Beste apotheek van Nederland

C-55
Author
Funding
N; study design; eligibility
Participants
characteristics
Diagnosis details Intervention Outcomes
Olsson (2000) 56
Funding
source: NR
N screened = NR
N randomized = 351
IG1, n = 90
IG2, n = 85
IG3, n = 81
CG, n = 95
ITT analysis used for
primary outcome: NR
Inclusion: men 18-70 y with
diagnosis of ED of at least 3
mo duration, who had at
least a grade 3-4 (hard
enough for penetration-fully
rigid) erection at any time
during 4 wks before entering
the trial or positive response
to papaverine (at least 40
mg) or PGE1 (at least 20
mg)
Exclusion: Men with ED of
organic causes; tx with
nitrates, resting hypotension,
uncontrolled hypertension,
stroke, bleeding disorder,
active peptic ulceration,
taking anticoagulants, and a
hx of a major
haematological, renal,
hepatic disorders
Age, mean
(range): 52 (24­
70) y
Race (%): NR
Co-morbidities:
NR
Previous ED
treatment, n (%):
IG: 102 (40)
CG: 41 (43)
Smoking status:
NR
Body weight: NR
Concomitant
medications: NR
Duration of ED,
mean (range): 5
(0.2-40) y
Underlying
disease: NR
Psychogenic ED, n
(%): 153 (60) vs. 51
(54)
Physiologic ED:
2 (1) vs. 0
Mixed ED, n (%):
101 (39) vs. 44 (46)
IG1-3: sildenafil
CG: placebo
IG1-IG3:
Dose: 10 mg (IG1), 25
mg (IG2), 50 mg (IG3)
Duration: 4 wks
Frequency: once/d
Compliance: NR
CG:
Dose: NR
Duration: 4 wks
Frequency: once/d
Compliance: NR
Run In period: NR
Wash out period: NR
F/u duration: 6 wks
Primary outcome results:
IG (1-2-3) vs. CG
Mean N of grade 3-4 erections at wk 4,
mean n: baseline: 2.1; post tx: 2.8 -3.0 ­
3.6 vs. 1.8, p < 0.001 (IG vs. CG)
GAQ, %: 64 -79 - 88 vs. 38, p < 0.001
Mean Sexual Function Questionnaire
(SFQ) scores =improved in IG vs. CG
% Partners reporting improved erection:
64 -78 - 83 vs. 39, p < 0.001
Other outcomes assessed: NR
Withdrawals/drop-outs/loss to f/u, n
(%): 7.8 - 8.2% vs. 13.6% vs. 9.5%
WDAE, %: 2.2 -4.7- 8.6 vs. 4.2
TAE, %: 24.3 – 58.8 - 45 vs. 15%
AE in at least 5% of pts, n (%):
headache 12-20-16 (13-24-20) vs. 7 (7);
dyspepsia 4-9-5 (4-11-6) vs. 3 (3);
flushing 4-7-7 (4-8-9) vs. 0; myalgia 1-3­
6 (1-4-7) vs. 1 (1); arthralgia 1-6-0 (1-7­
0) vs. 1 (1); flue syndromes 0-5-2 (0-6­
3) vs. 2 (2); other (NR) 1-0-2 (1-0-3) vs.
0
SAE, n (%): n=3 (MI, renal cell
carcinoma, epileptic crisis)
Ascertainment of outcomes
assessed: Questionnaire; GAQ; SFQ
(15 question, of 14 d diary)