I. Avodart Fact File
Avodart was launched by GlaxoSmithKline (GSK).
GlaxoSmithKline is a world-leading, research-based pharmaceutical company operating in more than 100 countries and employing more than 100,000 people worldwide. GlaxoSmithKline (GSK) is a world leading research-based pharmaceutical company with a powerful combination of skills and resources that provides a platform for delivering strong growth in today's rapidly changing healthcare environment. Headquartered in the UK and with operations based in the US, the new company is one of the industry leaders, with an estimated seven per cent of the world's pharmaceutical market.
GSK has more than 20 research and development (R&D) facilities around the world, with an annual R&D budget of around $7 billion and more than 16,000 people employed in R&D.
GSK also has leadership in four major therapeutic areas - anti-infectives, central nervous system (CNS), respiratory and gastro-intestinal/metabolic. In addition, it is a leader in the important area of vaccines and has a growing portfolio of oncology products.
GSK also has a Consumer Healthcare portfolio comprising over-the-counter (OTC) medicines, oral care products and nutritional healthcare drinks, all of which are among the market leaders.
GSK's R&D is based at 24 sites in seven countries. The company has a leading position in genomics/genetics and new drug discovery technologies. The GSK R&D budget is about £2.4bn/$4bn.
II. Avodart Medication
Avodart
medication is proven to improve symptoms
in men with Benign
Prostatic Hyperplasia (BPH)
and an enlarged prostate. Generic
Avodart is not a treatment for prostate cancer.
The benefits of Avodart medication are:
- Reduces the size of your prostate - not all
prostate
medicines can do that
- Reduces your risk of surgery for an enlarged prostate
- Reduces the risk of complications such as acute urinary retention (AUR)
- Over time, improves your bothersome urinary symptoms
Generic
Avodart works by lowering the production of the male
hormone that causes your prostate to enlarge. Just
as it took your prostate time to grow, it also
takes time for your prostate to shrink.
Generic
Avodart medication begins to shrink your prostate
in 1 month with a continued gradual reduction in prostate
size throughout the first 2 years of treatment and will
continue to hold your prostate to a smaller size.
If your prostate is smaller, it will put less pressure
on your urethra. Avodart
should provide symptom improvement after 3 to 6 months, and your
symptoms should continue to improve with prolonged usage. By shrinking
the prostate, Avodart
arrests the disease process of BPH.
Studies have shown that treatment with Avodart
for 2 years reduces the risk of acute urinary retention and/or the
risk of needing surgery for benign prostatic hyperplasia.
Not all prostate
medicines have been shown to reduce the risk of acute
urinary retention (AUR) and BPH-related
surgery.
Benign Prostatic Hyperplasia (BPH): Information
Diagram 1:
The prostate is one of the main components of
the male reproductive system and plays a vital role in the development
of the male sex organs. In adult men, its main function is to add
important fluids to the semen supplying nourishment to the sperm
during ejaculation. This protects the semen against naturally occurring
acids located within the vagina. In many men, the prostate
begins to grow when they are in their 50s and usually continues
to grow throughout the rest of their lives.
Benign prostatic hyperplasia (BPH),
also known as benign prostatic hypertrophy, is
a non-cancerous enlargement of the prostate, a
small gland that encircles the urethra in males and produces a fluid
that makes up part of semen. As the volume of the prostate
increases, it can put pressure on the urethra, causing a slowdown
in the urine stream, hesitancy in urinating, a frequent and urgent
need to urinate, and sometimes dribbling of urine at the end of
the flow. It can also cause urine retention, which can weaken the
bladder muscle and increase the risk of developing a urinary tract
infection (UTI) or kidney stones. In severe cases of BPH,
urine may back up into and damage the kidneys. Rarely, BPH
may prevent a patient from urinating at all, a situation that requires
immediate medical attention.
Benign prostatic hyperplasia (BPH) can also affect
sexual functioning. It can lead to reduced sexual ability, painful
orgasm, and impotence. The type and severity of
symptoms experienced will vary from person to person and may vary
over time. For many men, BPH
never progresses beyond a minor to moderate annoyance; for others,
it may represent a significant challenge to their quality of life.
Benign prostatic hyperplasia (BPH) becomes a very
common condition in men as they age. According to the American Urology
Association, about 50% of men will have some degree of BPH
by the time they are 60 years old, and up to 90% will be affected
by age 80. While BPH
does not cause prostate cancer, both may be found
together.
Diagram 2: Normal Prostate
Diagram 3: Enlarged Prostate
Causes of BPH
The cause of benign prostatic hyperplasia is unknown.
It is possible that the condition is associated with hormonal changes
that occur as men age. The testes produce the hormone testosterone,
which is converted to dihydrotestosterone (DHT) and estradiol (estrogen)
in certain tissues. High levels of dihydrotestosterone, a testosterone
derivative involved in prostate growth, may accumulate
and cause hyperplasia. How and why levels of DHT increase remains
a subject of research.
