Beste apotheek van Nederland

C-76
Author
Funding
N; study design; eligibility
Participants
characteristics
Diagnosis details Intervention Outcomes
Stuckey (2003)
77
Funding
source: Pfizer
Inc, New York
N screened = 244
N randomized = 191
IG, n = 97
CG, n = 94
ITT analysis used for
primary outcome: NR
Inclusion: men 18 or older
with clinical dx of ED for at
least 6 mo and controlled
type 1 diabetes for longer
than 1 y (HbA1c levels <
11%); in a stable
heterosexual relationship
Exclusion: penile
anatomical deformities,
major psychiatric disorder,
hx of alcoholism, substance
abuse, SCI, MI, stroke, heart
failure, unstable angina,
nitrate use; severe
autonomic neuropathy,
diabetes secondary to
pancreatic damage;
cushings syndrome or
acromegaly
Age, mean
(range): 47(25­
69) y
Race (%): White:
96 vs. 91;
Black: 0 vs. 2;
Asian: 4 vs. 7
Co-morbidities:
unspecified GI 6
(9) vs. 5 (8);
unspecified
disorders of eye:
21 (32) vs. 14 (21)
HbA1C, %
(range): 9 (6-13)
Previous ED
treatment, %:
28.4 vs. 20.4
including IC, and
IU injections;
pump; and
sildenafil (reported
dose only in IG,
=28% used 50
mg, and 72%
used 100 mg)
Smoking status:
Current 40 vs. 29
Body weight,
mean (range):
80 (56-118) vs. 77
(53-139) kg
Concomitant
medications, %:
Insulin: 100 (all pts)
Oral antidiabetic: 3.2
vs. 2.1
Duration of ED,
mean (range):
5 (0.6-19) vs. 6 (0.7­
27)
Underlying
disease, %: CVD=
34 vs. 39;
hypertension= 30 vs.
33; Peripheral
vascular dx: 1 vs. 5;
DM 10 (15) vs. 8
(12)
Psychogenic ED,
%: 0 vs. 1
Physiologic ED, %:
79 vs. 66
Mixed ED, %: 21 vs.
33
IG: sildenafil citrate
CG: placebo solution
IG:
Dose: 50 mg, option to
titrate to 100 mg or 25
mg
Duration: 12 wks
Frequency: once/d
Compliance (%): 88
CG:
Dose: NA (titration as
IG)
Duration: 12 wks
Frequency: once/d
Compliance (%): 82
Run In period: 4 wks
Wash out period: NR
F/u duration: 12 wks
Primary outcome results:
IIEF Q3, improvement in mean scores
from baseline, %: 36 vs. 20; post tx,
mean (sd): 4 (0.5) vs. 3 (0.5)
IIEF, Q4, improvement in mean score
from baseline, %: 68 vs. 27; post tx,
mean (sd): post tx: 3 (0.5) vs. 2 (0.5)
GAQ, % yes: 66 vs. 29
Successful intercourse, %: 63 vs. 33
Other outcomes assessed: subgroup
analysis based on severity of ED for
IIEF- OF; SD, intercourse satisfaction
and OS (all values in figures); all sign
better in IG vs. CG
Withdrawals/drop-outs/loss to f/u: 8
(8) vs. 7 (7); including lack of efficacy: 2
(2) vs. 3 (3)
WDAE, n (%): 1 (1) vs. 2 (2)
TAE: 48.4vs. 14 (n of AEs); including
headache 20% vs. 7.5%; flushing 18%
vs. 3%; dyspepsia 8% vs. 1%; visual
disturbances 2% vs. 2% (headache,
flushing and dyspepsia in >5% of pts)
SAE, n (%): 0 vs. 1 (1)
Ascertainment of outcomes
assessed: IIEF, GAQ; Questionnaires,
personal diary logs