Beste apotheek van Nederland

C-58
Author
Funding
N; study design; eligibility
Participants
characteristics
Diagnosis details Intervention Outcomes
Padam-Nathan
(1998) 59
Funding
source: Pfizer
N screened = NR
N randomized =
IG, n = 163
CG, n = 166
ITT analysis used for
primary outcome: yes (last
observation carried forward)
Inclusion: men 18 or older,
with ED of more than 6 mo,
ED (ED aetiology
determined at screening by
medical hx, penile
tumescence test, IC injection
test, endocrine testing, and
penile duplex
ultrasonography)
Exclusion: penile
anatomical defects; SCI;
other sexual disorders; low
T; poorly controlled DM or
untreated proliferative
diabetic retinopathy;
psychiatric dx; active peptic
ulcer dx; hx of major
haematological, renal, or
hepatic abnormalities; recent
hx of CV dx, stroke, or MI, or
alcoholism; or substance
abuse; tx with nitrates,
androgens or trazodone
Age, mean
(range): 60 (26­
79) vs. 59 (31-81)
y
Race: NR
Co-morbidities,
(%): hypertension
24 vs. 28;
Hyperlipidemia 15
vs. 15; ischemic
heart dx 15 vs. 8;
DM (any type) 8
vs. 11; depression
3 vs. 3; radical
prostatectomy 9
vs. 11
Previous ED
treatment: NR
Smoking status:
NR
Body weight: NR
Concomitant
medications, n (%):
NR
Duration of ED,
mean (range): 5
(0.5-26) y
Underlying
disease, n (%): NR
Psychogenic ED, n
(%): NR
Physiologic ED, n
(%): NR
Mixed ED, n (%):
NR
IG: Sildenafil
CG: Placebo
IG:
Dose: 50 mg (titrated to
100 mg, or 25 mg at 2
wks based on effecacy
and tolerability); total 32
doses
Duration: 12 wks
(median=87 d)
Frequency: up to one/d
(approximately 1 hr
before sexual activity)
Compliance: NR
CG:
Dose: NA/ total of 29
doses
Duration: 12 wks
(median = 86 d)
Frequency: as IG
Compliance: NR
Run In period: 4 wks
no tx
Wash out period: NR
F/u duration: 12 wks
Other: 23% of pts were
on 50 mg; 74% on 100
mg at the end
Primary outcome results:
GEQ, (% yes): 101/136 (74%) vs.
23/118 (16%), p<0.0001
Erection sufficient for intercourse, n (%):
94/137 (69) vs. 32/138 (23)
Maintaining erection after penetration, n
(%): 85/137 (62) vs. 22/138 (16)
Maintaining erection on most occasions,
n (%): 81/137 (59) vs. 21/138 (15)
Successful intercourse, (%): 65% vs.
20%, p < 0.001
Frequency of successful intercourse
attempts (n/mo): 5.9 vs. 1.5, p <0.0001
Other outcomes assessed: partner
assessment of sexual performance
Withdrawals/drop-outs/loss to f/u, n
(%): 9 (8) vs. 13 (6)
WDAE, n (%): 1 (<1) vs. 2 (1)
TAE, n (%): AE in at least 5% of pts=
headache 30 (18) vs. 6 (4); flushing 30
(18) vs. 1 (1); dyspepsia 9 (6) vs. 4 (2);
abnormal vision (▲ sensitivity or light or
blurred vision) NR (3) vs. NR (1)
SAE, n (%): NR
Ascertainment of outcomes
assessed: GEQ; pts log (sexual
stimulation, and successful intercourse);
optional two item partner questionnaire;
IIEF (15 item version); AE by examiner