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. 2017 Oct 31;6:1923. [Version 1] doi: 10.12688/f1000research.12066.1

Table 1. Randomised trials of oral phosphodiesterase type 5 inhibitors.

Authors Year Subjects Treatment Measure Duration Comment
Brock et al. 40 2003 440 Placebo versus
vardenafil 10 mg,
20 mg
IIEF-EF Diary
questions
Global Assessment
Question
3 months Benefit in severe erectile
dysfunction
Montorsi et al. 35 2008 628 Placebo versus
vardenafil (5 mg
to 20 mg); nightly
versus on-demand
IIEF 9 months,
2-month washout
On-demand better than nightly,
better than placebo
Padma-Nathan
et al. 41
2008 76 Placebo versus
nightly sildenafil
50 mg, 100 mg
IIEF 36 weeks,
8-week washout
Premature closing due to lack of
treatment effect. Results after
12 months of follow-up; 4%
of placebo patients regained
spontaneous erection compared
with 27% in treatment arm
Mulhall et al. 42 2013 298 Avanafil on-demand
versus placebo
Sexual encounter
profile (question 2)
Sexual intercourse
IIEF-EF
3 months
Pavlovich et al. 36 2013 100 Sildenafil; on-demand
with nightly placebo
versus nightly with
on-demand placebo
Quality-of-life
assessments
12 months,
1-month
washout
No significant differences found.
No sole placebo group
Montorsi et al. 37 2014 423 Placebo versus
tadalafil; daily versus
on-demand
IIEF-EF
Sexual encounter profile
Penile length
9 months,
6-week washout,
3-month open-
label
Penile length loss reduced by
4.1 mm
Unassisted erectile function not
improved after treatment cessation.
No benefit to tadalafil versus
placebo
Moncada et al. 38 2015 423 Placebo versus
tadalafil; daily versus
on-demand
IIEF-EF 9 months,
6-week washout
IIEF-EF improved most with daily
(29.5%, 23.9%,18.4% with IIEF ≥22)
Kim et al. 39 2016 74 On-demand sildenafil
with addition of
either nightly
sildenafil or placebo
Rigiscan/IIEF 12 months,
1-month
washout
No benefit of additional nightly
dosing to on-demand. No pure
placebo group

IIEF, International Index of Erectile Function; IIEF-EF, International Index of Erectile Function–erectile function domain.