Beste apotheek van Nederland

C-127
Author
Funding
N; study design; eligibility
Participants
characteristics
Diagnosis details Intervention Outcomes
Sáenz de
TeJada (2002)
138
Funding
source: Lilly
ICOS LLC
N screened = NR
N randomized = 216
IG1, n = 73
IG2, n = 72
CG, n = 71
ITT analysis used for
primary outcome: yes
Inclusion: men 18 or older;
clinical diagnosis of type 1 or
2 DM; mild to severe ED for
≥3 mo; in stable
monogamous relationship
with female partner
Exclusion: pts with HbA1C
> 13%recent hx of diabetic
ketoacidosis; hypoglycaemia
requiting assistance; angina
during intercourse, unstable
angina, dx of coronary artery
dx, poorly controlled BP(for
complete list of exclusion
criteria refer to full text)
Age, mean (sd):
55.7 (9) y
Race, n (%):
White 215 (99.5);
Black 1 (0.5)
Co-morbidities, n
(%): type I
diabetes IG1 =
CG 8 (11.3) vs.
IG2 4 (5.6); type II
DM 65 (89) vs. 68
(94.4) vs. 63
(88.7)
Hypertension 80
(37);
hypercholesterole
mia 38 (18);
micro-vascular
complications in
all grps 48 (22.2)
Previous ED
treatment: NR
Smoking status:
NR
Body weight: NR
Concomitant
medications, (%):
insulin only 36 vs. 28
vs. 45; oral only 44
vs. 54 vs. 41; mix 12
vs. 8 vs. 10
Duration of ED, n
(%): > 1y: 201 (93)
Underlying
disease: diabetes;
hypertension
Psychogenic ED:
NR
Physiologic ED: all
Mixed ED: NR
Other: IIEF score
overall, mean (sd)=
12.2 (6.2)
Other: subgroup
defined based on
HbA1C levels: poor
(>9.5%)= 40 (18.5),
fair (7-9.5%)= 136
(63), good (<7%)=
40 (18.5)
IG1: Tadalafil oral
CG: placebo oral
IG1:
Dose: 10 (IG1) or 20
(IG2) mg
Duration: 12 wk
Frequency: 1 dose
before anticipated
sexual activity; max. 1/d
Compliance: NR
CG:
Dose: placebo
Duration: 12 wk
Frequency: 1 dose
before anticipated
sexual activity; max. 1/d
Compliance: NR
Run In period: 4 wk
Wash out period: NA
F/u duration: 13-14 wk
Primary outcome results:
IG1 vs. IG2 vs. CG
Change (▲) in mean EF domain of
IIEF: 6.4, vs. 7.3 vs. 0.1
(% of pts with more than 5 positive
points in IIEF EF domain: 44% vs. 56%
vs. 13%, p <0.001)
Change (▲) in mean % of “yes”
response:
SEP-Q2: 22 vs. 23 vs. - 4.1
SEP-Q3: 28 vs. 29 vs. 2
GAQ, proportion of positive responses,
(%): 56 vs. 64 vs. 25, p < 0.001
Other outcomes assessed:
IIEFQ 3 and 4; OS, and OF (all sign
post tx, values NR)
Withdrawals/drop-outs/loss to f/u: 25
WDAE: 6 (3%); 5 in IG and 1 in CG; 2
MI one in each grp; moderate myalgia,
pain, headache & flushing
TAE, n (%): AE in > 3% of pts= 29 (40)
vs. 32 (44) vs. 22 (31); dyspepsia 8 (11)
vs. 8 (11) vs. 0; headache 9 (10) vs. 6
(8) vs. 2 (3), myalgia 4 (6) vs. 3 (4) vs. 1
(1), flu symptoms, IG=CG 3(4), back
pain 1 (1) vs. 4 (6) vs. 1 (1), flushing 2
(3) vs. 3 (4) vs. 0
SAE: 2 (MI) (1 in either grp; however,
patient in IG1 never took study drug)
Ascertainment of outcomes
assessed: IIEF, SEP, GAQ