HRT ppt

HORMONE REPLACEMENT THERAPY: 

HORMONE REPLACEMENT THERAPY Presented by Damodhar P. Donadkar

Contents: 

Contents Introduction Hormonal diseases Pathophysiology and management Marketing and revenue

1.Introduction: 

1.Introduction Hormone replacement therapy ( HRT ) is a system of medical treatment for surgically menopausal, perimenopausal and to a lesser extent postmenopausal women. It is based on the idea that the treatment may prevent discomfort caused by diminished circulating  estrogen and progesterone hormones, or in the case of the surgically or prematurely menopausal, that it may prolong life and may reduce incidence of dementia. It involves the use of one or more of a group of medications designed to artificially boost hormone levels. The main types of hormones involved are estrogens, progesterone or progestins, and sometimes testosterone.

Slide 4: 

Hormone replacement therapy or HRT is one of the treatments offered by medicine for the physical and psychological ailments of menopausal women. HRT is a clinical alternative offered by doctors to women whose estrogen levels are either very low or non-existent; a process that happens either because of natural or surgical menopause. HRT replaces the body's decreasing estrogen and can often provide relief for many symptoms. Used over a long period of time, HRT is also believed to act as a preventive against some diseases.

Slide 5: 

There are two categories of usage recommended for HRT. One is short-term use for relief of symptoms caused by lowered estrogen. The effectiveness and validity of short-term HRT therapy is not generally disputed. The long-term therapy can extend for a period of five to ten years or even be lifelong. Physicians recommend long-term use of HRT as part of preventive care for older women against diseases like osteoporosis, heart disease and Alzheimer's disease. The therapy does have its side effects as well as strong contraindications for use.

importance: 

importance Hormone replacement therapy is one of the most commonly prescribed treatments in the United States. Because of the decrease in estrogen that occurs with menopause, a woman's risk for heart disease begins to increase toward that of a man's. Hormone replacement therapy may reduce this risk in some women. Hormone replacement therapy can help protect women against osteoporosis, a disease that weakens bones.

Slide 7: 

A number of other drugs are available that can help the discomforts of menopause and provide protection against certain diseases that can occur as a result of lower estrogen production. Hormone replacement therapies available as tablets, implants, skin patches, and creams. The decision on whether to take HRT is a personal one. What is best for one woman may not be best for another.

Slide 8: 

HRT risks and possible side effects include : Increased risk of endometrial cancer in women with a uterus if estrogen is taken without progesterone or a progestin Slightly increased risk of breast cancer after 4 or more years of HRT, as shown in the WHI study that used continuous combined oral estrogen and progestin (Prempro). Estrogen alone or other HRT regimens may not raise the risk of breast cancer significantly. Increased breast density, making mammograms more difficult to interpret and possibly increasing breast cancer risk. This appears to be an effect primarily associated with taking oral progestin continuously with estrogen (e.g., Prempro). Slightly increased risk of ovarian cancer Slightly increased risk of blood clots, associated primarily with oral estrogens such as Premarin*

Hormone: 

Hormone . A regulatory substance produced in an organism and transported in tissue fluids such as blood or sap to stimulate specific cells or tissues into action. is a chemical messenger that carries a signal from one cell (or group of cells) to another. All multicellular organisms produce hormones. The function of hormones is to carry information to the target cells. vital for every process which is carried in our body be it digestion, growth, metabolism, stress control, mood swings, reproduction, menstruation etc.

List of hormones: 

List of hormones Estrogen Progesterone Testosterone Thyroxine(T4) Triiodothyronine(T3) Insulin

2.Diseases due to hormonal imbalances: 

2.Diseases due to hormonal imbalances Cancer Autoimmune Diseases Cushing’s syndrome Acromegaly Hypothyroidism Andropause Monopause

Andropause: 

Andropause Definition & Symptoms: Andropause describes an emotional and physical change that many men experience as they age. The most common symptoms are low sex drive, low energy level, and loss of strength and muscle mass. Although the symptoms are generally related to aging, they are also associated with significant hormonal alterations The condition has several names including male climacteric andropause, late onset hypogonadism, or androgen decline in the aging male.

