Beste apotheek van Nederland

C-51
Author
Funding
N; study design; eligibility
Participants
characteristics
Diagnosis details Intervention Outcomes
Montorsi (1999)
52
Funding
source: Pfizer
Inc.
N screened = NR
N randomized = 514
IG1, n = 128
IG2, n = 132
IG3, n = 127
CG, n = 127
ITT analysis used for
primary outcome: yes
Inclusion: men 18 or older,
with at least 6 mo primary
clinical diagnosis of ED
Exclusion: SCI, hx of stroke
or MI in the last 6 mo or
longer, major hematologic,
renal or hepatic
abnormalities, receiving
regular tx with nitrates;
poorly controlled DM
Age, mean
(range): 56 (19­
77) y (slightly
older in IG3, range
30-76)
Race (%): NR
Co-morbidities, n
(range %):
Genitourinary
procedures: 57
(12-19%);
Essential
hypertension: 74
(11-17%); DM: 45
(7-10%);
Genitourinary
disease:
IG1 = 3 (2%)
IG2 = 6 (5%)
IG3 = 13 (10%)
CG = 5 (4%)
Depression: 1-2%;
Ischemic heart
disease: 1-2%
Previous ED
treatment: NR
Smoking status:
NR
Concomitant
medications: NR
Duration of ED (yr)
mean (range): 5
(0.5-30) y
Underlying disease
(diagnosis) (N or %
of diseased/ grp):
NR
Psychogenic ED, n
(%): 129 (25)
Physiologic ED: n
(%): 166 (32)
Mixed ED: 219
(42.5)
IG1/IG2/IG3: sildenafil
CG: placebo
IG1:
Dose: 25 mg (IG1); 50
mg (IG2); 100 mg (IG3)
Duration: 12 wks
Frequency: up to once/d
Compliance (%): NR
CG:
Dose: NA
Duration: 12 wks
Frequency: up to 1x/day
Compliance (%): NR
Run In period: 4 wks
Wash out period: NA
F/u duration (both on
and off treatment):
mean 85 d
Primary outcome results:
IIEF- EF, mean (values approximate
extracted from graph): pre 13;
Post IG 19 vs. 21 vs. 23 vs. CG 13
IEF- Q3, mean score:
IG1= 3.18; IG2= 3.65; IG3= 3.79 vs.
CG= 2.17 (IG vs. CG p<0.0001)
IIEF- Q4, mean score:
IG1= 2.99; IG2= 3.40; IG3= 3.63 vs.
CG= 1.96 (IG vs. CG p<0.0001)
GEQ, % improved: IG1=67%;
IG2=78%; IG3=86%; vs. CG=24%
Successful intercourse attempt,
mean/mo: range 4.4-5.8 vs. 1.6
Other outcomes assessed: OF,
intercourse satisfaction, OS (values NR;
IG vs. CG p<0.0001; partner
satisfaction
Withdrawals/drop-outs/loss to f/u: 6
(2) vs. 1 (<1%)
WDAE, n (%): 6 (1.6) vs. 1(0.8)
TAE, n (%): 63 (49), 80 (61), 92 (72) vs.
42 (33); most common AE (range % in
IG vs. CG)= headache 17-20% vs. 4%;
flushing 13-20% vs. 2%; dyspepsia 2­
11% vs. 2%; altered vision 0-11% (n 15
pts) vs. 2%; back pain 0-8% vs. 2%;
nausea 1-6% vs. 1%
SAE: NR (one case of MI in IG2)
Initial body
weight: NR
Ascertainment of outcomes
assessed: IIEF, GEQ, partner
questions