Beste apotheek van Nederland

C-75
Author
Funding
N; study design; eligibility
Participants
characteristics
Diagnosis details Intervention Outcomes
Sommer (2007)
76
Funding
source: No
outside support
N screened = NR
N randomized = 112 (open
label; also reported on n=18
non randomized who
refused treatment)
IG, n = 56
CG, n = 56
ITT analysis used for
primary outcome: yes
Inclusion: men 20-70 y
with ED defined by IIEF –EF
score of <26 for at least 6
mo in duration with mild to
moderate, arteriogenic
aetiology and responsive to
ED treatments (PDE-5 or IC
injection)
Age, mean
(range): 44.7 vs.
46.1 y
Race: NR
Co-morbidities:
NR
Previous ED
treatment: NR
Smoking status:
NR
Body weight: NR
Other: BMI, mean
(kg/m 2 )= 26.9 vs.
27.7
Concomitant
medications: NR
Duration of ED,
mean: 4.3 vs. 5.5 y
Underlying disease
(% of pts): NR
Psychogenic ED
(%): NR
Physiologic ED
(%): NR
Mixed ED (%): NR
IG1: sildenafil
IG2: sildenafil
IG1-3:
Dose: 50 mg
Duration: 12 mo
Frequency: every
evening at bedtime
Compliance: NR
IG:
Dose: 50 or 100 mg on
demand for anticipated
sexual activity
Duration: 12 mo
Frequency:
Compliance: NR
Run In period: 4 wk
Wash out period: NR
Primary outcome results:
% of pts with normal (at least 26) IIEF­
EF at 12 mo: 32/48 (66.7%) [95% CI
51.6-79.6] vs. 33/49 (67.3%) [95% CI
52.5-80%]
28/48 (58.3%) [95% CI 43.2-72.4%] vs.
4/49 (8.2%) [95% CI 2.3-19.6%] had
normal EF domain scores 6 mo after
completing the course of study
Other outcomes assessed: PSV of
cavernous arteries improved by 11.2
cm/s (95% CI 4.7-21.4; p=0.012) from
25.8 (7.5) to 37 (10.4) after 4 wks
washout period (IG1); improved by 3.4
cm/s (95% CI –5.1-14.7; p=0.435)
Withdrawals/drop-outs/loss to f/u, n
(%): 8 (14.3) vs. 7 (12.5)
Exclusion: penile
anatomical abnormalities,
primary hypoactive SD, ED
of endocrine origin, radical
pelvic surgery without
erection, poorly controlled
DM, or clinically sign. liver
kidney, CV, or CNS
disorders. Non responders
to ED treatment (8 trials of
sildenafil 100 mg, or 40 µg
IC injection of PgE1), also
pts with concurrent tx with
nitrates, androgens or
anticoagulants
ED severity at
baseline, IIEF-EF:
Severe=0
Moderate (11-16),
16 (29) vs. 20 (36)
Mild to moderate
(17-21) 28 (50) vs.
28 (50)
Mild (22-25) 12
(21) vs. 8 (14)
Peak flow velocity,
men (sd): 25.8
(7.5) vs. 23.1 (6.9)
cm/s
F/u duration: 18 mo WDAE, n (%): 4 (7) vs. 4 (7)
TAE, n (%): NR (AE included rhinitis in
one man (IG1) vs. headache in 5,
flushing in four, dyspepsia in four, and
rhinitis in two (IG2)
SAE: 0
Ascertainment of outcomes
assessed: IIEF