Beste apotheek van Nederland

C-141
Author
Funding
N; study design; eligibility
Participants
characteristics
Diagnosis details Intervention Outcomes
Lammers (2002)
151
Funding
source: NR
N screened = 68
N randomized = 43 (4 way
cross over)
IG1-4, n = 43
CG, n = NA
ITT analysis used for
primary outcome: NR
Inclusion: ED of > 6mo,
moderate to severe, in a
stable monogamous
heterosexual relationship,
provided informed consent,
informed partners of study
participation
Exclusion: ED caused by
untreated endocrine dx,
postural hypotension or
uncontrolled hypotension,
sign. penile pathology, hx of
sign. hepatic or renal dx,
CAD, nervous system dx,
radical prostatectomy,
uncontrolled psychiatric
condition, known intolerance
to study medications,
concomitant use of organic
nitrates, regular use of
sympathetic-CNS
depressors, blood donations
(pts with ▼of >30% SBP, or
DBP or ▲ of >30% HR after
in office drug administration
were withdrawn)
Age, range:
40-75 y
Race: NR
Co-morbidities:
NR
Previous ED
treatment: many
had used
sildenafil, (and
other study
medications)
Smoking status:
NR
Body weight: NR
Concomitant
medications: NR
Duration of ED
(mo): > 6 mo
Underlying
disease: NR
Psychogenic ED:
NR
Physiologic ED:
NR
Mixed ED: NR
IG1: phentolamine +
apomorphine
IG2: phentolamin +
papaverine
IG3: phentolamine +
papaverine +
apomorphine
IG4: sildenafil
IG1:
Dose: 40 mg + 6 mg
Duration: NA
Frequency: once (in
office)
IG2:
Dose: 40 mg +150 mg
Duration: NA
Frequency: as IG1
IG3: 40 mg+150 mg +6
mg
Duration: NA
Frequency: as IG1
IG4:
Dose: 100 mg (not
blinded)
Duration: NA
Frequency: as IG1
Compliance (all): 100%
Run In period: 4 wks
placebo
Wash out period: NA
F/u duration: 60 min
post tx
Primary outcome results:
SEP, mean ▲ from baseline:
1.9 vs. 1.6 vs. 1.7 vs. 1.8
Successful vaginal penetrations, mean
proportion:
Baseline: 0.13
Post tx: 0.5 vs. 0.4 vs. 0.5 vs. 0.4
GAQ (1-5), mean score: 2.9 vs. 2.9 vs.
2.9 vs. 2.5
Rigidity by VAS (baseline = 17): 45 vs.
44 vs. 45 vs. 46
Other outcomes assessed: Tx
preference, duration and satisfaction;
vaginal intercourse leading to orgasm
Withdrawals/drop-outs/loss to f/u: 1
WDAE: 0
TAE: 150 (in 19 pts) including CV
events 2 (5) in IG3, and 2 (5%) in IG4
Most frequent AEs: rhinitis 4 (10) vs. 2
(5) vs. 6 (15) vs. 3 (8); headache 2 (5)
vs. 1 (2) vs. 1(2) vs. 3 (8); dyspepsia 2
(5) only in IG3; nausea 2 (5) only in IG2
SAE: 1 hospitalization for right
nephrectomy, (grp NR)
Ascertainment of outcomes
assessed: SEP; visual analogue scale
of 0-100 (VAS), GAE, reports of AE