Beste apotheek van Nederland

C-31
Author
Funding
N; study design; eligibility
Participants
characteristics
Diagnosis details Intervention Outcomes
Goldstein (1998)
31
Study b
Funding
source: Pfizer
N screened = NR
N randomized = 329; (dose
escalation + open label
extension)
IG, n = 163
CG, n = 166
ITT analysis used for
primary outcome: yes
Inclusion: men in stable
relationship 6 mo or longer,
with ED confirmed by clinical
exam and IC injection of
vasoactive drug (31% of
men), normal NPT, penile
duplex ultrasonography, and
endocrine testing
Exclusion: penile
deformities, another sexual
disorder; SCI, major
psychiatric dx; poorly
controlled DM; peptic ulcer
dx, hx or alcohol or
substance abuse;
hematologic, renal or
hepatic abnormalities, recent
stroke or MI in last 6 mo;
nitrate therapy
Age, mean
(range): 60 (26­
79) vs. 59 (31-81)
y
Race: NR
Co-morbidities:
NR
Previous ED
treatment: NR
Smoking status:
NR
Body weight: NR
Concomitant
medications: NR
Duration of ED,
mean: 5 y
Underlying disease
(% of pts):
hypertension 24 vs.
28; ischemic heart
dx 15 vs. 8;
hyperlipidemia 15
vs. 14; hx or radical
prostatectomy 9 vs.
11; DM 8 vs. 11
Psychogenic ED, n
(%): 14 vs. 16
Physiologic ED, n
(%): 55 vs. 63)
Mixed ED, n (%): 31
vs. 22
IG: Sildenafil -oral
CG: placebo- oral
IG:
Dose: 50 mg (titrated at
each f/u visit to double
or 50% less based on
the therapeutic
response and AE)
Duration: 12 wk
Frequency: once/ d
(one hr before sexual
activity)
Compliance: 94
CG:
Dose: NA
Duration: 12 wks
Frequency: as IG
Compliance: 92
Run In period:
Wash out period:
F/u duration: 12 wk
(also at end of open
label study of 32 wks)
Primary outcome results:
IIEF, Q3/ Q4 mean (sd) score:
Baseline (IG=CG): 2 (0.1)/ < 2 (0.1)
post tx: 4 (0.1) vs. 2 (0.1)/ 4 (0.1) vs. 1.8
(0.1)
IIEF-EF, mean score: 22 vs. 12,
p<0.001
Successful attempts of sexual
intercourse (%): 69 vs. 22
Mean n of successful attempts in last 4
wks: 6 vs. 1.5
Improved erection, n (%): 101 (74) vs.
23 (19), p< 0.001
Other outcomes assessed: IIEF, Q6,
7, 8, 13 and 14 (> in IG); SD (no
change)
Withdrawals/drop-outs/loss to f/u, n
(%): 9 (6) vs. 13 (8), open label
(n=225)= 18 (8)
WDAE, n (%):
TAE, n (%): in 5% or more of all IG vs.
CG/ IG open label: headache 30(18) vs.
14 (6)/ 28 (12); flushing 30 (18) vs. 1
(1)/ 22 (10); dyspepsia 9 (6) vs. 4 (2)/
12 (5); rhinitis 8 (5) vs. 1(1)/ 4 (2); visual
disturbance 4(2) vs. 1 (1)/ 9 (4)
SAE: NR
Ascertainment of outcomes
assessed: IIEF; questionnaire for
clinical assessment of ED, & tx
outcomes; self report by event log; GAQ