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Incidence: Andropause is a fairly common condition and the incidence of it increases with age. Ages 40-49 2 – 5% 50-59 6 – 30% 60-69 20 - 45% 70-79 34 – 70% Over 90 91% The "spread" of normal ranges is fairly large because different specialists use different ways to measure androgens and use different levels to define andropause .

Slide 14: 

Testosterone Replacement Therapy Therapy for andropause is often very effective. Treatment goals include restoration of sexual functioning, increased libido, increased sense of well-being, prevention of osteoporosis by optimizing bone density, restoration of muscle strength, and improved mental functioning. Biochemically, testosterone replacement should aim not only to reach normal levels of serum testosterone, but also to normalize levels of those secondary hormones that are affected by testosterone levels. These include DHT and estradiol.

Slide 15: 

Current treatment options include oral tablets or capsules, injections, plantable long-acting slow release pellets, and transdermal (through the skin) patches and gels. However, at this point, the vast majority of testosterone replacement is done through the skin. This method has a number of advantages:

Menopause: 

Menopause Leads woman’s body to slow down the production of estrogen by the ovaries. Menopause occurs between the ages 45-55. In other parts of the world there is no equivalent of the word “menopause”.

What is Menopause?: 

What is Menopause? A baby girl comes into the world with 2 million eggs. By age 12, the count is down to 300,000 eggs. By her late 30’s, the count has fallen to 25,000. By middle-age, the ovaries are eggless.

The Unspoken Side Effects: 

The Unspoken Side Effects Hormone output has decreased significantly. The reduction of estrogen in a women’s body has wide ranging effects including: Night sweats. Fatigue, irritability and mood changes. Increased risk of Osteoporosis. Hot flash

HRT: 

HRT HRT has been used since the 1940s. Short term use: Used to treat symptoms associated with menopause by estrogen therapy. Long term use: Often prescribed to prevent osteoporosis, hip fractures, and colon cancer, and heart disease. Pill or tablet, vaginal creams, vaginal ring insert, implants. estrogen patch is a delivery system for estradiol , treat the problems of menopause

Breast Cancer: 

Breast Cancer What is Cancer? Cancer involves the abnormal multiplication and spread of cells in the body. It is usually caused by mutations in somatic cell genes that regulate cell growth. Almost every tissue in the body can produce cancer; some even generate many different types of cancer. However, cancer mostly occurs in cells that divide and reproduce more than other cells.

Diagram of the Breast: 

Diagram of the Breast The breast is a glandular organ. It is made up of a network of mammary ducts. Each breast has about 15-20 mammary ducts that lead to lobes that are made up of lobules. The lobules contain cells that secrete milk that are stimulated by estrogen and progesterone which are ovarian hormones . http://cancernet.nci.nih.gov/wyntk_pubs/breast.htm#2

Breast Cancer: 

Breast Cancer Breast Cancer occurs when a mutation takes place in the cells that line the lobules that manufacture milk or more commonly in the ducts that carry it to the nipple. The area around the center of the breast is where most cancers occur. It is fairly rare for cancers to form in the fat or non-glandular tissues of the breast.

Slide 23: 

Breast cancer hormone therapy Doctors say these cancers are either estrogen receptor positive or progesterone receptor positive, or both. Hormone treatment for breast cancer works by stopping these hormones getting to the breast cancer cells. There are different types of hormone therapies that doctors use to treat breast cancer Tamoxifen Aromatase inhibitors Pituitary down regulators

Slide 24: 

Tamoxifen Tamoxifen is one of the most common hormone therapies used for breast cancer. Both pre and postmenopausal women can take tamoxifen. It works by stopping the hormone estrogen from reaching cancer cells Aromatase inhibitors These are a relatively new type of hormone therapy. You can only take them if you have been through the menopause. After menopause, your ovaries stop producing estrogen. But your body still makes a small amount by changing other hormones (called androgens) into estrogen. You need an enzyme called aromatase to make this change happen. Aromatase inhibitors block this enzyme so it can’t convert androgen into estrogen.

