Beste apotheek van Nederland

C-25
Author
Funding
N; study design; eligibility
Participants
characteristics
Diagnosis details Intervention Outcomes
Fava (2006) 25
Funding
source: Pfizer
Inc. (conflict of
interest for
authors; paid by
Pfizer, and other
sources)
N screened = NR
N randomized = 142
IG1, n = 71
CG, n = 71
ITT analysis used for
primary outcome: NR
Inclusion: men 18 or older
with ED diagnosed by
Sexual Health Inventory for
Men (SHIM) score of 21 or
less, and diagnosed major
depressive disorder (MDD)
according to DSM-IV criteria
in remission in stable
relationship
Exclusion: symptomatic for
depression or anxiety
despite tx; pts requiring tx
with antipsychotics, mood
stabilizers, other
nonserotonergic
antidepressant agents or
lithium; use of nitrates or any
commercially available for
ED
Age, mean
(range): 51 (27­
74) y
Race, %: White
86 vs. 92%; Black
6 vs. 3%; Asian 3
vs. 0%; other 6%
in both grps
Co-morbidities, n
(%): NR
Previous ED
treatment: NR
Smoking status:
NR
Body weight,
mean (range): 92
(57-191) vs. 92
(60-138) kg
Concomitant
medications, n (%):
antidepressant
therapy, selective
SRI 133 (94);
serotoninnorepinephrine
reuptake inhibitor 10
(7); other
antidepressant
drugs 10 (7)
Duration of ED,
mean (range): 2.7
(0.1-14.2) vs. 2.2
(0.2-11.6) y
Underlying
disease, n (%):
depression
Psychogenic ED, n
(%): 100%
Physiologic ED: NA
Mixed ED: NR
IG: Sildenafil
CG: Placebo
IG:
Dose: 50 mg titrated to
up to 100 or down to 25
mg based on efficacy
and tolerance
Duration: 6 wks
Frequency: NR
Compliance:
CG:
Dose: NA
Duration: 6 wks
Frequency: NR
Compliance:
Run In period:
Wash out period:
F/u duration:
Other: mean dose
taken/ mo= 13.6 vs. 11;
65% on 100 mg 34% on
50 mg and 1% on 25
mg sildenafil at end of
study
Primary outcome results:
IIEF mean score:
Q3: baseline 2.4; post tx 3.9 vs. 3.1,
p=0.003
Q4: baseline 2.1; post tx 3.7 vs. 2.8,
P<0.001
GEQ- Q1, % improved: 70.6 vs. 28.8
GEQ-Q2, % improved: 72.1 vs. 27.7
GEQ-Q3, mean (SE) scale of 1-5: 2.5
(0.2) vs. 1.3 (0.2)
Event log, mean (SE) N of events/ wk:
N of sexual intercourse attempts: 2.6
(0.2) vs. 1.9 (0.2)
N of successful attempts: 1.9 (0.2) vs.
0.6 (0.2)
Successful attempts/ wk, % (95% CI):
71 (60 to 80) vs. 31 (22 to 43)
Other outcomes assessed:
All EDITS questions indicated tx
success with sildenafil
Withdrawals/drop-outs/loss to f/u, n
(%): 9 (12.7) vs. 4 (5.6)
WDAE: NR
TAE, n (%): NR; all included headache
6 (9) in all; dyspepsia 6 (9) vs. 1 (1);
anxiety 4 (6) vs. 3 (4); abnormal/ blurry
vision 2 (3) vs. 0
SAE, n (%): 0
Ascertainment of outcomes
assessed: IIEF, EDITS, GEQ