Objective: No reports have evaluated the treatment effects of tadalafil by age group in a positive, noninterventional observational study of Japanese men. The present study aimed to evaluate the treatment effects of tadalafil by age group in a positive, noninterventional observational study of Japanese men. We therefore divided patients into 2 groups about the age of 70 years and investigated the treatment effects of tadalafil regarding voiding and storage functions by age group. Methods: Changes from baseline in each parameter (International Prostate Symptom Score [IPSS], quality of life [QOL] score, Overactive Bladder Symptom Score [OABSS], and residual urine volume) at 4, 12, and 24 weeks after initiating tadalafil for benign prostatic hyperplasia (BPH) patients were compared between groups (50–69 years vs. ≥70 years). In addition, side effects of tadalafil were investigated by age group. Results: In the 50–69 years group, significant improvements from baseline were seen in IPSS total and QOL score for all time points. In addition, significant improvements in IPSS storage subscore from baseline were observed at the 4- and 24-week time points. In the ≥70 years group, significant improvements from baseline were seen in IPSS total, IPSS voiding and storage subscores, and QOL score at each time point. Conclusions: Tadalafil 5 mg once daily appeared effective in clinical settings for elderly BPH patients even over 70 years old.

1.
Berry
SJ
,
Coffey
DS
,
Walsh
PC
,
Ewing
LL
.
The development of human benign prostatic hyperplasia with age
.
J Urol
.
1984
;
132
:
474
9
. .
2.
Oesterling
JE
.
The origin and development of benign prostatic hyperplasia. An age-dependent process
.
J Androl
.
1991
;
12
:
348
55
.
3.
Terai
A
,
Kakehi
Y
,
Terachi
T
,
Ogawa
O
.
National trend of management of benign prostatic hyperplasia in Japan during 1990s: analysis of national health statistics
.
Acta Urol Jpn
.
2000
;
46
:
535
44
.
4.
Yoshida
M
,
Takeda
M
,
Takita
Y
,
Murakami
M
.
Tadalafil 5mg once daily for the treatment of Japanese men with lower urinary tract symptoms secondary to benign prostatic hyperplasia: analysis of data pooled from three randomized, double-blind, placebo control Asian studies
.
Jpn J Urol Surg
.
2015
;
28
(
11
):
1823
31
.
5.
Ozono
S
,
Kurita
Y
,
Kobayashi
T
.
Treatment and management of benign prostatic hyperplasia: health economics
.
Prog Med
.
2008
;
28
(
6
):
1419
23
.
6.
Morelli
A
,
Filippi
S
,
Comeglio
P
,
Sarchielli
E
,
Chavalmane
AK
,
Vignozzi
L
,
Acute vardenafil administration improves bladder oxygenation in spontaneously hypertensive rats
.
J Sex Med
.
2010
;
7
:
107
20
. .
7.
Morelli
A
,
Comeglio
P
,
Filippi
S
,
Sarchielli
E
,
Vignozzi
L
,
Maneschi
E
,
Mechanism of action of phosphodiesterase type 5 inhibition in metabolic syndrome-associated prostate alterations: an experimental study in the rabbit
.
Prostate
.
2013
;
73
:
428
41
. .
8.
Verit
A
,
Savas
M
,
Ciftci
H
,
Aksoy
N
,
Taskin
A
,
Topal
U
.
Assessment of the acute effects of tadalafil on the cardiovascular system based on examination of serum oxidative status and paraoxonase activity in men with erectile dysfunction: a preliminary study
.
Int J Impot Res
.
2010
;
22
:
115
9
. .
9.
Yoshida
M
,
Inadome
A
,
Murakami
S
.
[Pharmacological analysis of neurotransmitters contributing to lower urinary tract function]
.
Nihon Yakurigaku Zasshi
.
2003
;
121
:
307
16
. .
10.
Takeda
M
,
Tang
R
,
Shapiro
E
,
Burnett
AL
,
Lepor
H
.
Effects of nitric oxide on human and canine prostates
.
Urology
.
1995
;
45
:
440
6
. .
11.
Burnett
AL
,
Maguire
MP
,
Chamness
SL
,
Ricker
DD
,
Takeda
M
,
Lepor
H
,
Characterization and localization of nitric oxide synthase in the human prostate
.
Urology
.
1995
;
45
:
435
9
. .
12.
Chapple
CR
,
Roehrborn
CG
,
McVary
K
,
Ilo
D
,
Henneges
C
,
Viktrup
L
.
Effect of tadalafil on male lower urinary tract symptoms: an integrated analysis of storage and voiding international prostate symptom subscores from four randomized controlled trials
.
Eur Urol
.
2015
;
67
:
114
22
.
13.
