2011 THE AUTHORS; BJU INTERNATIONAL 2011 BJU INTERNATIONAL

Lower Urinary Tract

DUTASTERIDE VS. FINASTERIDE: EPICS

NICKEL

ET AL.

Comparison of dutasteride and finasteride for

treating benign prostatic hyperplasia: the
Enlarged Prostate International Comparator
BJUI BJU INTERNATIONAL
Study (EPICS)
J. Curtis Nickel, Peter Gilling*, Teuvo L. Tammela†, Betsy Morrill‡,
Timothy H. Wilson‡ and Roger S. Rittmaster‡
Department of Urology, Queen’s University Kingston, ON, Canada, *Department of Urology, Tauranga Hospital,
Tauranga, New Zealand, †Department of Urology, Tampere University Hospital and Medical School, Tampere, Finland,
and ‡GlaxoSmithKline, Research Triangle Park, NC, USA
Accepted for publication 20 January 2011

Study Type – Therapy (RCT)
Level of Evidence 1b
OBJECTIVE
• To assess the efficacy and safety of
dutasteride compared with finasteride in
treating men with symptomatic benign
prostatic hyperplasia (BPH) for 12
months.
PATIENTS AND METHODS
• The Enlarged Prostate International
Comparator Study was a multicentre,
randomized, double-blind, 12-month,
parallel-group study.
• Men aged ≥50 years with a clinical
diagnosis of BPH received once-daily
treatment with dutasteride 0.5 mg (n = 813)
or finasteride 5 mg (n = 817). After a 4-week
placebo run-in period, patients were
randomized to receive dutasteride or
finasteride for 48 weeks, followed by an
optional 24-month, open-label phase,
during which patients received dutasteride
0.5 mg once daily.
• The primary endpoint was change in
prostate volume, and the secondary
endpoints included improvement in
American Urological Association Symptom
Index (AUA-SI) scores, improvement in
What’s known on the subject? and What does the study add?
Both dutasteride and finasteride inhibit type 2 5α-reductase, the dominant form of 5α-
reductase in benign prostatic tissue, making these effective treatments for BPH. In
comparison with finasteride, dutasteride has a longer half-life and leads to a greater and
more consistent suppression of serum and intraprostatic DHT.
EPICS is currently the only prospective, randomized, double-blind study of finasteride vs
dutasteride for BPH endpoints conducted for longer than a few months. Over a one-year
period, treatment with dutasteride and finasteride led to similar reductions in prostate
volume, and improvements in peak urine flow and urinary symptoms associated with BPH
in men with an enlarged prostate. Men treated with finasteride and dutasteride also
experienced similar rates of adverse events over the course of one year, which suggests
that inhibition of both type 1 and type 2 5α-reductase, resulting in greater DHT
suppression than type 2 inhibition alone, does not confer an increase in adverse
events. Given the long-term, progressive nature of BPH, the one-year duration of EPICS
may limit the potential to observe major differences between dutasteride and finasteride
treatment.
maximum urinary flow rate (Qmax) and long- events were reported in the open-label
term safety in the 24-month open-label phase.
phase.
CONCLUSION
RESULTS
• Dutasteride and finasteride, when
• Both dutasteride and finasteride were administered for 12 months, were similarly
effective at reducing prostate volume with effective in reducing prostate volume and
no significant difference between the two improving Qmax and urinary symptoms
treatments during the study. associated with BPH in men with an
• Similar reductions in mean AUA-SI scores enlarged prostate.
and Qmax were also observed for men in both
treatment groups. KEYWORDS
• A similar percentage of adverse events
was experienced by patients of both benign prostatic hyperplasia, finasteride,
treatment groups, and no new adverse dutasteride, 5α-reductase inhibitors

