Beste apotheek van Nederland

Author
Funding
N; study design; eligibility
Participants
characteristics
Diagnosis details Intervention Outcomes
Zinner (2007) 84
Funding
source: Pfizer
Inc. (conflict of
interest: author
has spoken for
Pfizer)
N screened =
N randomized = 48 (double
cross over design- impact of
food)
IG/CG 1&2, n = 24
IG/CG 3&4, n = 24
ITT analysis used for
primary outcome: NR
Inclusion: men 18 or older
in a stable relationship or 6
mo or longer taking 50 or100
mg sildenafil; with IIEF of 25
or less and minimum 4
sexual attempts/ mo
Exclusion: no response to
sildenafil 100 mg; CVD in
last 3 mo; current use or
likely prescription of nitric
oxide donors; use of an
alpha-blocker; use of other
ED tx; hx of retinitis
pigmentosa; tx with ritonavir,
or an investigational drug
within 6 wks of screening;
any known medical or
psychological conditions;
blood donation within 4 wks;
drug or alcohol abuse;
potential non-compliance
Age, mean
(range): 57 (29­
79) y
Race: NR
Co-morbidities, n
(%): heart disease
IG1&2= 4 (16.7)
IG3&4 =1 (4.2)
Previous ED
treatment: 100%
had been treated
with sildenafil 50
or 100 mg
Smoking status:
NR
Body weight: NR
Other:
recreational drug
use, n (%)
IG1-2= 14 (58.3)
IG3-4= 19 (79.2)
Concomitant
medications, n (%):
NR
Duration of ED: NR
Underlying
disease, n (%): NR
Psychogenic ED, n
(%): NR
Physiologic ED, n
(%): NR
Mixed ED, n (%):
NR
IG1-4: Sildenafil
CG1-4: placebo
IG1-4 (sildenafil):
Dose: 100 mg
Duration: 16 wks (4 wk
s/ tx period)
Frequency: 1 hr berore
meal (IG1); 30-60 min
before sexual activity
(IG2&4); during meal
(IG3)
Compliance:
CG1-4 (placebo):
Dose: NA
Duration: 16 wks as IG
Frequency: 30-60 min
berore coitus (IG1&3); 1
hr before meal (IG2);
during meal (IG4)
Compliance:
Run In period: 1-2 wks
(stopped sildenafil
dosing)
Wash out period: NR
F/u duration: end of
each tx period
Primary outcome results:
IG1 vs. IG2 & IG3 vs. IG4
IIEF-EF change from baseline, mean:
11.4 vs. 11.4 & 11.2 vs. 11.2
SEP-Q2 intercourse attempts:
93.9% vs. 91.8% & 91.4% vs. 92.6%
SEP-Q3: 84.7% vs. 85.9% & 83.4% vs.
87.5%
Time between dosing and intercourse
attempt ▼ responses to SEP-3 (from
max 92.8% at 1.5-2 hr to 81.6% when
taken >10 hrs prior to coitus)
Other outcomes assessed: mean
interval between dosing and coitus in
IG2 & IG4 =1.3 (0.6) & 1.1 (0.5) hr
Intervals between dosing and coitus in
IG1 & IG4= 4.8 (1.8) & 3.6 (1.9) hr
No sign differences for EDITS
responses or preference and
satisfaction for any of the regiments
Withdrawals/drop-outs/loss to f/u, n
(%): NR
WDAE, n (%): NR
TAE: NR
SAE, n (%): NR
Ascertainment of outcomes
assessed: IIEF; SEP- Q2 & 3; EDITS
List of abbreviations: %=percent, ▲=increased, ▼=decreased, AE=adverse event, SAE=serious adverse event, BMI=body mass index, CC=controlled clinical trials,
CG=comparator/control group, ctrls=controls, DM=diabetes mellitus, E 1 IC=intracavernosal injection, ECG=electrocardiograms, ED=erectile dysfunction, EDV=end-diastolic velocity,
f/u=follow-up, FMD=flow mediated dilation, GAQ=global assessment question, GEQ=global efficacy question, grp=group/s, HbA1C=haemoglobin, hr=hour(s), hx=history,
IG=intervention group, IIEF= international index of erectile function (EF=erectile function, OF=orgasmic function, OS=overall satisfaction, SD=sexual desire), ITT=intent-to-treat (Y =
yes, N = no, NR = not reported), IU=intraurethral, kg=kilograms, lbs=pounds, LUTS=lower urinary tract symptoms, M=male, max=maximum, mo=month(s), NA=not applicable,
PADAM=partial androgen deficiency of the aging male, PgE 1 =Prostagladin, PRL=prolactin, PSA=prostate-specific antigen, RAU=rigidity activity unit, RCT=randomized control trial,
SBP=systolic blood pressure, sign.=significant; TAE=total adverse events, TAU=tumescence activity unit, vs.=versus, WDAE=withdrawals resulting from adverse events, wk=week(s),
yr=year(s).
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