Long-Term (Over 10 Years) Evaluation of Efficacy and Safety of Finasteride in Japanese Men with Androgenetic Alopecia: Summary of Three Investigations

Abstract

Introduction: Finasteride has been the standard medical treatment for androgenetic alopecia (AGA) for over 20 years. We started AGA treatment with finasteride in 1999 in Japan, and have demonstrated 3 investigations as long-term and/or large-scale studies (3,177 cases in 2.5 years, 801 cases in 5 years, 532 cases in 10 years, respectively). The objective of this study is to summarize the three investigations, and to consider it as a base for future studies over the next 20 to 30 or more years.

Methods: Vertex photographs and/or forehead photographs were taken and recorded for every patient at each examination and used for evaluation for more than 20 years. Efficacy was assessed using the Norwood-Hamilton scale (N-H) and the modified global photographic assessment (MGPA) score, which is the standardized 7-point rating score using scalp photographs. Adverse reactions were assessed through self-reported evaluations by patients in two investigations

Results: All three of the investigations demonstrated high evaluations of improvement (MGPA≧5; 87.1%, 99.4%, and 91.5%, respectively), and higher evaluations of prevention of disease progression (MGPA≧4; 99.6%, 100%, and 99.1%, respectively). Furthermore, the early-stage AGA group (N-H I-III at first visit) and the younger group (less than 40 years of age at first visit) showed more improvement with long-term AGA treatment with finasteride than the other groups did. Two of the investigations showed safety of long-term AGA treatment with finasteride, revealing the low onset rates of adverse reactions (adverse reactions: 0.7% in 2.5 years and 6.8% in 10 years, respectively). Neither of the two investigations recognized Post Finasteride Syndrome adverse reaction at all.

Conclusion: Long-term (greater than 10 years) AGA treatment with finasteride 1 mg/day demonstrated a high efficacy and safety based on large-scale studies in Japanese men. For patients at the early stage of classification of AGA (within N-H I-III or earlier) and/or younger than 40 years of age, we recommend starting treatment with 1 mg/day finasteride.