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INTRODUCTION
Benign prostatic hyperplasia is a common
problem among ageing men. The prevalence
of BPH, based on histological evidence from
autopsy studies, is >50% in men aged 51–60
and 90% by the age 85 [1]. BPH clinically
manifests as LUTS associated with BOO,
incomplete bladder emptying and weak
stream and hesitancy, all of which affect a
man’s health-related quality of life [2,3]. In
more advanced cases, acute urinary retention
(AUR) can result, the risk of which increases
three-fold among men with enlarged
prostates (>30 mL) [4].
Dihydrotestosterone (DHT) is the primary
androgen responsible for the excessive
growth of the prostate that is characteristic of
BPH [5]. The conversion of testosterone to
DHT is blocked by 5α-reductase inhibitors
(5ARIs), which are used to treat BPH [6–8].
Dutasteride, a type 1 and type 2 5ARI, has
been shown to provide significantly greater
suppression of serum DHT than does
finasteride, a type 2 5ARI [9].
This study was designed to assess the efficacy
and safety of dutasteride 0.5 mg compared
with finasteride 5 mg for 12 months in
treating men with BPH, so as to meet the
requirements for registering dutasteride for
treating symptomatic BPH in countries in the
European Union. Prostate volume was
selected as the primary endpoint of this study
[10,11]. In an optional open-label extension
study, men from either treatment group
received dutasteride 0.5 mg for an additional
24 months. This optional extension of
dutasteride treatment provided an
opportunity to investigate the long-term
safety and tolerability of dutasteride
monotherapy. The Enlarged Prostate
International Comparator Study (EPICS)
began in 1998, and data from EPICS have
been published previously on the
GlaxoSmithKline online Clinical Study
Register (http://www.gsk-clinicalstudy
register.com). The safety data were published
in 2003 [12]. Efficacy data was published as
an abstract in the BJUI after presentation at
the Urological Society of Australia Annual
Scientific Meeting in Melbourne, Australia in
2005 [13]. In addition, efficacy data has been
published in several review articles including
those by Nickel 2004 [14], Keam and Scott
2008 [15] and Thomson 2005 [16]. As a result
of renewed interest within the medical
community in EPICS, the authors and
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DUTASTERIDE VS. FINASTERIDE: EPICS
GlaxoSmithKline decided to publish the
results in a primary peer-reviewed
manuscript. EPICS is the only prospective,
randomized, double-blind clinical comparison
of finasteride and dutasteride conducted over
a 12-month period, and it has not been
previously published as a primary research
paper.
PATIENTS AND METHODS
STUDY POPULATION
Men aged ≥50 years with a clinical diagnosis
of BPH according to medical history and
physical examination (including DRE) were
eligible for the study. Principal inclusion
criteria were an AUA Symptom Index (AUA-SI)
score ≥12 points at the screening visit,
prostate volume ≥30 cm3 assessed by TRUS,
two voids with maximum urinary flow rate
(Qmax) <15 mL/s and a minimum voided
volume of ≥125 mL. Principal exclusion
criteria included a post-void residual volume
>250 mL, a history or evidence of prostate
cancer, previous prostatic surgery or invasive
procedure to treat BPH, a history of AUR
within 3 months of study entry, and total
serum PSA < 1.5 ng/mL or >10.0 ng/mL.
Additional exclusion criteria related to
previous treatment included use of 5ARIs, use
of α-blockers within 2 weeks of the screening
visit and throughout the study, use of any α-
adrenergic agonists or anticholinergics or
cholinergics (within 48 h of all uroflowmetry
assessments), use of phytotherapy for BPH
within 4 weeks of the screening visit and
throughout the study, and concurrent use of
drugs with anti-androgenic properties or
anabolic steroids.
The study protocol was approved by a
national, regional or investigational centre
ethics committee or institutional review
board. Participants provided written informed
consent.
STUDY DESIGN
EPICS was a multicentre, randomized, double-
blind, double-dummy, 12-month parallel-
group study at 138 centres across Argentina,
Austria, Australia, Belgium, Brazil, Canada,
Czech Republic, Finland, Germany, Greece,
Hungary, Ireland, Israel, Italy, Mexico,
Netherlands, New Zealand, Norway, Portugal,
Russia, Singapore, Slovakia, South Africa,
Sweden, Taiwan, UK and Ukraine. Eligible
patients received once-daily treatment with
dutasteride 0.5 mg or finasteride 5 mg. After a
4-week placebo run-in period, patients were
randomized to receive dutasteride or
finasteride for 48 weeks, with scheduled clinic
visits at 3, 6, 9 and 12 months. This was
followed by an optional 24-month, open-label
phase, during which patients received
dutasteride 0.5 mg once daily with 10
scheduled clinic visits at 12 (final visit of
the double-blind phase), 15, 18, 21, 24, 27,
30, 33, 36 and 40 months post-
randomization. This study began in November
1998 and was completed in October 2000
(double-blind phase) and February 2003
(open phase).
Prostate volume was measured before and
after randomization at months 3 and 12.
The anteroposterior, cephalocaudal and
transverse dimensions of the prostate were
obtained by TRUS, and the prostate volume
was then calculated according to the formula:
π/6 (anteroposterior width × cephalocaudal
width × transverse width). Post-void residual
volume was measured by ultrasonography at
the screening visit, at baseline, and at months
3, 6 and 12. Symptom scores were assessed
using the AUA-SI; the questionnaire was self-
completed at the screening visit, at baseline
and at months 3, 6 and 12. Voided volume and
Qmax were assessed at the same time points.
PSA levels were measured at the screening
visit and at months 3 and 12; the blood
samples were taken before TRUS
measurements were made.
Safety-related assessments included the
reports of adverse events and serious adverse
events, laboratory assessments and PSA
measurements. During the open-label phase,
only safety data was collected.
STUDY ENDPOINTS AND STATISTICAL
ANALYSIS
At the preplanned 12-month analysis, the
primary endpoint was change in prostate
volume. Secondary endpoints included
improvement in AUA-SI scores, improvement
in Qmax and long-term safety in the 24-month
open-label phase. Investigators were
responsible for the detection and
documentation of adverse and serious adverse
events. After the opportunity to spontaneously
mention any problems, subjects were queried
for adverse events at each visit.
389
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The intent-to-treat (ITT) population consisted FIG. 1. Disposition of the men enrolled in EPICS.
of all men randomized to double-blind study
treatment. Change and percent change from Randomized
baseline prostate volume, and AUA-SI and n = 1630
Qmax change from baseline were calculated.
Missing values were accounted for using the
last observation carried forward. The sample Finasteride 5 mg Dutasteride 0.5 mg
size for the double-blind phase was based n = 817 n = 813
upon detecting a 5% difference with regard
to the percent change in prostate volume
Completed 12 Months Discontinued Completed 12 Months Discontinued
between dutasteride and finasteride at 12 n = 735 n = 82 n = 719 n = 94
months. The primary comparison was (90%) (10%) (88%) (12%)
dutasteride vs finasteride, for which the study
was powered at 90%, and superiority was
based on two-sided P values <0.05. At the Entered Entered
open-label open-label
time of study design, there was no precedence
n = 226 n = 222
for percent treatment change in prostate
volume using 5ARIs, although it was
perceived that finasteride treatment would Completed 36 Months Discontinued Completed 36 Months Discontinued
cause a 20% reduction from baseline prostate n = 183 n = 43 n = 188 n = 34
volume. Therefore, it was hypothesized that (81%) (19%) (85%) (15%)
dual inhibition by dutasteride would provide a
5% improvement over finasteride.