Slide 25: 

There are a few different types of aromatase inhibitor, including Anastrozole (Arimidex®) Exemestane (Aromasin®) Letrozole (Femara®)

Hypothyroidsm: 

Hypothyroidsm Defnition : Biochemical and physiologic complex when inadequate serum levels of thyroid hormone are present both much more common in women P revalence of hypothyroidism with age BDA – 0.5-2% of women between 18-60 – 4-5% of European and American women over 60 years Lifetime prevalence of thyrotoxicosis is less common than hypothyroidism – ~0.5-2% European women over 60 years

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Treatment of hypothyroidism Treat with levothyroxine Typical replacement dosage ~100 to 125 micrograms daily for women ~125-150 micrograms daily for men ~1.5-2.0 microgram per kilogram of body weight daily

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Treatment of hypothyroidism Initial therapy Start at low dosage (25-50 micrograms daily) with frail, elderly patients or in patients with heart disease Start at the estimated full dosage for younger, healthier patients Check TSH in 4-6 weeks Adjustment of dosage, Wait 6 weeks after change of dosage before rechecking TSH and adjusting dosage

Drugs used in HRT: 

Drugs used in HRT Activella Androgel Angeliq Cenestin Climara Combipatch Enjuvia Estrace Estraderm Estradiol Estratab Estrogel Estropipate Evamist Femhrt Femring Menest Natural Estrogenic Substance- estrone Premarin Prempro Progesterone Prometrium Testim Testosterone Cypionate Vivelle Vivelle -dot

Activella: 

Activella Activella is a prescription hormone replacement medication. It contains estrogen and progesterone -- hormones that can help relieve menopausal symptoms and prevent menopause-related bone changes. The medication comes in tablet form and is generally taken once a day. While most women tolerate it well, potential side effects include breast pain, vaginal bleeding, and upper respiratory tract infection . The pharmaceutical industry earns revenue of over $100 billion ...

Prempro: 

Prempro Prempro brings almost $1.4 billion in revenue to Wyeth , the drug company that manufactures and promotes the use of Prempro . "PREMPRO is not for every woman. It should not be taken if you have had heart disease; unusual vaginal bleeding or a hysterectomy; certain types of cancer; blood clots; liver disease; stroke; if you think or know you are pregnant . PREMPRO contains progestin, which may have unfavorable effects on blood sugars and may worsen a diabetic condition . While estrogen can increase the risk of cancer of the uterus, the addition of progestin, as in PREMPRO, reduces this risk." Wyeth’s coffer each year. Side effects with PREMPRO may include blood clots, nausea, abdominal pain, breast tenderness, irregular bleeding, headache, and hair loss..

Marketing and revenue: 

Marketing and revenue Abbott Berlex Eli Lilly Forest Galen Genentech King Mylan Novartis Pfizer Serono Wyeth

Slide 33: 

Bayer HealthCare Pharmaceuticals is a research-based pharmaceutical company headquartered in Leverkusen , Germany . In 2004 Bayer HealthCare Pharmaceuticals recorded US sales of $ 1.3 billion. Antares Pharma Reports Total revenues increased to $7.9 million for 2007, an increase of 84% over 2006. Net cash used in operations for 2007 was $5.4 million, compared to $6.1 million in 2006. At December 31, 2007, Antares had approximately $26.1 million in cash, cash equivalents and short-term investments.

