Beste apotheek van Nederland

Author
Funding
N; study design; eligibility
Participants
characteristics
Diagnosis details Intervention Outcomes
Young (2005) 145
Funding
source: Lilly
ICOS LLC
(Bothell, Wash
and Indianapolis)
N screened = NR
N randomized = 483 (phase
III)
IG1, n = 161
IG2, n = 161
CC, n = 161
Note: pts further sub-divided
for efficacy analyses at 24 hr
post dosing (n= 80) & 36 hr
(n= 81) for all grps
ITT analysis used for
primary outcome: y
Inclusion: at least 18 y of
age, reported minimum of 3
mo hx of ED
Exclusion: clinically sign.
penile deformities or penile
implants, a recent hx of
stroke or spinal cord trauma,
unstable cardiovascular
status (e.g. unstable angina,
myocardial infarction, or
myocardial revascularization
within 90 days), use of
nitrates, cancer
chemotherapy, or
antiandrogens, failure to
achieve erection following
radical prostatectomy or
pelvic surgery.
Age, mean
(range): 57.4 (33­
82) vs.58 (26-75)
vs. 58(37-78) y
Race (%):
Caucasian 80 vs.
87 vs. 83; African
descent 10 vs. 8
vs. 14; Hispanic 8
vs. 5 vs. 2; other 2
vs. 0.6 vs. 2
Co-morbidities,
(%): DM 8 (11) vs.
11 (7) vs.15 (9);
hypertension 64
(40) vs. 64(40) vs.
60 (37); coronary
artery disease 5
(3) vs. 8(5) vs. (5)
Previous ED
treatment: NR
Smoking status,
n (%): current
smoker 27(17) vs.
26 (16) vs. 21(13)
Body weight: NR
Concomitant
medications:
testosterone (total =
22 pts) during post
baseline period
Duration of ED: 3
mo
Underlying
disease: NR
Psychogenic ED, n
(%): 16 (10) vs. 14
(9) vs.16 (10)
Organic ED, n (%):
109 (68) vs. 115 (71)
vs.100 (62)
Mixed ED, n (%):
36 (22) vs. 32 (20)
vs. 45 (28)
IG: tadalafil, 10 mg, oral
IG2: tadalafil, 20 mg,
oral
CG: oral placebo
IG
Dose: 10 mg
Duration: 4-6 wks
Frequency: 4 diff. times
at 24 or 36 hrs post
dosing, 7 d between
each dose
Compliance: NR
IG2
Dose: 20 mg
Duration: 4-6 wks
Frequency: as IG1
Compliance: NR
CG:
Dose: placebo
Duration: 4-6 wks
Frequency: as IG
Compliance: NR
Run in period: 4 wks +
2-4 wks equilibration
phase
Wash out period: 7 d
F/u duration: 4-6 wks
for efficacy6 mos openlabel
active medication
extension – results NR)
Primary outcome results:
SEP3, mean per pt % “yes” responses,
% change):
24-hrs IG (55.8%, ▲ 25.5%, p = 0.038),
IG2 (67.3%, ▲ 46.3%, p < 0.001) sign
superior vs. CG (41.8%, ▲9.4%)
36-hrs IG (56.2%, ▲ 23.9%, p< 0.001),
IG2 (61.9%, ▲28.7%, p<0.001) sign
successful vs. CG (32.8%, ▲1.9%)
Other outcomes assessed: SEP-Q1,
2,4,5
Withdrawals/drop-outs/loss to f/u, n
(%): 23 (4.8%)
WDAE (%): IG= 2, vs. CG= 0.6
TAE n (%): AE in 2% or more= 37 (23)
vs. 55 (34) vs. 9 (5.6); AE included
headache 9 (6) vs. 17 (11) vs. 1 (0.6);
back pain 11 (7) vs. 10 (6) vs. 1 (1);
dyspepsia 6 (4) vs. 8 (5) vs. 1 (0.6);
nasopharyngitis 8 (5) vs. 5 (3) vs. 5 (3);
nasal congestion 3 (2) vs. 6 (4) vs. 0;
upper respiratory tract infection 4 (3) vs.
5 (3) vs. 3 (2); myalgia 2 (1) vs. 5 (3) vs.
0; influenza 2(1) vs. 4 (3) vs. 3 (2).
SAE: n=3, 1 death in IG2; 2 (NR) in CG
Ascertainment of outcomes
assessed: SEP3: “Did your erection
last long enough for you to have
successful intercourse?” [yes/no]
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-134