Beste apotheek van Nederland

C-86
Author
Funding
N; study design; eligibility
Participants
characteristics
Diagnosis details Intervention Outcomes
Goldstein (2003)
89
Funding
source: Bayer
Corporation
N screened = 452
N randomized = 452
IG1, n = 153 (ITT = 149)
IG2, n = 149 (ITT= 141)
CG, n = 150 (ITT= 140)
ITT analysis used for
primary outcome: Yes
Inclusion: men older than
18 y, and clinical diagnosis
of type 1 or type 2 DM, Ed of
6 mo or longer. HbA1c
>12%.
Exclusion: ED due to
radical prostatectomy,
hypoactive SD; SCI. MI,
stroke, ischemia; sign
arrhythmia; uncontrolled
atrial tachyarrhythmia,
unstable angina pectoris,
liver dx, haematological dx
or bleeding disorder, resting
hypo/hypertension, retinitis
pigmentosa, progressive
retinopathy, autonomic
neuropathy, migraine
headaches; AE or
dissatisfaction with
Sildenafil; Nitrates, anti
androgens, anti coagulant
androgens, trazodone
hypochloride not allowed
Age, mean (sd):
57 (NR) y
Race n (%): White
350 (80); Black 41
(9); Hispanic 15
(8) Other 13 (3)
Co-morbidities, n
(%): Hypertension
231(53);
depressive dx 45
(10)
HbA1C levels, n
(%): < 6 = 12 (3);
> 6 to < 8= 192
(43)
> 8.0 = 231 (53)
Previous ED
treatment n (%):
Sildenafil 256 (58)
Body weight: NR
Other: Severity of
ED n (%): Severe
(<11)=240 (55);
Moderate (11-16)
102 (23); Mild to
Moderate (17-21):
68 (15); Mild (22­
25): 26 (9);
Normal (> 26): 3
(<1), only in IG2 &
CG
Concomitant
Medications, n (%):
Beta Blockers 52
(12); Reninangiotension
system
acting agents 210
(50); Calciumchannel
blockers 45
(10); Serum lipidreducing
agents 146
(33); Diuretics 71
(16);
Other
antihypertensives 40
(9); Insulin 152 (35);
Glucose-lowering
drugs 318 (72)
Duration of ED: 3.5
y
Underlying
disease: 88% type 2
diabetes and poor
glycemic control
Psychogenic ED:
2 (<1) only in IG1: 2
(1)
Physiologic
(organic) ED, n (%):
358 (81)
Mixed ED: 77 (18)
IG1: vardenafil
IG2: vardenafil
CG: Placebo
IG1:
Dose: 10 mg
Duration: 12 wks
Frequency: as needed,
no more than 1/day
Compliance: NR
IG2:
Dose: 20 mg
Duration: 12 wks
Frequency: as needed,
no more than 1/d
Compliance: NR
CG:
Dose: NA
Duration: 12 wks
Frequency: as needed,
no more than 1/d
Compliance: NR
Run In period: 4 wk
unmedicated phase
Wash out period: NR
F/u duration: 12 wk
Primary outcome results:
IG1 vs. IG2 vs. CG
IIEF-EF, mean final score: 17 vs. 19 vs.
13 (change from baseline: 1.4 vs. 6 vs.
8)
SEP-Q2, mean least square success
rate (%): 61 vs. 64 vs. 36 (in severe
ED= NR vs. 40 vs. 11; in mild ED= NR
vs. 75 vs. 47)
SEP-Q3, mean least square per pts
(%): 49 vs. 54 vs. 23 (type I diabetes=
48 vs. 65 vs. 10; type II= 49 vs. 52 vs.
25)
GAQ, proportion of men with improved
erection: 54% vs. 72% vs. 13%
Other outcomes assessed: Blood
chemistries, ECG
Withdrawals/drop-outs/loss to f/u: 73
(17)
WDAE, n (%): 4 (3) vs. 5 (3) vs. 2 (1);
headache, cutaneous flushing, rhinitis
TAE, n (%): 7 (5) vs. 9 (6) vs. 6 (4)
SAE, n: 3 (2) vs. 4 (3) vs. 4 (3);
including chest pain, dyspnea, larynx
edema, asthma (n=1); depression,
hypesthesia, or moderate amnesia; no
death occurred
Outcome ascertainment: IIEF, SEP,
Q2 and 3; GAQ, diary questions