Full text

130 Ju ly/A ug ust 2 022
HA IR TRA NSPLA NT FORU M INTER NATIONA L
Long-Term (Over 10 Years) Evaluation of Efcacy and Safety
of Finasteride in Japanese Men with Androgenetic Alopecia:
Summary of Three Investigations
Masayuki Yanagisawa, MD, PhD; Akio Sato MD, PhD I Tokyo, Japan I yanagisaw@hotmail.com
ABSTRACT
Introduction: Finasteride has been the standard medical treatment for androgenetic alopecia (AGA) for over 20 years. We
started AGA treatment with nasteride in 1999 in Japan, and have demonstrated 3 investigations as long-term and/or large-
scale studies (3,177 cases in 2.5 years, 801 cases in 5 years, 532 cases in 10 years, respectively). The objective of this study is to
summarize the three investigations, and to consider it as a base for future studies over the next 20 to 30 or more years.
Methods: Vertex photographs and/or forehead photographs were taken and recorded for every patient at each examination
and used for evaluation for more than 20 years. Efcacy was assessed using the Norwood-Hamilton scale (N-H) and the modied
global photographic assessment (MGPA) score, which is the standardized 7-point rating score using scalp photographs. Adverse
reactions were assessed through self-reported evaluations by patients in two investigations
Results: All three of the investigations demonstrated high evaluations of improvement (MGPA≧5; 87.1%, 99.4%, and 91.5%,
respectively), and higher evaluations of prevention of disease progression (MGPA≧4; 99.6%, 100%, and 99.1%, respectively).
Furthermore, the early-stage AGA group (N-H I-III at rst visit) and the younger group (less than 40 years of age at rst visit)
showed more improvement with long-term AGA treatment with nasteride than the other groups did. Two of the investigations
showed safety of long-term AGA treatment with nasteride, revealing the low onset rates of adverse reactions (adverse reactions:
0.7% in 2.5 years and 6.8% in 10 years, respectively). Neither of the two investigations recognized Post Finasteride Syndrome
adverse reaction at all.
Conclusion: Long-term (greater than 10 years) AGA treatment with nasteride 1mg/day demonstrated a high efcacy and safety
based on large-scale studies in Japanese men. For patients at the early stage of classication of AGA (within N-H I-III or earlier)
and/or younger than 40 years of age, we recommend starting treatment with 1mg/day nasteride.
Keywords: androgenetic alopecia, nasteride, Japanese, modied global photographic assessment score, Norwood-Hamilton scale
This article is open access and may not be copied, distributed, or modied without written permission from the International
Society of Hair Restoration Surgery.
INTRODUCTION
In 1997, U.S. Food and Drug Administration (FDA)
authorized the use of nasteride for the treatment of
androgenetic alopecia (AGA); subsequently, the treatment
was approved all over the world, and has been in use for
more than 20 years. Presently, nasteride is authorized in
over 60 countries and is administered to more than 3 million
patients for AGA. Dihydro-testosterone (DHT) has a key
role in mediating progressive scalp hair loss in men with
AGA, and nasteride blocks the conversion of testosterone
to DHT as a selective type II 5α-reductase inhibitor, which
justies its use in AGA treatment.1-3 Although nasteride
has been globally used for more than 20 years, only a few
investigations for up to 10 years have been demonstrated
worldwide.4, 5 The authors have previously demonstrated
three investigations of efcacy and safety of large-scale and
long-term AGA treatment with nasteride (3,177 cases in
2.5 years, 801 cases in 5 years, and 532 cases in 10 years,
respectively).5-7 The objective of this article is to summarize
the three investigations, and to consider them as a base for
future studies over the next 20 to 30 years or more.
METHODS
Tokyo Memorial Clinic (hereafter, “The clinic”) started
AGA treatment with nasteride in 1999 (the rst in Japan,
to our knowledge). Vertex photographs and/or forehead
photographs were taken and recorded for every patient
at each examination and used for evaluation for over 20
years (Figures 1 and 2). Efcacy was assessed using the
Norwood-Hamilton scale (N-H)8,9 and the modied global
photographic assessment (MGPA) score,10,11 which is the
standardized 7-point rating score using scalp photographs.
The study period for each of the three investigations is
as follows: The rst investigation, “Evaluation of Efcacy
and Safety of Finasteride 1mg in 3177 Japanese men with
Androgenetic Alopecia,” was evaluated from January 2006
to June 2009.7 The second investigation, “Five-Year Efcacy
of Finasteride in 801 Japanese Men with Androgenetic
Alopecia,” was evaluated from January 2000 to November
2008.6 The third investigation, “Long-Term (10-Year) Efcacy
FIGURE 1. Vertex photographs at the rst visit and yearly were evaluated using the
MGPA score and N-H scale.