Analysis of the primary endpoint – percent
change in prostate volume – was conducted
using a log-transformed general linear model
with effects for treatment, investigative
centre geographical cluster and baseline
prostate volume. Similarly, adjusted mean
changes from baseline were also calculated
for AUA-SI and Qmax. All P values were
reported and there were no multiplicity
controls implemented.
The sample size of the open-label phase was
determined by the number of men who
completed the double-blind phase and
elected to enrol in the open-label phase. The
primary population for the open-label phase
was the open-label ITT population and
consisted of all men who were enrolled in the
open-label phase (after completing the 12-
month double-blind phase).
RESULTS
PATIENT DEMOGRAPHICS AND DISPOSITION
Of the 1630 men randomized (the ITT
population), 817 received finasteride
treatment and 813 received dutasteride
treatment (Fig. 1). Of these, 1454 completed
the month 12 visit (finasteride group, 735;
dutasteride group, 719). There was a similar
rate of discontinuation in the finasteride
group (10%) compared with the dutasteride
(12%) group (P = 0.34). Adverse events
were the main reason for discontinuation
(finasteride, 4%; dutasteride, 5%).
Eight countries (Brazil, Canada, Czech
Republic, Mexico, Norway, Portugal, Slovakia
and Ukraine) participated in the open-label
phase of the study. Of the men who
completed the double-blind phase, 226 men
(31%) from the finasteride group and 222
men (31%) from the dutasteride group
enrolled in the open-label phase (making a
total of 448 in the open-label ITT population).
Of these, 371 (83%) completed the month 36
visit, while 77 men (17%) discontinued before
this visit (Fig. 1). Adverse events were the
main reason for discontinuation (8%) in the
open-label phase.
Overall baseline demographics and patient
characteristics were similar across treatment
groups. Table 1 shows the patient baseline
characteristics.
PRIMARY ENDPOINT: REDUCTION IN
PROSTATE VOLUME
Both dutasteride and finasteride were
effective in reducing prostate volume, with no
significant difference between the two
treatments (Fig. 2). At month 3, there was an
adjusted mean percentage reduction in
prostate volume of 18.5% for men in the
finasteride group vs 18.3% in the dutasteride
group (P = 0.76). At month 12, the reduction
FIG. 2. Prostate volume percent change from
baseline in the double-blind study.
Month 3 Month 12
0
baseline in prostate volume, %
Adjusted mean change from
−5
−10
−15
−20 −18.5 −18.3
−25
−30 −26.7 −26.3
Finasteride (n = 788)
Dutasteride (n = 787)
was 26.7% in the finasteride group vs 26.3%
in the dutasteride group (P = 0.65). The
treatment difference at month 12 was 0.4%
(CI: 1.4–2.3%).
Patients in both treatment groups with
baseline prostate volumes ≥40 cm3 showed
slightly greater reductions in prostate volume
at month 12 compared with those with
baseline prostate volumes <40 cm3 (Table 2).
The percent reduction from baseline in
patients with a baseline prostate volume
≥40 cm3 was 27.7% in the finasteride group
and 27.6% in the dutasteride group (P = 0.90);
for patients with prostate volumes <40 cm3,
these reductions were 24.2% and 22.6% for
the finasteride and dutasteride groups,
respectively (P = 0.37).

