|
|
| |
| Avodart™
(dutasteride) is indicated for the treatment of symptomatic
benign prostatic hyperplasia (BPH) in men with an enlarged
prostate to improve urinary symptoms, reduce risk of acute
urinary retention (AUR) and reduce the risk of the need
for BPH-related surgery.
Avodart,
a second-generation 5 alpha-reductase inhibitor (5 A-RI),
is the first and only medicine to inhibit both the type
1 and type 2 enzymes responsible for the conversion
of testosterone to DHT (dihydrotestosterone), the primary
cause of prostate growth. Avodart’s dual inhibition
decreases levels of DHT by 90 percent at two weeks and
93 percent at two years. By reducing DHT levels, Avodart
reduces the size of an enlarged prostate.
Avodart
will become available by prescription in the United
States in December 2002.
|
| |
| Avodart:
The First Dual-Acting 5 Alpha-Reductase Inhibitor for
BPH
Rationale
- BPH
is one of the most common health problems in older
men.1
- BPH
is a progressive condition in which the prostate gland
surrounding the urethra enlarges. As it grows, the
enlarged prostate obstructs the urethra, the tube
through which urine flows, causing urinary difficulties.
An enlarged prostate can continue to increase in size
and in severe cases lead to acute urinary retention
(AUR; a sudden and complete inability to urinate)
and the need for BPH-related surgery.1
- DHT
(dihydrotestosterone) is the male hormone primarily
responsible for the initial development and subsequent
enlargement of the prostate gland.
Benefits
- Avodart,
a second-generation 5 alpha-reductase inhibitor, is
the first and only medicine to inhibit both the type
1 and type 2 enzymes responsible for the conversion
of the male hormone testosterone to DHT.
- Avodart's
dual inhibition decreases levels of DHT by 90 percent
at two weeks and 93 percent at two years. By reducing
DHT levels, Avodart reduces the size of an enlarged
prostate.
- Avodart
also improves urinary symptoms and reduces the risk
of AUR and the need for BPH-related surgery, two potential
long-term serious consequences of BPH.
|
| |
| Clinical
Highlights
Avodart
was investigated in three large, well-controlled multi-center
studies involving 4,325 men aged 50 and above with a
serum PSA level = 1.5 ng/mL and < 10 ng/mL, and BPH
diagnosed by medical history and physical examination,
including enlarged prostate (greater than or equal to
30 cc) and BPH symptoms that were moderate to severe
according to the American Urological Association Symptom
Index.
Data
from these two-year clinical trials demonstrated that
treatment with Avodart (0.5 mg once daily) reduced the
risk of both AUR and BPH-related surgical intervention
relative to placebo, improved BPH-related symptoms,
decreased prostate volume, and increased maximum urinary
flow rates.
|
|
Click here to see
more important information
|
|
| |
|
|
| |
|
|
AVODART FACT
SHEET - PAGE 1
