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Contraindications For Hormone Replacement Therapy

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Formulations And Route Of Menopause Ht

Hormone Replacement Therapy (HRT) for Medical Students

Various formulations and routes are available to allow for an individualized approach to menopause care including estrogens, progestogens, and tissue selective estrogen complex . Table 1 summarizes indications and contraindications for different formulations of HT.

Table 1 Indications and contraindications for menopausal hormone therapy .

Society And Public Perception

Wyeth, now a subsidiary of Pfizer, was a pharmaceutical company that marketed the HRT products Premarin and Prempro . In 2009, litigation involving Wyeth resulted in the release of 1,500 documents that revealed practices concerning its promotion of these medications. The documents showed that Wyeth commissioned dozens of ghostwrittenreviews and commentaries that were published in medical journals to promote unproven benefits of its HRT products, downplay their harms and risks, and cast competing therapies in a negative light. Starting in the mid-1990s and continuing for over a decade, Wyeth pursued an aggressive “publication plan” strategy to promote its HRT products through the use of ghostwritten publications. It worked mainly with DesignWrite, a medical writing firm. Between 1998 and 2005, Wyeth had 26 papers promoting its HRT products published in scientific journals.

Do Local Formulations Of Menopausal Hormone Therapy Have Different Risks

Both systemic and local treatment options for MHT are available in the United States. Which option a woman receives depends on the menopausal symptoms the treatment is meant to address. Systemic MHT is usually prescribed to treat hot flashes and to prevent osteoporosis. Systemic MHT with combined estrogen plus progestin or with estrogen alone can be given as oral medications as transdermal patches, gels, or sprays and as implants.

Local MHT is prescribed to treat genitourinary symptoms such as vaginal dryness. Local MHT contains low-dose estrogen only and is prescribed to women regardless of their hysterectomy status. Local MHT with low-dose estrogen alone includes creams, tablets , and rings.

Findings from the Womens Health Initiative Observational Study showed that, among women with an intact uterus, those who used vaginal estrogen and those who didnt had similar risks of stroke, invasive breast cancer, colorectal cancer, endometrial cancer, and pulmonaryembolism/deep vein thrombosis .

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Enhancing Healthcare Team Outcomes

Patients undergoing menopause require management from an interprofessional team that also includes the pharmacist and nurse. To improve patient outcomes, clinicians should not empirically prescribe hormone replacement therapy. These hormones correlate with a variety of adverse effects, including an increased risk of breast cancer, stroke, heart disease, and deep vein thrombosis. The duration of treatment of these hormones should not be more than a few years, and close monitoring is required. If the female has mild symptoms of menopause, then education should be provided about the benefits and harm of these hormones. The pharmacist should consult with the prescriber on the exact agent and dosing, while also examining the patient’s medication record. Nursing needs to be very aware of signs of adverse events, and monitor closely on subsequent visits, alerting the clinician of any concerns. This interprofessional team approach will drive the best outcomes with HRT.

Key Points: Cautions For Ht

ASK DIS: Pharmacy Drug Info (May
  • 1. For women with the uterus intact, estrogen must be administered together with progestogen to reduce the risk of endometrial hyperplasia and cancer.
  • 2. It is better to start MHT immediately once symptoms appear before or after menopause.
  • 3. There is no need to impose a limit on the duration of MHT as long as an effective minimum dose is used, if women are well aware of the potential benefits and risks, and a regular clinical follow-up observation is accompanied.
  • 4. Bioidentical MHT may be administered in excessive or very low doses, with no guidelines established for administration and routine tests, including blood tests.
  • 5. There is a lack of evidence of the effects and safety of complementary therapy.
  • 6. DHEA and ospemifene may be effective in treating GSM.

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Key Points: Venous Thromboembolism

  • 1. MHT increases the risk of venous thromboembolism. Particularly, the risk of VTE increases with age and increases in women initiating hormone therapy more than 10 years from menopausal onset.
  • 2. The risk of venous thromboembolism increases in the first 1 to 2 years of MHT and decreases afterwards.
  • 3. Estrogen therapy has a lower risk of venous thromboembolism than EPT, and if used in the early postmenopausal period, the risk of venous thromboembolism does not increase.
  • 4. Oral estrogen therapy is banned for patients with anamnesis of venous thromboembolism, and they must use transdermal estrogen.
  • 5. The occurrence of venous thromboembolism in Asian women is very low, and there has been no report of factor V Leiden mutation in South Korea.

What Should I Know About Storage And Disposal Of This Medication

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from heat and moisture .

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA’s Safe Disposal of Medicines website for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location â one that is up and away and out of their sight and reach.

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Key Points: Vasomotor Symptoms And Quality Of Life

  • 1. Because VMS appear in relation to the reduction of estrogen levels in the central nervous system, MHT is the most effective treatment.
  • 2. VMS are the main indications of MHT.
  • 3. Apart from VMS, MHT can treat other menopause symptoms such as sleep disorder, depression, and musculoskeletal pain and enhance the overall QoL of women in menopause.
  • 4. MHT is not associated with increased weight conversely, it helps improve the accumulation of abdominal fat.
  • 5. There is a tendency for symptoms to recur when therapy is discontinued.

