Beste apotheek van Nederland

Author
Funding
N; study design; eligibility
Participants
characteristics
Diagnosis details Intervention Outcomes
Althof (2006) 3
Funding
source: Pfizer
Inc.
N screened = NR
N randomized = 553
(combined from two studies
US, n=253; Brazil, Mexico,
Australia and Japan n=300)
IG, n = 274
CG, n = 279
ITT analysis used for
primary outcome: yes
Inclusion: men 18 or older
with documented ED (score
of 21 or less on IIEF)
Exclusion: BP of 90 mmHg
or less or 170/110 mmHg or
more; sign cardiac dx; use of
nitrates, nitric oxide donors,
or ritonavir; more than 6
dosed of sildenafil within 6
mo prior to study entry
Age, mean (sd):
56 (11) vs. 55 (12)
y
Race: White
55.5%; Black
15%; Asian 5.5%;
Other 23.5%
Co-morbidities, n
(%): NR
Previous ED
treatment: NR
Smoking status:
NR
Body weight,
mean (sd): 86
(16) vs. 85 (16) kg
Concomitant
medications, n (%):
Duration of ED,
mean (sd): 4.4 (4.5)
vs. 4.3 (4.4) y
Underlying
disease, n (%): Not
specific
Psychogenic ED, n
(%): 44 (16) vs. 55
(20)
Physiologic ED, n
(%): 119 (43) vs.
113 (41)
Mixed ED, n (%):
116 (41) vs. 106 (39)
IG: Sildenafil
CG: Placebo
IG:
Dose: NR
Duration: 12 wks
Frequency: NR
Compliance: NR
CG:
Dose: NA
Duration: NR
Frequency: NR
Compliance: NR
Run In period: NR
Wash out period: NR
F/u duration: 12 wks
(f/u intervals at 2, 4, 6, 8
wks)
Primary outcome results:
IIEF, LS mean change from baseline
(SE)
EF: 11.0 (0.5) vs. 4.8 (0.5), p<0.001
OF: 2.5 (0.2) vs. .0 (0.2), p<0.001
SD: 1.3 (0.1) vs. 0.6 (0.1), p<0.001
IcS: 5.2 (0.2) vs. 2.9 (0.2), p<0.001
OS: 3.8 (0.2) vs. 1.7 (0.2), p<0.001
Successful sexual attempts, mean
change %(sd): 59 (2.6) vs. 39 (42)
GEQ, frequency of achieved erections
at end of tx: 3.9 (1.5) vs. 2.7 (1.6),
p<0.001
Other outcomes assessed: SEAR
sexual relationship domain (sign more
improved in IG)
Withdrawals/drop-outs/loss to f/u, n
(%): NR
WDAE, n (%): 3 (1) vs. 1 (0.4)
TAE, n (%): 129 (46) vs. 88 (32);
included headache, flushing, dyspepsia,
and rhinitis
SAE, n (%): 1 (<1) vs. 1 (<1); one case
of coronary artery disease in sildenafil
grp and one case of urinary tract
infection in placebo
Ascertainment of outcomes
assessed: SEAR; self-esteem,
confidence and sexual relationship
satisfaction; IIEF, GEQ, self reported
event log
C-3