Beste apotheek van Nederland

C-39
Author
Funding
N; study design; eligibility
Participants
characteristics
Diagnosis details Intervention Outcomes
Incrocci (2001)
40
Funding
source: Pfizer
B.V., The
Netherlands
N screened = 82
N randomized = 60 (crossover)
IG/ CG = 30
ITT analysis used for
primary outcome: No
Inclusion: men with
progressive ED after
3-dimensional conformal
external beam radiotherapy
(3D-CRT) for prostate who
agreed to perform sexual
activity at least once/ wk; in
a stable relationship
Exclusion: hx of MI or CVA,
prior radical prostatectomy;
post-radiotherapy rise in
PSA; use of nitrates or
hormone therapy
Age, mean: 68 y
Race (%): NR
Co-morbidities
(unrelated to
disease): NR
Previous ED
treatment: None
Smoking status:
NR
Body weight: NR
Other:
PSA/micrograms,
mean (range): 8.5
(1-227) litre
Concomitant
medications: NR
Duration of ED,
mean (range): time
from radiation to trial
39 (15-55) mo
Underlying disease
(%): Hypertension:
10%; DM 3%;
Transurethral
resection of the
prostate: 18%
Psychogenic ED:
NA
Physiologic ED:
100%
Mixed ED: NA
IG: sildenafil
CG: placebo
IG1:
Dose: 50 mg with option
to increase to 100 at 2
wks, or decrease to 25
mg in case of AE
Duration: 6 wks
Frequency: at least
1/wk, up to 1/d
Compliance (%): 100%
CG:
Dose: NA
Duration: 6 wks
Frequency: at least
1/wk, up to 1/d
Compliance (%): 100%
Run In period: 4 wks
Wash out period: NR
F/u duration: 12 wks
(assessments at end of
each 6 wks period)
Other: 90% patients ▲
dose to 100 milligrams,
0% ▼ to 25 mg
Primary outcome results:
IIEF baseline mean; post tx mean (sd)
IG vs. CG
Q1: 1.7; post 2.9 (1.6) vs. 1.8 (1.1)
Q2: 1.5; post 2.8 (1.8) vs. 1.5 (1.1)
Q3: 1.5; post 2.8 (1.7) vs. 1.6 (1.1)
Q4: 1.3; post 2.6 (1.7) vs. 1.5 (1.0)
Q5: 1.6; post 2.8 (1.1) vs. 1.8 (1.4)
Q6: 1.2; post 2.8 (1.1) vs. 2.4 (1.0)
Q7: 1.9; post 2.7 (1.6) vs. 1.9 (1.3)
Q8: 1.6; post 2.8 (1.4) vs. 1.9 (1.1)
Q10: 2.1; post 3.0 (1.6) vs. 2.4 (1.6)
Q11: 2.8; post 3.0 (1.1) vs. 2.8 (1.2)
Q12: 2.7; post 3.0 (1.0) vs. 2.6 (1.0)
Q13: 2.3; post 3.0 (1.4) vs. 2.3 (1.2)
Q14: 2.7; post 3.2 (1.4) vs. 2.8 (1.4)
Q15: 2.1; post 3.0(1.1) vs. 2.4 (1.3)
GEQ, % with improved: 45 vs. 8
Successful intercourse %: 55 vs. 18
Other outcomes assessed: NA
Withdrawals/drop-outs/loss to f/u: 0
WDAE: 0
TAE:
AEs (%)= headache: 42 vs. 15;
flushing: 13 vs. 2; myalgia 15 vs. 13;
nasal congestion 22 vs. 12; dyspepsia
32 vs. 8; dizziness 17 vs. 10
SAE: 0
Ascertainment of outcomes
assessed: IIEF; GEQ