Beste apotheek van Nederland

C-179
Author
Funding
N; study design;
eligibility
Participants
characteristics
Diagnosis details Intervention Outcomes
Sandhu (1999) 187
Companion: 164
Funding source:
Senetek plc
N screened = 304 (dose
assessment phase) *
N randomized = 240
[cross over, intervention (a
and b); and placebo]
IG, n= 240 (133 phase II,
maintenance phase)
ITT analysis used for
primary outcome: yes
Inclusion: pts with ED > 1
y in duration, > 18y,
currently in stable
heterosexual relationship
Exclusion: overt
psychogenic aetiology,
ability, any known
systemic disease which
produces overall
weakness (other exclusion
criteria is listed in the
report)
*Note: non responders to
the non randomized dose
assessment phase
(details not reported in this
table) entered into phase
I, the result of which
reported in this table
Age, mean
(range):
58.5 (27-79) y
Co-morbidities:
NR
Previous ED
treatment:
IC Alprostadil: 106
IC Papaverine/
phentolamine: 45
Other (Yohimbine,
vacuum devices):
32
Smoking status:
NR
Body weight: NR
Concomitant
medications: NR
Duration of ED: NR
Underlying
disease:
atherogenic (n=58),
DM (n=53),
neurogenic (n=3),
mixed
Psychogenic ED: 0
Physiologic ED:
135
Mixed ED: 152
IG: vasoactive intestinal
polypeptide (VIP) +
Phentolamine
CG: placebo
IG a & b:
Dose: 25 μg VIP + a=1
mg, or b=2 mg (35 ml
volume)
Duration: 6 mo
Frequency: max 3
times/ wk
Compliance: 88.2%;
68.2% (133/195)
completed phase I;
94.7% (105/126)
CG:
Dose: placebo (35ml
volume)
Duration: as IG
Frequency: as IG
Compliance: as IG
Run In period: NR
Wash out period: 36
hrs between injections
F/u duration: NR
Primary outcome results: Duration of
erection, median, IGa vs. IGb vs. CG:
Phase I (n=132): 50 vs. 30 vs. 15 min
Phase II (n=126): 60 vs. 40 vs.27.5 min
Grade III erection, IG (a or b) vs. CG (a
or b) (%):
Phase I, a=72.2 vs. 13.1; b= 65.3 vs.
15.9; overall IG vs. CG=73.7 vs. 12.9
Phase II, a=75 vs. 12.6; b= 75 vs. 10.6;
overall IG vs. CG= 69.1 vs. 13.7
Other outcomes assessed: OS:
Satisfied or very satisfied: 80% of pts;
quality of life improvement: 81% of pts
and 76% or partners
Withdrawals/drop-outs/loss to f/u:
107 (44.5%): n=45 (18.8%) no injection,
n=62 post 1 st injection (AE, non
compliance, other)
WDAE: n=2 (death & priapism)
TAE (n): a vs. b vs. placebo: % of
injections with one or more AE: 47.5 vs.
45.4 vs. 68; bruising+ bleeding, 8 vs. 6
vs. 7; priapism (n=1) 0.05 vs. 0 vs. 0
Overall incidence of urethral bleeding
0.9% for both phases
SAE: death n=1 (also n=1 MI)
Ascertainment of outcomes
assessed: Home filled diaries, f/u
questionnaire