I. Evista Fact File

Evista is manufactured by Lilly for the prevention and treatment of osteoporosis in women past menopause.

Eli Lilly and Company now enters its 126th year of business. The global, research-based company was founded in May 1876 by Colonel Eli Lilly in Indianapolis, Ind., in the Midwestern section of the United States.

Eli Lilly and Company is a leading, innovation-driven corporation, committed to developing a growing portfolio of best-in-class and first-in-class pharmaceutical products that help people live longer, healthier and more active lives.

Lilly products treat depression, schizophrenia, attention-deficit hyperactivity disorder, diabetes, osteoporosis and many other conditions.

II. Evista Medication

Evista medication (raloxifene HCl) is a prescription medication approved for the prevention and treatment of osteoporosis in women after menopause.

Osteoporosis: Information

Osteoporosis means porous bones. Bones affected by osteoporosis are less dense than normal bones. They are also more likely to break, even as a result of a minor bump or fall, or even without an injury. Osteoporosis has been called the "silent disease". Most people affected are unaware that their bones are thinning until they experience a break, or notice more gradual signs such as height loss, or curvature of the spine (sometimes known as "dowager's hump").

The bones most likely to break as a result of osteoporosis are the hip, wrist and the vertebrae of the spine.

Osteoporosis is a condition that causes thinning and weakening of normal bone. The definition of osteoporosis is a decrease of the density of bone mass. When this occurs, a patient with osteoporosis will have weaker bones and have a higher risk of bone fracture. Osteoporosis is not arthritis, which leads to problems within joints due to cartilage wear. Instead, osteoporosis is a problem of the bone, and its ability to adequately support the weight of your body.

What is Osteoporosis?
The inside of a bone consists of a strong mesh made of protein and minerals (particularly calcium). This mesh is living tissue that is constantly being renewed by a process called bone turnover. Old, worn out bone is broken down and absorbed by the body while, at the same time, new bone tissue is created from fresh protein and minerals.

Diagram 1

In children and young people, more new bone is created than is broken down. This makes bones bigger and denser.

The bones are at their strongest when the peak bone mass is reached, and this usually occurs in a person's mid-twenties. Peak bone mass is then maintained for about ten years, with roughly equal amounts of bone creation and breakdown. After the age of about 35, bone loss begins to overtake creation as part of the normal aging process. With osteoporosis, the process happens much more quickly, leading to premature bone weakness.

As well as bones, such as the wrist or hip, breaking more easily than usual, osteoporosis can result in small fractures of the bones in the spine. This can cause a curved back and a loss of height.

Diagram 2: Osteoporosis

There are two main categories of osteoporosis, Type I and Type II. Type I osteoporosis occurs only in post-menopausal women, and is due to estrogen deficiency. Type II osteoporosis occurs in both men and women (about two times more frequently in women), and is due to aging, and calcium deficiency over many years.

Osteoporosis can happen to any of your bones, but is most common in the hip, wrist, and in your spine, also called your vertebrae. Vertebrae are important because these bones support your body to stand and sit upright.

Osteoporosis in the vertebrae can cause serious problems for women. A fracture in this area occurs from day-to-day activities like climbing stairs, lifting objects, or bending forward:

• Sloping shoulders
• Curve in the back
• Height loss
• Back pain
• Hunched posture
• Protruding abdomen

Low levels of oestrogen
The female hormone oestrogen reduces the amount of bone that is broken down and so helps to protect against osteoporosis. In women, the ovaries make oestrogen from puberty to the menopause. Any condition that reduces the number of years that a woman produces oestrogen tends to increase the risk of osteoporosis.

These risks include:

• having an early menopause (before the age of 45),
• an early hysterectomy (before the age of 45, especially if both ovaries are removed),
• missing periods for six months or more as a result of over-exercising or over-dieting (especially due to anorexia)

Other risk factors of Osteoporosis :
Men who have low levels of the male hormone, testosterone, are also at a higher risk of osteoporosis. For both men and women, the following factors also increase the risk of developing osteoporosis:

• long-term use of corticosteroid tablets (medicines sometimes used for conditions such as severe allergies),
• a family history of broken hips,
• digestive disorders that affect absorption of nutrients, such as Crohn's disease or ulcerative colitis,
• long-term immobility,
• heavy drinking or smoking,
• very low body weight

Prevention of Osteoporosis

People who reach a high peak bone density when they are young are less likely to develop osteoporosis. Bone density can be boosted by a healthy diet and regular exercise, particularly in people under 35. This means prevention needs to begin at a young age.

i). Diet
A varied, well-balanced diet is important to build and maintain healthy bones. A combination of bread and cereals, fruit and vegetables, milk and diary products, and protein (from meat, fish, eggs, pulses, nuts and seeds) should provide the nutrients that your body needs.

Foods rich in calcium are especially valuable for healthy bones. Good sources include milk and diary products, such as cheese and yogurt.

The body needs vitamin D to absorb calcium properly. About 15-20 minutes of daylight on the face and arms during the summer months will enable the body to store enough vitamin D for the rest of the year; you don't need to sunbathe. Vitamin D is also available in foods such as margarine and oily fish.

ii). Exercise
Weight-bearing exercise helps to promote bone formation and bone health. Good exercises include running, skipping, aerobics, tennis, weight-training and brisk walking. Ideally, try to do this type of activity three times a week for at least 20 minutes.