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TABLE 1 Baseline characteristics of the ITT population in the double-blind and open-label phases of the study

Double-blind Open-label
Finasteride, Dutasteride, Total, Finasteride/Dutasteride*, Dutasteride/Dutasteride†,
Characteristic n = 817 n = 813 n = 448 n = 226 n = 222
Mean (SD) age, years 66.9 (7.37) 66.8 (7.18) 67.0 (7.28) 67.0 (7.21) 67.0 (7.36)
Race or ethnic group, n (%)
White 719 (88) 729 (90) 401 (90) 200 (88) 201 (91)
Black 13 (2) 8 (<1) 9 (2) 6 (3) 3 (1)
Asian 35 (4) 32 (4) 1 (<1) 0 (0) 1 (<1)
Hispanic 29 (4) 28 (3) 31 (7) 16 (7) 15 (7)
Other 21 (3) 16 (2) 6 (1) 4 (2) 2 (<1)
Mean (SD) AUA-SI score 16.5 (5.49) 16.7 (5.75) – – –
Mean (SD) Qmax, mL/s 10.0 (3.38) 10.1 (3.46) – – –
Mean (SD) PVR, mL 66.5 (61.78) 69.0 (63.55) – – –
Mean (SD) PSA, ng/mL 4.3 (2.16) 4.3 (2.26) – – –
Mean (SD) prostate volume mean, cm3 52.4 (19.37) 54.2 (21.90) – – –
Mean (SD) duration of BPH symptoms, years 4.3 (4.48) 4.4 (3.99) 4.3 (3.81) 4.4 (3.81) 4.3 (3.82)

