Beste apotheek van Nederland

C-155
Author
Funding
N; study design;
eligibility
Participants
characteristics
Diagnosis details Intervention Outcomes
Dinsmore (1999)
164
Funding source:
Senetek plc
IG screened = 236
IG randomized = 171
(parallel)
IG1/ CG, n= 107 (ITT)
IG2/ CG, n = 29 (ITT)
ITT analysis used for
primary outcome: Yes
(per protocol analysis also
reported)
Inclusion: en 18 y or
older, with ED of 1 y or
longer in duration in stable
heterosexual relationship
Exclusion: overt
psychogenic aetiology,
ability to perform
intercourse without
medication or physical aid,
hypoactive sexual dx,
nocturnal or early morning
erections, systemic dx,
sickle-cell trait or dx;
surgery, hormonal
imbalance requiring
treatment (except
diabetes mellitus), angina
pectoris, uncompensated
congestive heart failure,
hx of drug abuse (other
exclusion lists could be
found in the article)
Note: Dose assessment
phase: vasoactive
intestinal polypeptide
given by auto injector IC
Age, mean
(range):
56.5 (25-81) y
Co-morbidities:
NR
Previous ED
treatment (n):
IC PgE-1 n=96;
papaverine/PM
n=64; Other
(yohimbine,
vacuum devices)
n=19
Smoking status:
NR
Body weight: NR
Concomitant
medications: NR
Duration of ED (yr):
NR
Underlying
disease: NR
Psychogenic ED:
NR
Physiologic ED
(%): 61%
(arteriogenic 16%;
DM 16%;
neurogenic 16%;
venous leakage
13%)
Other 2%
Mixed ED: 37%
IG: vasoactive intestinal
polypeptide (VIP) +
phentolamine meyslate
(PM)
IG1/IG2:
Dose: 25 µg VIP, + 1mg
(G1) or 2 mg (G2)
phentolamine (dose of
MP was established for
each pts in the initial
non-randomized dose
assessment phase) in
.35 mL volume
Duration: 6 o
Frequency: 10
injections in 6mo
Compliance (96.5%)
(n/grp): 136/141
CG:
Dose: 35 mL solution
Duration: as IG
Frequency: two
injections in 6 mo
Compliance: as IG
Run In period: NR
Wash out period: at
least 36hrs between
injections
F/u duration (both on
and off treatment):
NR
Primary outcome results:
Erection suitable for intercourse (% of
injections):
IG1 75% vs. CG 12%
IG2 66% vs. CG 18%
Duration of erection, median in all grps:
56 min (range from 26 min in pts with
venous leakage to 92 min in min in
neurogenic pts)
OS with drug (%)
88% (108/136)
Satisfaction with auto-injector (%)
92% (111/136 participants)
Other outcomes assessed: response
of patients previously treated with one
or more alternative therapies
Withdrawals/drop-outs/loss to f/u, n
(%): n=35 (30 never used injections and
were removed)
WDAE, n (%): 6 (4)
TAE: reported for dose assessment +
RCT phase: % of injections with at
least one AE 65 vs. 68 vs. 27 (flushing
47 vs. 50 vs. 9; bruising in less than 8%
of injections and pain experienced only
on injection in 8% in CG alone; priapism
in n=1 IG1 equal to 0.1% of 962
injections); AE experienced in 91% vs.
93% vs. 65% of pts
SAE: 0
Ascertainment of outcomes
assessed: Diary entries, F/u
questionnaire