Signs and Symptoms of Benign prostatic hyperplasia (BPH)
Common symptoms of benign prostatic hyperplasia include the following:
- Blood in the urine (i.e., hematuria), caused by straining to void
- Dribbling after voiding
- Feeling that the bladder has not emptied completely after urination
- Frequent urination, particularly at night (i.e., nocturia)
- Hesitant, interrupted, or weak urine stream caused by decreased force
- Leakage of urine (i.e., overflow incontinence)
- Pushing or straining to begin urination
- Recurrent, sudden, urgent need to urinate
In severe cases of benign prostatic hyperplasia(BPH),
another symptom, acute urinary retention (the inability to urinate),
can result from holding urine for a long time, alcohol
consumption, long period of inactivity, cold temperatures,
allergy
or cold medications containing decongestants or antihistamines,
and some prescription drugs (e.g., ipratropium
bromide, albuterol, epinephrine). Any of these factors can prevent
the urinary sphincter from relaxing and allowing urine to flow out
of the bladder. Acute urinary retention causes severe pain and discomfort.
Catheterization may be necessary to drain urine from the bladder
and obtain relief.
Treatment of BPH
There are several treatment options for men with benign
prostate hyperplasia, depending on the severity of symptoms.
If symptoms do not threaten the man's health, he
may choose not to be treated. If symptoms are severe
enough to cause discomfort, interfere with daily activities, or
threaten health, treatment is usually recommended.
- Watchful waiting
Men with mild symptoms may choose to return for annual examinations. The physician will perform an examination that includes a DRE, PSA tests, and a urinary flow rate. The patient will be asked to describe symptoms in order to determine if the condition is worsening.
- Medication
5-Alpha reductase inhibitors such as finasteride (Proscar) and dutasteride (Avodart) prevent the conversion of testosterone to the hormone dihydrotestosterone (DHT). In many cases, a treatment period of 6-month is necessary to see if the therapy is going to work. These drugs are taken orally, once a day.
- Alpha blockers relax smooth muscle tissue in the bladder
neck and prostate, which increases urinary flow. They
typically are taken orally, once or twice a day.
Commonly prescribed alpha blockers include the following:
- alfuzosin (UroXatral), extended-release tablet taken once daily
- doxazosin (Cardura), tablet taken once daily
- prazosin (Minipress), capsule taken 2 or 3 times daily
- tamsulosin hydrochloride (Flomax), capsule taken once daily
- terazosin (Hytrin), capsule taken once daily
Patients taking an alpha blocker require follow-up during the first 3 or 4 weeks to evaluate the effect on symptoms and adjust the dosage, if necessary.
Although a prostatic stent is not a medical treatment, neither does it fall under the classification of a surgical procedure. Prostatic stents are used most often for patients with significant medical problems that prohibit medication or surgery. It is a tiny, spring-like device inserted into the urethra. When expanded, it pushes back the surrounding tissue and widens the urethra. Prostatic stents have several advantages:
- They can be placed in less than 15 minutes under regional anesthesia.
- Bleeding during and after surgery is minimal.
- The patient can be discharged the same day or the next morning.
There are also several disadvantages:
- Prepositioning can be difficult.
- They may cause irritation and frequent urination.
- They may cause pain or incontinence.
- Removing them (necessary in one-third of cases) can be difficult.
Side effects of BPH Medications
- Side effects of Proscar & Avodart include reduced libido, impotence, breast tenderness and enlargement, and reduced sperm count. Long-term risks and benefits have not been studied.
- Women who may be pregnant must avoid handling dutasteride capsules and broken or crushed finasteride tablets because exposure to the drugs may cause serious side effects to the fetus. Intact tablets are coated to prevent absorption through the skin during normal handling. Patients should wait at least 6 months after dutasteride treatment to donate blood to prevent pregnant women from being exposed to the drug through blood transfusion.
- Side effects of Alpha blockers include headache, dizziness, low blood pressure, fatigue, weakness, and difficulty breathing. Long-term risks and benefits have not been studied.
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III. Useful links
Government http://www.cdc.gov/
http://www.fda.gov/
http://www.fda.gov/cder/ogd/
http://www.nih.gov/
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi
http://www.health.gov.on.ca/
National Library of Medicine
World Health Organization
Health Sites
http://www.mayoclinic.com/index.cfm
MedicineNet.com
Drugdigest.org
Healthsquare.com
http://www.avodart.com
http://www.gsk.com/about/about.htm
http://www.labtestsonline.org/understanding/conditions/bph.html
http://www.urologychannel.com/prostate/bph/index.shtml
http://www.urologychannel.com/prostate/bph/treatment_med.shtml
Pharmacy sites
http://www.roche.com/home/company/com_hist.htm
http://www.healthdigest.org/Bactrim-DS(Oral)_2006_PRO.php
http://www.hsforum.com/stories/storyReader$1509
http://www.hsforum.com/stories/storyReader$1504
http://www.people.vcu.edu/~urdesai/atc.htm#Process%20of%20clotting
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