Beste apotheek van Nederland

C-255
Author
Funding
N; study design;
eligibility
Participants
characteristics
Diagnosis details Intervention Outcomes
Speel (2005) 264
Funding
source:
N screened = 59
N randomized = 59
IG1, n = 30
CG, n = 29
ITT analysis used for
primary outcome:
None
Inclusion: Patients with
complaints of ED and
impaired cavernosal
perfusion as
demonstrated with
PPDU. Patients
between 35 to 75yrs.
Exclusion: Men with
penile implants; heart
failure or low ejection
fraction; uncontrolled
hypertension;
hypotension;
nephropathy or renal
artery stenosis;
abnormal kidney
function; dehydration;
taking diuretic;
myocardial infraction or
stroke within 4 wks;
hypersensibility for
ACE, participating in
any other trial; has
medical, psychiatric or
substance abuse
disorders, hx of
malignancy.
Age, mean (sd);
60 (6.8) yrs
Race: NR
Co-morbidities
(unrelated to disease):
NR
Blood glucose (or
HbA1C): NR
Previous ED
treatment: None
BMI (kg/m 2 ): NR
Smoking status:
NR
Body weight: NR
Concomitant
medications:
Sildenafil, self –
injection with
papaverine/
phentolamine prior to
sexual intercourse.
(70% used)
Duration of ED,
mean (95% CI) mo
IG1: 40 (25-55)
CG: 48 (29-67)
Underlying disease
(diagnosis): n (%)
IG1: 9 (30)
CG: 3 (10.3)
suffered from
diabetes
Psychogenic ED:
None
Physiologic ED:
None
Mixed ED: None
IG1: Quinapril
CG: Placebo
IG1:
Dose: 20mg
Duration: 26 – 46 wks
Frequency:once a
day
Compliance (%): (87)
CG:
Dose:
Duration: 26 – 46 wks
Frequency: once a
day
Compliance (%): (93)
Run In period: None
Wash out period:
None
F/u duration (on and
off treatment): day
14, wk 4, and 2 mo
Primary outcome (EF):
Change AT: -13 vs.-18
Change IMT: 0.03 vs. 0.01
Sexual Activity (% change): 8 vs. 20
Severe ED (% change): -32 vs. -35
Other outcomes assessed:
IIEF score erection domain (who were
sexually active) n (%)
>19 (mild): 4 (25) vs. 4 (24)
13-18 (moderate): 7 (44) vs. 6 (35)
5-12 (severe): 5 (31) vs.7 (41)
Withdrawals/drop-outs/loss to f/u: n
(%). IG1: 2 (6.7) were exclude for lack
of compliance. CG: 2 (6.9) Lack of
compliance
WDAE: n (%). IG1: 2 (6.7) dropped out
because of discomfort in the epigastria
region.
CG: 1 (3.4) had a stroke during study
1 (3.4) died during study because of
cerebral hemorrhage.
TAE: n (%). IG1: 3 (10) dry cough, 4
(13.3) nausea, 3 (10) joint and muscle
pain, and 1 (3.3) twinkle feeling in feet.
CG: 2 (6.9) epigastric pain, 1 (3.4) dry
cough, 1 (3.4) nausea, 1 (3.4)
headache.
SAE: n (%). CG: 1 (3.4) had a stroke
during study. 1 (3.4) died during study
because of cerebral hemorrhage.
Ascertainment of outcomes
assessed: Cavernosal acceleration
time measures during PPDU, IMT, and
EF determined by the erection domain
of the IIEF questionnaire. (Physician
and vascular technologist)