Beste apotheek van Nederland

C-34
Author
Funding
N; study design; eligibility
Participants
characteristics
Diagnosis details Intervention Outcomes
Gopalakrishnan
(2006) 35
Funding
source:
Christian Medical
College grant;
Sun
Pharmaceuticals
provided the
medication
N screened = 150 (40 were
identified with ED)
N randomized = 32
(randomized two way cross
over)
IG/CG, n = 32
ITT analysis used for
primary outcome: yes
Inclusion: married men with
schizophrenia or delusional
disorder on current tx; with
ED
Exclusion: regular use of
nitrates, anticoagulants, or
aspirin 2 wks prior to study
entry; comorbid depressive
syndrome; tx with
antidepressants; alcohol or
other substance
dependence; hx of use of
sildenafil citrated and
continued use of other
measures to improve ED
Age, mean (sd):
35.1 (5.5), range
24-45 y
Race: NR
Co-morbidities, n
(%): paranoid
schizophrenia 20
(62.5); catatonic
schizophrenia 1
(3),
undifferentiated
schizophrenia 5
(16), delusional
disorder 3 (9.3),
Previous ED
treatment: NR
Smoking status:
NR
Body weight: NR
Concomitant
medications: all pts
on chlorpromazine
equivalents dose
556.3 (198.6) range
200-1000 mg; mean
dose of
trihezyphenidyl 1.2
mg/d; 3 pts also on
diazepam
Duration of ED: NR
Underlying
disease, n (%): as
in comorbid
conditions
Psychogenic ED, n
(%): 10%
Physiologic ED, n
(%): 0
Mixed ED, n (%):
NR
IG: Sildenafil
CG: Placebo
IG:
Dose: 25 mg titrated to
50 mg based on
efficacy outcomes at 1st
wk
Duration: 2 wks
Frequency: up to 1/d
Compliance: 100%
CG:
Dose: NA
Duration: 2 wks
Frequency: as IG
Compliance: 100%
Run In period: NR
Wash out period: none
F/u duration: end of
each 2 wks period
Primary outcome results:
N of grade 3 or 4 erections, mean (sd)
combined for two wks of tx:
6.52 (3.92) vs. 3.32 (3.5); P< 0.001
duration of erection, mean (sd): 3.38
(2.25) vs. 2.20 (2.14) min, P<0.055
Combined N of satisfactory intercourse
attempts, mean (sd): 5.29 (3.84) vs.
2.45 (3.33); P<0.001
Other outcomes assessed: tx
interaction effects (NS)
Withdrawals/drop-outs/loss to f/u, n
(%): 1(3)
WDAE, n (%): 0
TAE: 13 (41) vs. 3 (9.3)
AEs, n (%): nasal congestion 4 (12.5)
vs. 0; headache 3 (9.4) vs. 1 (3.1); loss
of appetite 1 (3.1) vs. 0; retarded
ejaculation 2 (6.3) vs. 1 (3.1); dyspeptic
symptoms 1 (3.1) vs. 1 (3.1); giddiness
1 (3.1) vs. 0; rash 1 (3.1) vs. 0
SAE, n (%): NR
Ascertainment of outcomes
assessed: pts log