Key Points: Coronary Artery Disease

How Hormone Replacement Therapy Saves Relationships
  • 1. In women aged less than 60 years and/or within 10 years of menopause with no evidence of cardiovascular disease, the initiation of hormone therapy could be expected to reduce the incidence of coronary heart disease and all-cause mortality.
  • 2. The effect of hormone therapy on coronary heart disease may differ depending on the use of progestogen and the timing of initiation.
  • 3. Currently, it is not recommended to initiate MHT solely for primary or secondary prevention of coronary heart disease.

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Tissue Selective Estrogen Complex

TSECs pairs a selective estrogen-receptor modulator with estrogen. The FDA approved medication marketed as DuaVee combines 20 mg bazedoxifene, a selective estrogen-receptor modulator, with 0.45 mg oCEE for use in postmenopausal women with a uterus. It is used for moderate to severe VMS and for prevention of osteoporosis. Compared to placebo, TSEC had a similar profile in that it did not increase breast tenderness, breast density, or endometrial thickness avoiding these conditions may be indications to use this therapy over other formulations. Amenorrhea occurs in more than 83% of users . It has not been studied regarding its ability to provide breast cancer risk reduction.

Added Benefits Of Hrt

HRT reduces the risk of various chronic conditions that can affect postmenopausal women, including:

  • diabetes taking HRT around the time of menopause reduces a womans risk of developing diabetes
  • osteoporosis HRT prevents further bone density loss, preserving bone integrity and reducing the risk of fractures, but it is not usually recommended as the first choice of treatment for osteoporosis, except in younger postmenopausal women
  • bowel cancer HRT slightly reduces the risk of colorectal cancer
  • cardiovascular disease HRT has been shown to reduce cardiovascular disease markers when used around the time of menopause.

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What Is Hormone Replacement Therapy

Overview

Hormone replacement therapy also referred to as menopausal hormone treatment or postmenopausal hormone therapy, is a type of hormone therapy used to ease the symptoms related to female menopause. Hot flashes, vaginal shrinkage, rapid skin ageing, vaginal dryness, reduced muscle mass, sexual dysfunction, and bone loss are some of the symptoms. They are mainly driven by decreased sex hormone levels that develop with menopause.

Estrogens and progestogens are the most common hormonal drugs used in Hormone replacement therapy for menopausal symptoms, with progesterone being the most common naturally occurring female sex hormone as well as a synthetic medication used in menopausal hormone treatment. Though both types of hormones can help with symptoms, when the uterus is present, a progestogen is added to oestrogen regimens to reduce the risk of endometrial cancer. This is because uncontrolled oestrogen treatment increases endometrial thickness, which raises the risk of cancer, whereas progestogen lowers the risk. Testosterone and other androgens are sometimes employed. HRT is available in several various forms.

What Should Women Do If They Have Menopausal Symptoms But Are Concerned About Taking Mht

The menopause

Women who are seeking relief from hot flashes and vaginal dryness should talk with their health care provider about whether to take MHT, the possible risks of using MHT, and what alternatives may be appropriate for them. FDA currently advises women to use MHT for the shortest time and at the lowest dose possible to control menopausal symptoms. The FDA provides additional information about the risks and benefits of MHT use for menopausal symptoms on its Menopause & Hormones: Common Questions fact sheet.

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Evaluation For Hormone Therapy

All candidates for HT should be thoroughly evaluated with a detailed history and complete physical examination for a proper diagnosis and identification of any contraindications.

Baseline laboratory and imaging studies before administering HT include the following:

  • Fasting lipid profile

  • Blood sugar levels

  • Serum estradiol levels: In women who will be prescribed an implant and in those whose symptoms persist despite use of an adequate dose of a patch or gel

  • Serum follicle-stimulating hormone levels: To monitor women taking oral preparations for symptomatic control, especially those with premature menopause

  • Ultrasonography: To measure endometrial thickness and ovarian volume

  • Electrocardiography

  • Papanicolaou test

  • Mammography: Performed once every 2-3 years and annually after the age of 50 years

Endometrial sampling is not required in routine practice. However, the presence of abnormal bleeding before or during HT should prompt consideration of ultrasonography to check endometrial thickness , followed by outpatient Pipelle sampling and hysteroscopy. In women with a tight cervix, formal hysteroscopy and dilation and curettage under general anesthesia are advised.

Gallbladder Disease And Migraine

Gallstone occurs in 10%â15% cases in the US and increases by 1 million people annually. The occurrence of gallbladder disease has a close association with estrogen therapy. In South Korea, the frequency of gallstones is about 2%â4% and the number of patients with gallstones has increased by 49% from 129,226 people in 2014 to 192,551 in 2018, according to the data from the Health Insurance Review and Assessment Service. This is because of the westernization of eating habits. Gallstones are more common among women than among men. In South Korea, it is reported to occur 1.1 times more frequently in women than in men, and the frequency increases in both genders from 40 to 50 years of age .

There is a lack of data on the relationship between MHT and migraine, and evidence for banning the use of MHT merely due to migraines is very rare.

