop-outs/loss to f/u, n
(%): 11 (8.4) did not complete the
study; 15 (11) excluded from analysis; 8
completed one phase
WDAE, n (%): 1 (0.8)
TAE, n: 65 vs. 35; pts with AE= 45
(35.7) vs. 27 (21.8) most common were
headache, flushing, dyspepsia and
rhinitis vs. headache and nausea
SAE, n (%): 2 (1.6) vs. 1 (0.8); including
1 death
Ascertainment of outcomes
assessed: IIEF, EDITS and GEQ, Q1
and Q2