GSK) announced that the U.S. Food and Drug Administration (FDA) has
approved AVODART (dutasteride) in combination with tamsulosin for the
treatment of symptomatic enlarged prostate, a disease that affects half of
all men over 50 years old. The new indication reflects emerging research
showing the combination of the two medicines treats the symptoms of
enlarged prostate more effectively than either medicine alone.
"The combination of AVODART and tamsulosin at diagnosis allows doctors
to simultaneously treat the patient's prostate on two fronts by reducing
prostate size and rapidly improving symptoms," said Steven A. Kaplan, M.D.,
from Weill Cornell Medical College of Cornell University in New York City.
Common symptoms of enlarged prostate include nocturia, frequent and
urgent urination, incomplete emptying, starting and stopping, and weak
stream. If left untreated, enlarged prostate can lead to hospitalization
for the inability to urinate or prostate surgery.
AVODART already had been approved by the FDA for the treatment of
enlarged prostate to improve urinary symptoms, reduce the risk of acute
urinary retention (AUR), and reduce the risk of prostate-related surgery.
Tamsulosin, an alpha-blocker, already had been indicated for the treatment
of the signs and symptoms of enlarged prostate.
The FDA approval was based on two-year results of the CombAT
(Combination of Avodart and Tamsulosin) study, one of the largest clinical
trials to date of men with enlarged prostate. The CombAT study is the first
long-term assessment of the combination of AVODART and an alpha-blocker.
Study results were first presented in September 2007 at the 29th annual
meeting of the Societe Internationale d'Urologie in Paris. The study was
published in the February issue of the Journal of Urology.
The CombAT study results showed that combination therapy with AVODART
and tamsulosin was superior to both monotherapies at Month 12 and continued
to Month 24. The primary endpoint was the change in International Prostate
Symptom Score (IPSS) from baseline at Month 24 for combination therapy
compared to each medication alone. The most common adverse reactions
reported in subjects receiving combination therapy were impotence,
decreased libido, breast disorders (including breast enlargement and
tenderness), ejaculation disorders, and dizziness.
Data from the remaining 2 years of the CombAT study will provide
further information on the pattern of symptoms and long-term outcomes
associated with combination therapy vs. AVODART and tamsulosin
monotherapies.
About CombAT
CombAT is a multicenter, randomized, double-blind and parallel-group
study. Men [aged greater than or equal to 50 years with a prostate volume
(PV) greater than or equal to 30 cc, serum prostate-specific antigen (PSA)
level 1.5-10 ng/mL, Qmax >5 and less than or equal to 15 mL/sec with a
minimum voided volume greater than or equal to 125 mL and International
Prostate Symptom Score (IPSS) greater than or equal to 12] with
moderate-to-severe enlarged prostate symptoms received placebo for four
weeks and were then randomized to receive AVODART 0.5 mg/day and tamsulosin
0.4 mg/day (n=1610), AVODART 0.5 mg/day (n=1623), or tamsulosin 0.4 mg/day
(n=1611).
ABOUT AVODART
AVODART, the first and only dual 5ARI for the treatment of enlarged
prostate, inhibits both the type I and type II isoenzymes responsible for
the conversion of testosterone into dihydrotestosterone (DHT). DHT is the
primary male hormone responsible for the enlargement of the prostate.
AVODART suppresses DHT by 93 percent at 2 years. AVODART is indicated for
the treatment of symptomatic enlarged prostate in men with an enlarged
prostate to improve symptoms, reduce the risk of acute urinary retention
(AUR), and reduce the risk of prostate-related surgery. AVODART is now
indicated in combination with the alpha blocker tamsulosin for the
treatment of symptomatic enlarged prostate. While some men have fewer
problems and symptoms after three months of treatment with AVODART, a
treatment period of at least six months is usually necessary to see if
AVODART will improve symptoms.
Only a healthcare provider can tell if symptoms are from an enlarged
prostate and not a more serious condition such as prostate cancer. Men
should see their doctors for regular exams. Children and women who are or
may become pregnant should not take AVODART. Women who are or may become
pregnant should not handle AVODART. Men treated with AVODART should not
donate blood until at least six months after their final dose.
Caution should be used in patients with liver disease. Possible side
effects include sexual side effects and breast tenderness and/or swelling.
These side effects occur infrequently. For full prescribing information,
see avodart.
About Enlarged Prostate
Enlarged prostate is a prevalent and progressive disease that affects
50 percent of men over 50 years of age and over 90 percent of men older
than age 80.1 An enlarged prostate causes changes in urinary habits because
of its location around the urethra. Over time, the prostate can continue to
grow and urinary symptoms may worsen as the bladder loses the ability to
empty itself. Left untreated, in severe cases, an enlarged prostate can
lead to serious long-term problems including acute urinary retention (AUR)
and the need for prostate-related surgery, and in rare cases even kidney or
bladder damage.
About GlaxoSmithKline
GlaxoSmithKline -- one of the world's leading research-based
pharmaceutical and healthcare companies -- is committed to improving the
quality of human life by enabling people to do more, feel better and live
longer.
-- The International Prostate Symptom Score (IPSS) is a symptom index
for enlarged prostate that was developed and validated by a
multidisciplinary measurement committee of the American Urological
Association (AUA). The symptom index includes questions covering
frequency, nocturia, weak urinary stream, hesitancy, intermittence,
incomplete emptying and urgency.
GlaxoSmithKline
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