Beste apotheek van Nederland

Author
Funding
N; study design; eligibility
Participants
characteristics
Diagnosis details Intervention Outcomes
Becher (2002) 6
Funding
source: Pfizer
N screened = 156
N randomized = 143
IG, n = 72
CG, n = 71
ITT analysis used for
primary outcome: NR
Inclusion: Men with ED who
were in a stable relationship
with a female partner of at
least 6 mo
Exclusion: penile
anatomical defects, primary
diagnosis of another sexual
disorder, SCI, any major
psychiatric disorder not well
controlled, poorly controlled
DM, Hx of alcohol or
substance abuse, major
haematological, renal or
hepatic abnormalities,
hypotension or malignant
hypertension, recent stroke
or myocardial infraction or if
they were receiving nitrated.
Age, mean (sd);
57.2 (11.5) vs.
56.7 (10.9) y
Race, n (%):
White Southern
Latin 6 (8.3) vs. 7
(9.8)
Hispanic: 66
(91.7) vs. 64
(90.2)
Co-morbidities:
NR
Previous ED
treatment: NR
Smoking status,
n (%):Current: 32
(44.4) vs.27 (38.0)
Former: 28 (38.9)
vs. 26 (36.6)
Body weight,
mean (sd): 84.2
(11.8) vs. 83.4
(14.2)
Concomitant
medications, n (%):
Any medication 51
(70.8) vs. 51 (71.8),
with no sign
difference between
grps for use of any
medication
Duration of ED,
mean (range): 3.5
(0.5-22.4) vs. 2.6
(0.5-20.5) y
Underlying disease
(diagnosis), n (%):
Diabetes: 12 (16.6)
vs. 13 (18.3)
Hypertension: 23
(31.9) vs. 28 (43.6)
Psychogenic ED:
44.3%
Physiologic ED:
39.3%
Mixed ED:
16.4%
IG: Sildenafil
CG: Placebo
IG:
Dose: 25-50 and 100mg
tablets
Duration: 12 wks
Frequency: 1h before
planned sexual activity,
up to once/d
Compliance: 90%
CG:
Dose: NA (14
tablets/bottle as IG)
Duration: 12 wks
Frequency: as IG
Compliance: 89%
Run In period: 4 wks
Wash out period:
None
F/u duration: 12 wks
(2, 4, 8, and 12 wks)
Primary outcome results:IIEF mean
(SE):
% Change, Q3: 3.8 (0.17) (66.2) vs. 2.7
(0.18) (15.1)
% Change Q4: 3.6 (0.18) (77.6) vs. 2.5
(0.18) (21.2)
EF: 20.5 (0.6) vs. 15.9 (0.7)
OF: 8.2 (0.35) vs. 7.0 (0.37)
S-D: 7.68 (0.18) vs. 7.0 (0.19)
GEQ, % with Improved erections: (77.3)
vs. (33.8)
Other outcomes assessed: all IIEF
questions (1-15)
Withdrawals/drop-outs/loss to f/u, n
(%): 3 (2) vs. 2 (3)
WDAE, n (%): 7 (9.7) vs. 6 (8.5)
discontinued treatment
TAE, n (%): pts with AE 45 (59.1) vs.
21 (29.6)
Flushing: 16 (22.2) vs. 3 (4.2);
Headache: 17 (23.6) vs. 6 (8.4);
Hypertension: 1 (1) vs. 3 (4); nasal
congestion 2 (2.3) vs. 1 (1); tachycardia
3 (4) vs. 0
SAE: 2 (2.8) vs. 1 (1.4) died in due to
MI
Ascertainment of outcomes
assessed: RigiScan test (nocturnal
penile tumescence NPT), IIEF (q3 and
4) (investigator), GEAQ, self and
partner reported event logs
C-6