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TABLE 2. Study Conclusions
Ø PAG E 132
of Finasteride in 523 Japanese Men with Androgenetic
Alopecia,” was evaluated from December 2005 to January
2009.5 The same patients were included in the three
investigations, but each study period was completely
different. In two of the investigations, adverse reactions
were assessed through self-reported evaluations by patients.
RESULTS
All three investigations demonstrated high evaluations
of improvement (MGPA ≧ 5; 87.1% (2230/2561), 99.4%
(796/801), and 91.5% (487/532), respectively), and higher
evaluations of prevention of disease progression (MGPA ≧
4; 99.6% (2550/2561), 100% (801/801), 99.1% (527/532),
respectively) (Tables 1 and 2). Furthermore, the early-stage
AGA group (N-H: I/II/III at rst visit) and the younger group
(less than 40 years of age at rst visit), demonstrated more
improvement with long-term AGA treatment with nasteride
than the other groups did.
In the investigation of “801 cases in 5 years,” receiver
operating characteristic (ROC) curve analysis was performed
to classify patients with sufcient efcacy (MGPA ≥6) and
insufcient (MGPA <6) condition at year 5 of treatment; the
cut-off point was N-H: IV, and 39 years at rst visit. (The
area under the curve [AUC], which indicates the predictive
value, was 0.676). In the investigation of “532 cases in 10
years,” ROC analysis was performed to classify patients with
improvement (MGPA ≥ 5) and no improvement (MGPA<5)
condition at year 10 of treatment; the cut-off point was N-H
III, and 39 years at rst visit (AUC was 0.746) (Table 3).
FIGURE 2. Forehead photographs (same patient from Figure 1) at the rst visit and
yearly were evaluated using the MGPA score and N-H scale.
TABLE 1. Study Improvement and Prevention Results
N‐H: Years
sufficient MGPA≧6
insufficient MGPA<6
improvement MGPA
≧
5
noimprovement MGPA<5
AreaUnder
theCurve
0.676
0.746
39
39
Cut‐offPoint
Comparison
801casesin5year
532casesin10year
IV
III
ReceiverOperatingCharacteristic
Curve(ROC)Analysis
TABLE 3. ROC Results
The two investigations demonstrated the safety of long-
term AGA treatment with nasteride, revealing the low onset
rates of adverse reactions (0.7% (23/3,177) in 2.5 years,
6.8% (36/532) in 10 years). All adverse reactions were mild
and almost all of the patients continued treatment for more
than 10 years. Neither of the two investigations recognized
Post Finasteride Syndrome adverse reaction at all.
DISCUSSION
The efcacy of the investigated treatment in Japanese
men exceeded that reported in other studies in Caucasians.
Differences have been known to occur in the progression of
AGA symptoms between Japanese and Caucasian men.7,1 2
The superior response of Japanese men with AGA was
reported to likely be attributable to their hair characteristics
(greater diameter, black color, and lower density), which
facilitated the detection of slight changes.6,13 -15
Though many investigations have been recognized all
over the world, most Japanese people still wrongly believe
the following: “nasteride has only efcacy of prevention
of AGA progression”; “nasteride decreases testosterone”;
“nasteride has serious adverse reactions (decreased libido,
male infertility, erectile dysfunction, liver dysfunction, etc.).”
The cause is thought to be because the package insert of
nasteride still includes the following wording: “Efcacy;
prevention of AGA progression”; in addition, there are
some noted adverse reactions without revision from 2006
in Japan. Possibly, a similar situation may happen in some
other countries. Some of our objectives in this study were to
dispel rumors and to publicize the true information.
Almost no Post Finasteride Syndrome has been recognized
as a result of AGA treatment with nasteride over the
20 years studied by our clinic. Similarly, almost no Post
Finasteride Syndrome as adverse reactions were recognized
from investigations of nasteride in Japan.5, 7,16
There are only a few articles that follow AGA treatment
with nasteride for 10 years.4,5 Furthermore, we have
continued investigating for greater than 10 years and are
preparing for future studies that detail 20, 30, or more years.
In summary, during the 3 investigations, long-term (greater
than 10 years) AGA treatment with nasteride 1mg/day
demonstrated high efcacy and safety based on large-scale
studies in Japanese men. For best efcacy, we recommend
that AGA patients should start treatment with 1mg/day
nasteride at the early stage of classication of AGA (N-H
I-III or earlier) and/or younger than 40 years of age.
References
1. Kaufman KD, Dawber RP. Finasteride, a Type 2 5alpha-reductase
inhibitor, in the treatment of men with androgenetic alopecia.
Expert Opin Investig Drugs. 1999; 8:403-415.
2.5years 3177 87.1% (2230/2561) 99.6% (2550/2561) 0.7% 233177
5years 801 99.4% (796/801) 100.0% (801/801)
10years 532 91.5% (487/532) 99.1% (527/532) 6.8% 36/532
noevaluation
AdverseReactions
Study
Population
StudyPeriod Improvement
(MGPAscore≥5)
Preventionof
DiseaseProgression
(MGPAscore≥4)
Conclusions
3177casesin2.5year InJapanesemenwithAGA,long‐termtreatmentwithfinasteride1mgtabletsmaintained
highefficacywithoutrecognizedside‐effect.
801casesin5year
Youngerageandlessadvanceddiseaseatstartoftreatmentwerethekeypredictors
ofhigherfinasterideefficacy.
Finasteridehaslowerefficacyinpatientsover40yearsoldandinpatientswith
advancedN‐Hscale(overN‐H:IV)atthefirstvisit.
532casesin10year
Long‐term (10‐year) AGA treatment with finasteride 1 mg/day demonstrated a high efficacy and
safetybasedonsubjectiveandobjectiveevaluationsinJapanesemen.
ThegroupwithN‐H:I/II/IIIatthefirstvisitshowedgreaterimprovementthanthegroup
withN‐H:IV/V/VI/VIIatfirstvisit,following10yearsofAGAtreatmentwithfinasteride.

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Ø CONTINUED FROM PAGE 131
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