*Subjects received finasteride during double-blind phase and dutasteride during open-label phase. †Subjects received dutasteride during both double-blind and
open-label phases of study.

TABLE 2 Percent change in prostate volume from baseline

Prostate volume <40 cm3 Prostate volume ≥40 cm3

Finasteride, n = 239 Dutasteride, n = 233 P Finasteride, n = 573 Dutasteride, n = 576 P
Month 3; n 229 223 552 556
Adjusted mean, % –16.6 –13.7 0.10 –19.4 –20.0 0.54
Month 12; n 230 226 558 561
Adjusted mean, % –24.2 –22.6 0.37 –27.7 –27.6 0.90

FIG. 3. AUA-SI score change from baseline in the FIG. 4. Qmax change from baseline in the double-blind In both treatment groups, PSA levels
double-blind study. Error bars indicate SE. study. Error bars indicate SE. consistently decreased from baseline to
months 3 and 12. From baseline, PSA levels in
Baseline Month 3 Month 6 Month 12 2.5 the finasteride group decreased by a mean of
0
2 2 38.9% at month 3 and 47.7% at month 12,
−1
Adjusted mean change from

Adjusted mean change from

2 while there was a mean decrease of 40.3% at

baseline in Qmax, mL/s

−2 1.6 month 3 and 49.5% at month 12 in the

baseline in AUA-SI

−3 dutasteride group.
−3.6 1.5 1.7
1.6
−4 −4.9 1.5 ADVERSE EVENTS IN THE DOUBLE-BLIND
−3.8
−5 −5.5 1 PHASE
−4.9
−6
−5.8 0.5 During the double-blind treatment phase of
−7
the study, 805 men (49%) experienced 1876
Finasteride (n = 795)
0 adverse events. A similar percentage of
Dutasteride (n = 795)
adverse events was experienced by patients of
Baseline Month 3 Month 6 Month 12
both treatment groups and, of all adverse
Finasteride (n = 789)
Dutasteride (n = 784)
events, none were reported in more than 10%
SECONDARY ENDPOINTS of men. Serious adverse events were reported
(P = 0.38; Fig. 3). Qmax at month 12 improved by 43 patients (5%) in the finasteride group
At month 12, the mean AUA-SI scores by 1.7 mL/s in the finasteride group and by and by 55 patients (7%) in the dutasteride
were reduced by 5.5 in the finasteride 2.0 mL/s in the dutasteride group (P = 0.14; group (Table 3). Drug-related adverse events
group and 5.8 in the dutasteride group Fig. 4). were reported by 161 patients (20%) in the

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TABLE 3 Adverse events in the double-blind study and open-label phase

Double-blind Open-label
Finasteride Dutasteride, Total, Finasteride/Dutasteride* Dutasteride/Dutasteride†
Type of AE n = 817 n = 813 n = 448 n = 226 n = 222
Any AE, n (%) 409 (50) 396 (49) 200 (45) 100 (44) 100 (45)
Serious AEs, n (%) 43 (5) 55 (7) 47 (10) 26 (12) 21 (9)
Drug-related AEs, n (%) 161 (20) 140 (17) 47 (10) 19 (8) 28 (13)
Drug-related AEs leading to study withdrawal, n (%) 16 (2) 8 (1) 13 (3) 7 (3) 6 (3)
AEs leading to study withdrawal, n (%) 35 (4) 38 (5) 32 (7) 20 (9) 12 (5)

*Subjects received finasteride during double-blind phase and dutasteride during open-label. †Subjects received dutasteride during both double-blind and open-
label phases of study. AE, adverse event.