Treatment cost: 

Treatment cost Short-term HRT has a higher acceptance and compliance from Indian women. Short-term use has been found to be effective in cases of burning sensation while urinating, hot flashes, vaginal dryness, incontinence, insomnia, dizziness; collectively known as vasomotor symptoms that appear and disappear in the early stages of menopause. The cheapest tablet available in India is Estriol. The cost of a 2mg tablet is Rs 3. The usual dosage is two tablets per day and the course is for three months. Thus per course the user spends Rs 540.

Slide 35: 

Success is usually assured but often the course needs to be repeated frequently over a period of two years. The latest HRT prescription, a pill called Infar, is more convenient to use since it has to be taken only once a day. Its drawback so far is that one month's treatment costs Rs 1000. that works out to more than Rs 30 per pill - well beyond the reach of the average Indian woman. At least one physician puts the price tag at about $1,000 per person per year for treatment and monitoring.

Slide 36: 

Views on HRT A study of 500 women undertaken by the Institute for Research in Reproduction (IRR), India showed that only 40.1 percent agreed to take short-term therapy for up to one year. With regard to long-term therapy for more than five years, 67.8 percent refused the HRT. Among the common reasons for refusal were nuisance of vaginal bleeding and a feeling that menopause was a natural occurrence and needed no treatment. Lack of awareness was also a reason for low usage. Of the 156 women who agreed to use it on a long-term basis, 55.1 percent were willing to take it provided the per month cost was between Rs 50-100 (current costs are in the range of Rs 200 per month).

Slide 37: 

HRT and the Indian scene HRT is not commonly prescribed in India for two reasons : One is the expense and the other is a mindset that argues against interfering with a natural stage . Before discussing HRT, it must be noted that this therapy in India is almost exclusively in the domain of private medical practice . Even within this, it is estimated that only about one percent of post-menopausal urban women is on HRT. Nevertheless, there is a growing tendency in India to medicalise menopause .

Slide 38: 

This tendency is attributed to three reasons: the break-up of traditional social backup systems that helped women to adapt to this phase of life. the increasing life spans of Indian women, resulting in women living a quarter to a third of their lives in a post-menopausal state - the life expectancy of Indian women is 61.4 years. a growing population, and especially a growing urban middle class ( presently the Indian middle class numbers 200 million according to the Statistical Outline of India published by Department of Economics and Statistics, Tata Services Ltd. ) Means that HRT manufacturers will ultimately see India as a potential market.

Slide 39: 

There are indications that HRT manufacturers are interested in the Indian market. In a paper entitled ` The Menopause and HRT: Growing Public Health Challenges ' Dr Rashmi Shah stated, "76 percent of the world's post menopausal women will be in developing countries." Indian activists express the fear that western corporations are showing an interest in the growing youth consciousness of Indian women. So far, HRT advertising (a fairly accurate indicator of an industry's interest in a market) in India has been restricted to medical journals.

Slide 40: 

Supporting HRT in INDIA An 83-year-old gynaecologist who chose HRT for herself. In fact she is probably the oldest HRT user in the country having been on the treatment for more than 30 years . She reports absolutely no negative effects from her two pills per day dosage.

Slide 41: 

Currently, men and women in India in the 60 plus age group number about 60 million; that's about six percent of the population. Projections for the year 2025 show that this is expected to increase to approximately 165 million. Thus, in the space of 30 years the ageing population is expected to increase to the extent where more than 12 percent of the population will be age 60 or older. Judging by current gender proportions about half of this population will be women.

Slide 42: 

The question then is how will this increasing age group be looked after. With the breakdown of traditional social structures, it is even more vital that the government recognises and implements its role as care givers for menopausal women. At least 20 million women in developed countries are estimated to be currently using hormone replacement therapy (HRT). The average life expectancy for women in developed countries is around 75 years; approximately 90% of women reach the age of 65 years, and 30% reach 80 years. If the average age of menopause is 50 years, most women will spend approximately one third of their lifetime in postmenopausal life; one in every two women will experience about 30 years of postmenopausal life.