Beste apotheek van Nederland

Author
Funding
N; study design; eligibility
Participants
characteristics
Diagnosis details Intervention Outcomes
Ziegler (2006)
115
N screened = NR
N randomized = 318 (82
sites in Germany)
IG, n = 163
CG, n = 155
ITT analysis used for
primary outcome: yes (IG
n=153, CG n=149)
Inclusion: men 18 or older
with ED (by NIH Consensus
statement); established DM
type I; PDE5i naïve
Exclusion: penile
abnormalities; hx or SCI,
hepatitis B, C; MI; heart or
liver conditions (explicitly
reported); hypo/
hypertension; uncontrolled
DM; hx of malignancy within
past 5 y or serum creatinine
levels > 2.5 mg/dL (pts were
prohibited to take nitrates
while in the trial); tx with
anticoagulant drugs (except
anti-platelets); androgens,
alpha1-antagonists, potent
HIV protease inhibitors, anti
mycotic agents itraconazole
and ketoconazole, and
erythromycin; other ED tx
within 7 d of trial entry
Age, mean (sd): Concomitant
50.3 (9.7) y medications, n (%):
NR
Race: NR
Duration of ED: NR
Co-morbidities
(%): CV 157 Underlying
(51.8); nervous disease, n (%): DM
system 94 (31);
eyes 90 (29.7); Psychogenic ED, n
endocrine/ (%): NA
metabolic 83
(27.4);
Physiologic ED, n
musculoskeletal (%): all, 100%
system 49 (16.2);
urinary tract 46 Mixed ED, n (%):
(15.2); other NR
including allergies
28 (9.3)
Other: Glycemic
control, good (HbA 1c
Previous ED 7% or less) in 43 vs.
treatment: NR 51%; moderate
Smoking status: (HbA 1c 7-8%) in 58
NR
vs. 47%; poor
(HbA 1c >8%) 53 vs.
Body weight, 51%
mean (sd): 85.8
(13.4) kg
Other: BMI, mean
(sd): 27.2 (3.8) vs.
26.9 (3.4) kg/m 2
IG: Vardenafil
CG: Placebo
IG:
Dose: flexible dose
starting with 10 mg (5
mg for pts 65 or older)
titrated to 20 mg
Duration: 12 wks
Frequency: on demand
1 hr prior to intercourse,
up to 1/d
Compliance: NR
CG:
Dose: NA
Duration: as IG
Frequency: as IG
Compliance: NR
Run In period: 4 wks
no tx
Wash out period: NA
F/u duration: 12 wks
Dosing at 12 wks:
87.7% on 20 mg
vardenafil; 10.8% on 10
mg, and 1.5% on 5 mg
Primary outcome results:
IIEF domains change in score from
baseline, mean (sd):
EF: 7.79 (7.9) vs. 2.05 (5.8);
improvements unaffected by level of
glycemic control
IcS: 3.43 (3.6) vs. 0.72(2.45)
OF: 1.99 (2.6) vs. 0.30 (2.7)
SD: 0.67 (1.5) vs. 0.09 (1.4)
OS: 2.32 (2.6) vs. 0.52 (2.0)
SEP-2, mean % (sd);
Baseline: 41 (38) vs. 47 (40)
Post tx: 71 (35) vs. 52 (38)
SEP-2, mean % (from graph):
Baseline: 13 vs. 18
Post tx: 50 vs. 28
Other outcomes assessed: NA
Withdrawals/drop-outs/loss to f/u, n
(%): 16 (5.3) with no efficacy evaluation
at baseline or post tx
WDAE, n (%): 3 (1.8) vs. 2 (1.3)
TAE, n (%): 29.4 vs. 20.6; AE in 2% or
more pts n= 14 vs. n= 8; headache 5
(3.1) vs. 0; flushing 4 (2.5) vs. 0;
bronchitis 3 (1.84) vs. 4 (2.6);
nasopharyngitis 2 (1.2) vs. 4 (2.96)
SAE, n (%): 7 (4.6) vs. 3 (2), cause NR
Outcome ascertainment: IIEF-EF;
SEP2, and 3
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).
C-104