TABLE 4 Adverse events of special interest during the double-blind or open-label phases of the study by year

Double-blind Open-label*
Finasteride Year 1, Dutasteride Year 1, Total, Finasteride/Dutasteride†, Dutasteride/Dutasteride‡,
Adverse event n = 817 n = 813 n = 448 Years 2 and 3 n = 226 Years 2 and 3 n = 222
Impotence, n (%) 74 (9) 63 (8) 14 (3) 6 (3) 8 (4)
Decreased libido, n (%) 50 (6) 41 (5) 5 (1) 5 (2) 0 (0)
Ejaculation disorders, n (%) 14 (2) 14 (2) 4 (<1) 1 (<1) 3 (1)
Sexual function disorders, n (%) 2 (<1) 1 (<1) 0 (0) 0 (0) 0 (0)
Gynaecomastia, n (%) 10 (1) 9 (1) 3 (<1) 2 (<1) 1 (<1)
Hypertension, n (%) 16 (2) 19 (2) 29 (6) 15 (7) 14 (6)
AUR, n (%) 11 (1) 16 (2) – – –
Prostate surgery§, n (%) 1 (<1) 2 (<1) – – –
Prostate cancer, n (%) 4 (<1) 3 (<1) 4 (<1) 3 (1) 1 (<1)

*Incidence of AUR and prostate surgery not specifically collected in the open-label phase. †Subjects received finasteride during double-blind phase and
dutasteride during open-label phase. ‡Subjects received dutasteride during both double-blind and open-label phases of study. §All subjects requiring surgery had
≥40 cm3 baseline prostate volumes.

finasteride group and by 140 (17%) in the
dutasteride group. The incidence of sexual
adverse events (impotence, decreased libido,
ejaculation disorders and sexual function
disorders), as well as gynaecomastia, was also
similar in each treatment group (Table 4).
Prostate cancer was reported in four men
from the finasteride group and three men in
the dutasteride group.
ADVERSE EVENTS IN THE OPEN-LABEL PHASE
In the open-label phase, in which all patients
received dutasteride, adverse events were
reported in 200 patients (45%) and serious
adverse events were reported in 47 patients
(10%; Table 3). Hypertension increased from
the first year (double-blind phase) to the
second and third years (open-label phase) of
the study, and was the most commonly
reported adverse event during the open-label
phase (Table 4). The incidence of new sexual
adverse events decreased over time. Four
subjects were diagnosed with prostate cancer,
including one subject who had previously
received dutasteride and three subjects who
had previously received finasteride.
DISCUSSION
Currently, EPICS is the only prospective,
randomized, double-blind study of finasteride
vs dutasteride for BPH endpoints conducted
for longer than a few months. In EPICS, both
dutasteride and finasteride treatment resulted
in similar reductions in prostate volume.
Mean AUA-SI scores improved from baseline
at months 3 and 12 in men in the dutasteride
and finasteride treatment groups. A notable
improvement in Qmax was observed within
both treatment groups from baseline, and no
statistically significant differences were
observed between the groups.
During the 12-month treatment period, there
were no differences in the overall numbers of
adverse events between the two treatment
groups. Once-daily treatment with
dutasteride 0.5 mg and finasteride 5 mg
resulted in an expected level of adverse events
related to sexual function, such as impotence,
decreased libido and ejaculation disorders. No
notable new adverse events appeared over
time.
Both dutasteride and finasteride inhibit type 2
5α-reductase, the dominant form of 5α-
reductase in benign prostatic tissue [17–19],
making them both effective treatments for

