Beste apotheek van Nederland

C-199
Author
Funding
N; study design; eligibility
Participants
characteristics
Diagnosis details Intervention Outcomes
Shabsigh (2000)
210
Funding
source:
Schwarz
Pharmaceuticals
AL
N screened = NR
N randomized = 111 (two
phase cross over study,
Phase I: office dose titration;
phase II: at home treatment)
IG1/IG2, n = 111
CG, n= NA
ITT analysis used for
primary outcome: yes
(Phase I, n= 95; Phase II, n=
68)
Inclusion: ED at least 6 mo,
stable heterosexual
relationship
Exclusion: pts with past IC
or IU tx, chemotherapy,
other meds that might
produce bleeding or bruising
after drug administration,
monoamine oxidase
inhibitors up to 2 wk before
enrolment, \concomitant
medication for ED or oral
alpha-adrenergic receptor
blocking agents, had ED due
to urologic abnormality,
penile fibrosis or untreated
endocrine disorder
(hypogonadism) or systolic
BP < 100 mm Hg
Age, mean (sd):
59.2 (10.6) y,
range 30-79 y
Co-morbidities:
NR
Previous ED
treatment: NR
Smoking status:
NR
Body weight: NR
Other: Blood
pressure, mean
(sd):
Systolic: 139(15)
mm Hg
Diastolic: 83 (8)
mm Hg
Heart rate: 73 (10)
beats per minute
Concomitant
medications: NR
Duration of ED,
mean (sd): 5 (4) y
\
Underlying
disease: NR
Psychogenic ED:
NR
Physiologic ED:
NR
Mixed ED: NR
IG1: IC injection of
alprostadil (EDEX)
IG2: IU injection of
alprostadil (MUSE) with
option of ACTIS
IG1:
Dose: mean optimal
dose = 27.3 µg (up to
40 µg, also most
frequently used dose)
Duration: phase I=1-14
d; phase II=21 d
Frequency: phase
II=max of 9 IU/ 21 d
administrations in 21 d
Compliance: NR
IG2:
Dose: optimal dose =
921 µg (up to 1000 µg,
33% of all
administrations)
Duration: as IG1
Frequency: as IG1
Compliance: NR
Run In period: 1 to 14
d
Wash out period: NR
F/u duration: 3 wk off
treatment
Primary outcome results:
IG1 vs. IG2
Grade > 3, n (%):
By physician: 59 (62) vs. 19 (20)
Patient assessment: 63 (66) vs. 25 (26)
Positive buckling tests (1 kg), n (%): 58
(61) vs. 20 (21)
Erection sufficient for intercourse, (%):
82 vs. 47
Satisfaction rating mean: 6 vs. 3
IIEF score, baseline all vs. IG1 vs. IG2,
mean (sd):
EF Q1-5, 15: 9 (6) vs. 25 (7) vs. 17 (9)
Intercourse satisfaction Q6-8: 5 (4) vs.
11 (3) vs. 8 (4)
Other outcomes assessed: NA
Withdrawals/drop-outs/loss to f/u, n:
43 (phase I, 16; phase II, 27)
WDAE: NR
TAE: pts with at least 1 AE [phase I];
[phase II], (%): [31 vs. 56], [53 vs. 58]
Application site reaction: [4 vs. 16], [2
vs. 10]
Other penile pain: [20 vs. 30], [34 vs.
25]
Prolonged erection: [2 vs. 0], [3 vs. 0]
SAE: 0
Ascertainment of outcomes
assessed: IIEF (Q1-5, 15; and Q9, 10;
and Q6-8; and Q13, 14), Buckling test;
grading system 0-3