If you are not used to exercising, build up your exercise routine gradually - increasing frequency before intensity. Talk to your doctor before you start if you have a health problem that affects your heart or breathing.

iii). Lifestyle
Smoking can have a harmful effect on bone and can also cause an early menopause. If you smoke, try to give up. You should also be careful not to drink too much alcohol.

Treatment for osteoporosis

There are now a number of effective treatments that can help prevent fractures and increase bone density. These include:

• Hormone replacement therapy (HRT): This prescription-only treatment aims to restore oestrogen to a pre-menopausal level. In the short term, it is taken to relieve menopausal symptoms such as hot flushes, night sweats, and vaginal dryness. In addition, other benefits of estrogen replacement in the postmenopausal patient include lower cholesterol, decreased risk of colon cancer, and fewer postmenopausal symptoms. Small doses over several years also reduce osteoporosis. HRT also helps reduce the risk of heart disease. Some women may experience breast tenderness and nausea as side-effects of the treatment. HRT can also increase the risk of developing breast cancer and uterine cancer, but the risk remains low.

There are over 30 forms of HRT available in pills, patches, under-the-skin implants or gels.

• Bisphosphonates are non-hormonal medicines, which work by blocking the break down of bone. There are three bisphosphonates available namely, alendronate (Fosamax), etidronate (Didronel) and risedronate (Actonel). Bone turnover, or replacement of old bone with new bone, is a normal process within our body. In patients with osteoporosis, the replacement with new bone does not maintain pace with the breakdown of old bone. Bisphosphanates slow the rate of bone breakdown to help maintain bone mass by inhibiting the osteoclast, the cell responsible for bone breakdown.
• Raloxifene is a newer medication that has been developed to provide some of the same advantages of estrogen (HRT), without the potential side-effects. A type of medicine called selective oestrogen-receptor modulator or SERM is a synthetic hormone replacement which works by copying the effects of oestrogen on the bones. This type of drug reduces the risk of osteoporosis and heart disease, but appears to not increase the risk of breast or endometrial cancers. The SERM currently available for osteoporosis is raloxifene (Evista). The effects of Raloxifene have been shown to be similar to estrogen, including an increase in bone mass and lower cholesterol. However, the SERMs do not have the same effects on the uterine lining, and therefore do not need to be combined with progesterone.
• Vitamin D and calcium supplements are an effective treatment to reduce bone loss in the elderly.
• Calcitriol is an active form of vitamin D given to post-menopausal women who have osteoporosis in the spine. Calcitriol improves the absorption of calcium from the gut.
• Calcitonin is a hormone made by the thyroid gland (a hormone-producing gland in the neck), which blocks the action of the cells that are responsible for breaking down bone. Calcitonin is a naturally occurring hormone produced by the thyroid gland that can be given as an injection or taken as a nasal spray. Sold under the trade name Miacalcin, calcitonin also inhibits the function of the cells that breakdown bone, the osteoclasts. Calcitonin has long been known to be beneficial in patients with osteoporosis, but the injections were difficult to administer, and had unpleasant side-effects. The nasal spray has greatly improved the use of calcitonin, and it is much more commonly used today. Calcitonin has been shown to slow bone loss, and also decrease pain associated with osteoporosis fractures.
• Testosterone can be used to treat men who are deficient in this hormone and can increase their bone density. It is available in injection or implant form.

Side effects of Osteoporosis Drugs

Aldendronate: Common side effects include constipation, diarrhea, indigestion, nausea, pain in the abdomen, and pain in the muscles and bones. These problems usually go away as the body adjusts to the medicine and do not need medical attention unless they continue or they interfere with normal activities.

Calcitonin: The most common side effects of calcitonin nasal spray are nose problems, such as dryness, redness, itching, sores, bleeding and general discomfort. These problems should go away as the body adjusts to the medicine, but if they do not or if they are very uncomfortable, check with a physician. Other side effects that should be brought to a physician's attention include headache, back pain and joint pain.

Injectable calcitonin may cause minor side effects such as nausea or vomiting; diarrhea; stomach pain; loss of appetite; flushing of the face, ears, hands or feet; and discomfort or redness at the place on the body where it is injected. Medical attention is not necessary unless these problems persist or cause unusual discomfort.

Anyone who has a skin rash or hives after taking injectable calcitonin should check with a physician as soon as possible.

Raloxifene : Common side effects include hot flashes, leg cramps, nausea and vomiting. Women who have these problems while taking raloxifene should check with their physicians.

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III. Useful links

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

http://www.mayoclinic.com/index.cfm

MedicineNet.com

Drugdigest.org

Healthsquare.com

Pharmacy sites

http://www.lilly.com

http://www.hsforum.com/stories/storyReader$1509 ,

http://www.hsforum.com/stories/storyReader$1516

http://www.hsforum.com/stories/storyReader$1504,

http://www.people.vcu.edu/~urdesai/atc.htm#Process%20of%20clotting

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