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BPH. Pharmacological characteristics of
dutasteride suggest the possibility of
improved outcomes with this treatment. In
comparison with finasteride, dutasteride has a
longer half-life (termination half-life of
approximately 5 weeks vs 6 h), which might
lead to better efficacy with dutasteride in
patients who take their medication irregularly
[20–22]. Dutasteride also leads to a greater
and more consistent suppression of serum
and intraprostatic DHT [9,23,24]. This study
found similar rates of adverse events and
sexual adverse events with dutasteride and
finasteride treatment. Therefore, inhibition of
both type 1 and type 2 5α-reductase,
resulting in greater DHT suppression than
type 2 inhibition alone, does not confer an
increase in adverse events [12].
Given the long-term, progressive nature of
BPH, the 1-year duration of EPICS may limit
the potential to observe major differences
between dutasteride and finasteride
treatment. As seen in clinical trials of up to 4
years’ duration, BPH symptoms and Qmax may
continue to improve over time after the
initiation of finasteride or dutasteride therapy
[25,26].
Another potential limitation of the present
study is the use of prostate volume as a
surrogate endpoint for AUR and BPH-related
surgery. Prostate volume may not fully
correlate with clinical efficacy. For example,
the Prospective European Doxazosin and
Combination Therapy and the Veterans Affairs
Cooperative studies showed no difference
between placebo and finasteride at 1 year
with respect to total IPSS and Qmax, despite
significant differences in prostate volume
change [27,28]. Finally, the open-label phase
of EPICS provides information on adverse
events experienced in men treated with
dutasteride for up to 3 years; however, in this
phase, patients were no longer blinded to
treatment and there was no group for
comparison. This limits comparisons that
might be made between the double-blind and
open-label phases of the study.
In conclusion, the present study suggests
that, when given for 1 year, dutasteride and
finasteride lead to similar reductions in
prostate volume, and improvements in Qmax
and urinary symptoms associated with BPH in
men with an enlarged prostate. Men treated
with finasteride and dutasteride also
experienced similar rates of adverse events
over the course of 1 year.
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ACKNOWLEDGEMENTS
EPICS was funded by GlaxoSmithKline.
Editorial support in the form of assistance
with the first draft, collating author
comments, assembly of tables and figures,
and editorial suggestions to draft versions of
this manuscript was provided by Brigitte
Teissedre, PhD of Choice Pharma and funded
by GlaxoSmithKline. Responsibility for
opinions, conclusions and interpretation of
data lies with the authors.
CONFLICT OF INTEREST
J. Curtis Nickel:
Astellas, consultant
Farr Labs, consultant
Triton and Trillium Therapeutics, consultant
GlaxoSmithKline, consultant/investigator
Johnson and Johnson, consultant/
investigator
Pfizer, consultant/investigator
Watson Biomedical, consultant/investigator
Ferring Pharmaceuticals, consultant/
investigator
Taris Biomedical, consultant/investigator
Peter Gilling:
Lumenis Inc., meeting participant and study
investigator
Teuvo L. Tammela:
Amgen, speaker, advisory board and study
investigator
Astellas, speaker and advisory board
AstraZeneca, speaker and study investigator
GlaxoSmithKline, advisory board, speaker and
study investigator
Orion Pharma, consultant
Betsy Morrill:
GlaxoSmithKline, employee
GlaxoSmithKline, equity ownership/stock
Timothy H. Wilson:
GlaxoSmithKline, employee
GlaxoSmithKline, equity ownership/stock
Roger S. Rittmaster:
GlaxoSmithKline, employee
GlaxoSmithKline, equity ownership/stock
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Available at: http://www.nejm.org/oloi/
full/10.1056/NEJM199608223350801
Correspondence: J. Curtis Nickel, Queen’s
University, Kingston General Hospital,
Department of Urology, 76 Stuart Street,
Kingston, ON K7L 2V7, Canada.
e-mail: jcn@queensu.ca
Abbreviations: EPICS, Enlarged Prostate
International Comparator Study; AUA-SI,
AUA Symptom Index; AUR, acute urinary
retention; DHT, dihydrotestosterone;
5ARI, 5α-reductase inhibitor; Qmax,
maximum urinary flow rate; ITT, intent-
to-treat.
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