Beste apotheek van Nederland

Author
Funding
N; study design; eligibility
Participants
characteristics
Diagnosis details Intervention Outcomes
Boulton (2001) 8
Funding
source: NR
N screened = NR
N randomized = 219
IG, n = 110
CG, n = 109
ITT analysis used for
primary outcome: NR
Inclusion: men 37 or older;
with diagnosed ED, and
stable type II DM (≥2 y;
HbA 1c <11%); also in stable
heterosexual relationship for
longer than 6 mo
Exclusion: genital
anatomical deformity; major
psychiatric disorder; hx of
alcoholism or substance
abuse; ED resulting from
SCI; MI, stroke, heart failure
or unstable angina within
previous 6 mo; hx of
hypotension; nitrate tx; type I
DM; HbA 1c ≥11%; recurrent
hypoglycemic episodes;
severe disabling autonomic
neuropathy; diabetes
secondary to pancreatic
damage; Cushing’s
syndrome; acromegaly
Age, mean
(range):
58 (range 38-80)
vs. 59 (45-72) y
Race (%):
White 96; Black 2
vs. 0; Asian 2;
other: 1 vs. 2
Co-morbidities,
%:
Hypertension
40 vs. 52;
Ischemic heart dx
6 v. 3;
hypercholesterole
mia 8 vs. 7
HbA 1c , median,
(range): 8.3 (5.1­
12.1)
Previous ED
treatment: NR
Smoking status
(%): smokers 22
vs. 24
Body weigh,
mean (range): 88
(60-146) kg
Concomitant
medications:
Insulin 32 vs. 37
Duration of ED,
mean (range): 4.6
(0.4-21) vs. 3.7 (0.7­
11)
Underlying
disease: DM
Psychogenic ED:
NR
Physiologic ED, %:
100
Mixed ED: NR
Other: duration of
DM, mean (range) =
10 (1-34) y
IG: sildenafil citrate
CG: placebo
IG:
Dose: 50 mg initially;
could adjust to 25 or
100 mg
Duration: 12 wk
Frequency: NR
Compliance: NR
CG:
Dose: placebo
Duration: 12 wk
Frequency: NR
Compliance: NR
Run In period: 4 wk
Wash out period: NA
F/u duration: 12 wk
Primary outcome results:
IIEF- Q3, mean (SEM): pre: 1.8; post
3.4 (0.2) vs. 1.9 (0.2)
IIEF- Q3, mean (SEM): pre: 1.5; post:
3.4 (0.2) vs. 1.8 (0.2)
IIEF- EF: pre: 10.4; post: 20.4 (1.2) vs.
11.5 (1.2)
Successful intercourse, %: pre 13.8;
post 58.8 vs. 14.4
GEQ, %: 65 vs. 11
Other outcomes assessed: life
satisfaction checklist; partner
questionnaire
Withdrawals/drop-outs/loss to f/u:
NR
WDAE, %: 0
TAE: 65 vs. 11; pts with AE= 38% vs.
6.4%; including headache 18.2 vs. 4;
flushing 15 vs. 0; dyspepsia 2 vs. 0.9;
abnormal vision 5 vs. 0
SAE: 0
Ascertainment of outcomes
assessed: IIEF, GEQ, life satisfaction
checklist
C-8