Minagawa
T
,
Aizawa
N
,
Igawa
Y
,
Wyndaele
JJ
.
Inhibitory effects of phosphodiesterase 5 inhibitor, tadalafil, on mechanosensitive bladder afferent nerve activities of the rat, and on acrolein-induced hyperactivity of these nerves
.
BJU Int
.
2012
;
110
:
E259
66
. .
14.
Gratzke
C
,
Bachmann
A
,
Descazeaud
A
,
Drake
MJ
,
Madersbacher
S
,
Mamoulakis
C
,
EAU guidelines on the assessment of non-neurogenic male lower urinary tract symptoms including benign prostatic obstruction
.
Eur Urol
.
2015
;
67
(
6
):
1099
109
. .
15.
Oelke
M
,
Giuliano
F
,
Mirone
V
,
Xu
L
,
Cox
D
,
Viktrup
L
.
Monotherapy with tadalafil or tamsulosin similarly improved lower urinary tract symptoms suggestive of benign prostatic hyperplasia in an international, randomised, parallel, placebo-controlled clinical trial
.
Eur Urol
.
2012
;
61
:
917
25
. .
16.
Lee
E
,
Yoo
KY
,
Kim
Y
,
Shin
Y
,
Lee
C
.
Prevalence of lower urinary tract symptoms in Korean men in a community-based study
.
Eur Urol
.
1998
;
33
:
17
21
. .
17.
Tsukamoto
T
,
Kumamoto
Y
,
Masumori
N
,
Miyake
H
,
Rhodes
T
,
Girman
CJ
,
Prevalence of prostatism in Japanese men in a community-based study with comparison to a similar American study
.
J Urol
.
1995
;
154
:
391
5
. .
18.
Gacci
M
,
Corona
G
,
Salvi
M
,
Vignozzi
L
,
McVary
KT
,
Kaplan
SA
,
A systematic review and meta-analysis on the use of phosphodiesterase 5 inhibitors alone or in combination with α-blockers for lower urinary tract symptoms due to benign prostatic hyperplasia
.
Eur Urol
.
2012
;
61
(
5
):
994
1003
. .
19.
Yamaguchi
O
,
Nomiya
M
,
Andersson
KE
.
Functional consequences of chronic bladder ischemia
.
Neurourol Urodyn
.
2014
;
33
:
54
8
. .
20.
Ponholzer
A
,
Temml
C
,
Wehrberger
C
,
Marszalek
M
,
Madersbacher
S
.
The association between vascular risk factors and lower urinary tract symptoms in both sexes
.
Eur Urol
.
2006 Sep
;
50
(
3
):
581
6
. .
21.
Nagao
Y
,
Shimizu
S
,
Kurabayashi
A
,
Shimizu
T
,
Tsuda
M
,
Higashi
Y
,
Effects of silodosin and tadalafil on bladder dysfunction in spontaneously hypertensive rats: possible role of bladder blood flow
.
Int J Urol
.
2020 Mar
;
27
:
258
65
. .
22.
Amano
T
,
Earle
C
,
Imao
T
,
Matsumoto
Y
,
Kishikage
T
.
Administration of daily 5 mg tadalafil improves endothelial function in patients with benign prostatic hyperplasia
.
Aging Male
.
2017
;
22
:
1
6
.
23.
Fukumoto
K
,
Nagai
A
,
Hara
R
,
Fujii
T
,
Miyaji
Y
.
Tadalafil for male lower urinary tract symptoms improves endothelial function
.
Int J Urol
.
2017
;
24
:
206
10
. .
24.
Takahashi
R
,
Sumino
Y
,
Miyazato
M
,
Nishii
H
,
Oshiro
T
,
Mimata
H
,
Tadalafil improves nocturia and nocturia-related quality of life in patients with benign prostatic hyperplasia (KYU-PRO Study)
.
Urol Int
.
2020
;
104
:
587
93
. .
25.
Yamanishi
T
,
Kaga
K
,
Sakata
K
,
Yokoyama
T
,
Kageyama
S
,
Fuse
M
,
A randomized controlled study of the efficacy of tadalafil monotherapy versus combination of tadalafil and mirabegron for the treatment of persistent overactive bladder symptoms in men presenting with lower urinary tract symptoms (CONTACT Study)
.
Neurourol Urodyn
.
2020
;
39
:
804
12
. .
26.
Yamazaki
H
,
Tsujimoto
N
,
Koyanagi
M
,
Katoh
MC
,
Tajima
K
,
Komori
M
.
Real-world safety and effectiveness of tadalafil in patients with lower urinary tract symptoms secondary to benign prostatic hyperplasia: a Japanese post-marketing surveillance study
.
Pragmat Obs Res
.
2020
;
11
:
45
54
. .
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