Beste apotheek van Nederland

C-42
Author
Funding
N; study design; eligibility
Participants
characteristics
Diagnosis details Intervention Outcomes
Katz (2005) 43
Funding
source: Pfizer
N screened = 202
N randomized = 137
(parallel design)
IG, n = 63
CG, n = 74
Intention to Treat (ITT):
Yes (IG, n=60; CG n=72)
Inclusion: men 18 y or
older, with ED, (Sexual
Health Inventory for Men
score of 21 or greater), &
documented evidence of
stable coronary heart failure
(CHF); naïve to sildenafil
(discontinue at least by
screening visit)
Exclusion: hypotension,
high cardiac risk, CHF
secondary to hypertrophic
cardiomyopathy; hx or
myocarditis or implantable
defibrillator firing 6 mo prior
to entry; use of organic
nitrates, drugs that inhibit
cytochrome P450 (i.g.
ritonavir)
Data reported as IG vs. CG
(unless otherwise indicated)
Age, mean
(range): all, 60
(38-83) y
Race (%): NR
Co-morbidities:
all pts had one or
more conditions
including diabetes,
hypercholestrrole
mia, hypertension,
ischemic heart dx,
past coronary
bypass
Previous ED
treatment: NR
Smoking status:
22% in both grps;
19% vs. 33% were
ex-smokers
Concomitant
medications: ACE
inhibitors;
angiotension II
receptor antagonist
(29% vs. 15%); β
blockers; loop
diuretics, cardiac
glycosides, oral
anticoagulants,
analgesics fro mild
to moderate pain
(11% vs. 22%)
Duration of ED,
mean (range): 5
(0.1-22) y
Underlying
disease: CHF,
duration of 6 (0.27­
31.7) vs. 4.8 (0.03­
22.2) y
Psychogenic ED,
%: 2 vs. 1
Physiologic ED, %:
57 vs. 56
Mixed ED, %: 41 vs.
43
IG1: Sildenafil
CG: placebo
IG1:
Dose: 50 mg, adjusted
to 25 or 100 mg based
on pts tolerability &
efficacy
Duration: 12 wk
Frequency: NR
Compliance (%): NR
CG:
Dose: NR
Duration: as IG
Frequency: NR
Compliance (%): NR
Run In period: 2 wks
Wash out period: NA
F/u duration: 12 wks
Primary outcome results:
Baseline (mean); post tx (least square
mean) scores:
Q3 (improved erections): pre=1.7; post:
3.7 vs. 2.8 (p=0.0003); [74% of pts vs.
18% improved, (<0.002)]
Q4 (improved intercourse), mean score:
pre=1.4 post: 3.3 vs. 2.4 (p = 0.0012);
[68% vs. 16% improved (p<0.002)]
IIEF, EF: pre=33; post 71 vs. 53
IIEF Q9, 10: pre=45; post 77 vs. 67
IIEF Q11, 12: pre=61; post 69 vs. 63
IIEF, Q6, 8: pre= 35; post 69 vs. 55
IIEF, Q13, 14: pre=39; post: 79 vs. 58
Intercourse success (%): 53 vs. 20,
Improved erection, %: 74 vs. 18
Improved intercourse, %: 68 vs. 16
Other outcomes assessed: IIEF Q 5­
12; GEQ; life satisfaction check list;
EDITS
Withdrawals/drop-outs/loss to f/u: 20
(16) vs. 10 (14)
WDAE: 2 (3) vs. 2 (3)
TAE: (% of pts) 60% vs. 48%
(headache 13% vs. 3%, also respiratory
tract infection, asthenia, peripheral
edema, rhinitis, back pain, rash, pain in
both grps; vasodilatation; ▲ cough,
neoplasm, chromatopsia only in IG)
SAE: 3% vs. 5%
Ascertainment of outcomes
assessed: self administered IIEF;
GEQ, EDITS