Beste apotheek van Nederland

Author
Funding
N; study design; eligibility
Participants
characteristics
Diagnosis details Intervention Outcomes
von Keitz (2002)
155
Funding
source: NR
N screened = NR
N randomized = 507
IG1, n = 254
CG, n = 253
ITT analysis used for
primary outcome: Y
Inclusion: heterosexual; in
stable health; aged 18-70;
hx of ED; some intrinsic
penile function; in stable
sexual relationship for ≥6 mo
Exclusion: MS, or SCI;
hypogonadism; serum T <
8.3 nmol/L; uncontrolled
diabetes; HbA 1C >10%;
episode of ketoacidosis in
last 3 mo; radical
prostatectomy; penile
prosthesis; penile deformity;
pelvic surgery; uncontrolled
hyper or hypotension; MI
within last 6 mo; unstable
angina; any major CV
impairment; hx of drug of
alcohol abuse; positive HIV
or hepatitis B surface
antigen; cancer with dx-free
interval <5 yr; ED
medication within last 2 wk
prior to randomization; hx of
allergic reaction to opiates
Age, mean
(range):
55 (22-70) y
Race (%): white
99
Co-morbidities:
NR
Previous ED
treatment: NR
Smoking status:
NR
Body weight: NR
Concomitant
medications, (%):
used at least one
medication, 63 vs.
51
Duration of ED: NR
Underlying
disease, (%):
Hypertension
24 vs. 19
CAD 1 vs. 10
Diabetes 10 vs. 8
Benign prostatic
hyperplasia 5.5 vs. 6
Psychogenic ED:
NR
Physiologic ED:
NR
Mixed ED: NR
IG: apomorphine SLsublingually
CG: placebo
sublingually
IG:
Dose: 2 mg initially, ▲
by 1 mg at 2 and 4 wk
(forced dose escalation
regimen)
Duration: 8 wk
Frequency: once/ 8 hrs
1/8 hrs
Compliance: NR
CG:
Dose: placebo
Duration: 8 wk
Frequency: as IG
Compliance: NR
Run In period: None
Wash out period: NA
F/u duration: 8 wk
Primary outcome results:
Erections sufficient for intercourse (%):
62 vs. 55 (p=0.021)
Successful attempts resulting in sexual
intercourse (%):
Overall: 38 vs. 28
3 mg apomorphine vs. CG: 35 vs. 26
Other outcomes assessed: NR
Withdrawals/drop-outs/loss to f/u, n
(%): 33 (13) vs. 33 (13)
WDAE, n (%): 12 (5) vs. 4 (2)
TAE: 400 (in n=158) vs. 131 (in n= 62)
SAE: 9 in n=6; 3 events considered
related to study drug:
IG1: syncope and vomiting in n=1
CG: angina pectoris of moderate
intensity in n=1
Ascertainment of outcomes
assessed: diary card
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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