Beste apotheek van Nederland

C-36
Author
Funding
N; study design; eligibility
Participants
characteristics
Diagnosis details Intervention Outcomes
Heiman (2007)
37
Funding
source: Pfizer
Inc.
N screened = NR
N randomized = 180
IG, n = 86
CG, n = 94
ITT analysis used for
primary outcome: yes
(n=85 vs. n=91)
Inclusion: men 21 y or older
with ED (score of 21 or less
on Sexual Health Inventory
for Men) and in stable
relationship with female
partner; with satisfactory
sexual intercourse of 50% or
less as reported by their
female sexual partner
Exclusion: couple with sign.
dyspareunia or lifelong
sexual dysfunction or men
with more than six doses of
any ED tx including PDE-5
inhibitor within 6 mo; use of
nitrates, nitric oxide donors;
medical or psychological
conditions (i.e. CV, arthritis,
hx of retinitis pigmentosa)
Age, mean
(range): 58 (30­
86) y
Race: White 79%;
Black 7%; Asian
2%; other 12.5%
Co-morbidities, n
(%): NR
Previous ED
treatment: NR
Smoking status:
current smokers
15% vs. 19%
(43% never
smoked)
Body weight: NR
Concomitant
medications, n (%):
NR
Duration of ED,
mean (range): 4.7
(0.2-21.6) vs. 6.1
(0.1-34.7) y
Underlying
disease, n (%): NR
Psychogenic ED
(%): 16 vs. 12
Physiologic ED
(%): 59 vs. 62
Mixed ED (%): 24
vs. 27
Other: IIEF baseline
score, mean= 46.3
vs. 48.8; EF
domain=13.2 vs.
12.6; OF domain=
5.6 vs. 5.5; SD
domain=6.3 in both
grps; IcS=6.7 vs.
6.1; OS=5; Q7=2.3
vs. 2.1
IG: Sildenafil
CG: Placebo
IG:
Dose: flexible dose 25,
50, and 100 mg
Duration: 12 wks
Frequency: as needed,
30 min to 1 hr prior to
sexual activity
Compliance: NR
CG:
Dose: NA
Duration: as IG
Frequency: as IG
Compliance: NR
Run In period: 2 wks
Wash out period: NA
F/u duration: 12 wks
Primary outcome results:
IIEF, change from baseline mean (SE):
EF domain: 8.9 (1) vs. 3.4 (1)
OF domain: 1.5 (0.4) vs. 0.9 (0.4)
SD domain: 0.4 (0.2) vs. 0.1 (0.2)
ICS domain: 2.1 (0.3) vs. 0.8 (0.3)
OS domain: 2.1 (0.3) vs. 0.8 (0.3)
Q7: 1.5 (0.2) vs. 0.3 (0.2)
GEQ, % improved (95% CI):
GEQ-1: 69 (57-79) vs. 25 (16-36)
GEQ-2: 71 (60-80) vs. 30 (20-41)
Other outcomes assessed: responses
in partner; EDIT scores, SEAR
Withdrawals/drop-outs/loss to f/u, n
(%): 21 (12)
WDAE, n (%): 0
TAE, n (%): reported as tx related AE:
29 in 18 (21%) vs. 11 in 10 (11%) of
pts; including one severe case of rhinitis
in IG, and one severe headache in CG
Most common AE: headache,
vasodilatation, rhinitis, dyspepsia, and
abnormal vision or chromatopsia (n=3
vs. 1)
SAE, n (%): 0
Ascertainment of outcomes
assessed: EDITS; IIEF; Self-Esteem
And Relationship (SEAR)