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By Step Approach To Determine The Safety Of Prescribing Hormone Replacement Therapy

Dr. Roberto Leon MD FRCSC

Disclosures: Received an honorarium from Bayer for speaking at CME events on IUDs, and from Allergan for speaking on Lolo and Fibristal. Advisor for Pfizer for Duavive. No direct reference is made to products made by Bayer or Allergan in this article. No conflict of interest. Mitigating potential bias: Recommendations are consistent with published guidelines , International Menopause Society)

What I did before

One of the most complex decisions that women occasionally need to take in mid-life is whether to use prescription medications for their menopausal symptoms. Previously known as Hormone Replacement Therapy , Menopause Hormone Therapy is an effective and evidence based treatment for moderate to severe hot flashes and/or night sweats .

But women fear getting cancer, especially breast, or a heart attack. And certainly, there are risks associated with the consumption of hormones. As a gynecologist, identifying which patients are at a higher risk of complications has always been a challenge for me. Often it was an educated guess. In most women, however, the benefits outweigh the risks.

There are many great guidelines produced by reputable international organizations such as the Society of Obstetricians and Gynecologists of Canada , the North American Menopause Society , and the International Menopause Society , to name a few, but they all contain a large amount of scientific information but with very little practical guidance for everyday use.

Risks Benefits And Treatment Modalities Of Menopausal Hormone Therapy: Current Concepts

Hormone Replacement Therapy (HRT)
  • 1Department of Internal Medicine, Mayo Clinic, Phoenix, AZ, United States
  • 2Division of Womens Health Internal Medicine, Mayo Clinic, Scottsdale, AZ, United States
  • 3Department of Medicine, Brigham and Womens Hospital and Harvard Medical School, Boston, MA, United States

Menopausal hormone therapy prescribing practices have evolved over the last few decades guided by the changing understanding of the treatments risks and benefits. Since the Womens Health Initiative trial results in 2002, including post-intervention analysis and cumulative 18-year follow up, it has become clear that the risks of HT are low for healthy women less than age 60 or within ten years from menopause. For those who are experiencing bothersome vasomotor symptoms, the benefits are likely to outweigh the risks in view of HTs efficacy for symptom management. HT also has a role in preventing osteoporosis in appropriate candidates for treatment. A comprehensive overview of the types, routes, and formulations of currently available HT, as well as HTs benefits and risks by outcomes of interest are provided to facilitate clinical decision making.

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Breast Cancer And Hrt

Women over 50 years of age who use combined oestrogen and progestogen replacement for less than five years have little or no increased risk of breast cancer. Women who use combined HRT for more than five years have a slightly increased risk. Women on oestrogen alone have no increased risk up to 15 years of usage.

There is no evidence to suggest that a woman with a family history of breast cancer will have an added increased risk of developing breast cancer if she uses HRT. The risk with combined oestrogen and progestogen is greater than with oestrogen alone, or with newer HRT agents such as tibolone , and may also depend on the type of progestogen used. Studies suggest that medroxyprogesterone acetate and norethisterone have higher risks than dydrogesterone and progesterone.

Contraindications Of Hormone Replacement Therapy

ByMichael Russell | Submitted On November 24, 2006

Modern-day natural hormone replacement therapy is very flexible and safe and only a minority of menopausal women is told by their doctors that they should avoid it. However, if you suffer from, or have a history of cancer and severe liver disease, you will probably be advised never to take estrogen.

Severe liver disease, such as cirrhosis may also be a contraindication for hormone replacement therapy. Severe liver disease makes it difficult for your liver to break down or metabolize estrogen. Normal doses of estrogen replacement usually overtax a diseased liver so that liver function may worsen. Mild to moderate liver disease is not necessarily a contraindication to estrogen replacement, although in such a case it is wise you use only estrogen patches or vaginal estrogen, as these are most unlikely to overwork your liver. It is best to avoid oral estrogens in all cases of liver disease. If you have liver disease, you will need to consult your gastroenterologist about the type of liver disease you have. A blood test may be used to confirm the presence of a liver disease.

Michael Russell Your Independent guide to Menopause

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Hrt For Breast Cancer Survivors

It is advisable for women with a history of breast cancer to avoid HRT unless other treatments are ineffective, and their quality of life is made intolerable by menopausal symptoms. In these circumstances, HRT should only be prescribed in consultation with the womans breast surgeon or oncologist.

Evidence has not conclusively shown that HRT will increase the risk of breast cancer recurring in a woman with a history of the disease. However, oestrogen and progestogens may stimulate some types of cells in the breast and some types of HRT use have been associated with an increase in the risk of breast cancer in women without a history of breast cancer.

Cardiovascular Disease And Hrt

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Women over 60 have a small increased risk of developing heart disease or stroke on combined oral HRT. Although the increase in risk is small, it needs to be considered when starting HRT, as the risk occurs early in treatment and persists with time.

Oestrogen used on its own increases the risk of stroke further if taken in tablet form, but not if using a skin patch. Similarly, tibolone increases the risk of stroke in women from their mid-60s.

Women who commence HRT around the typical time of menopause have lower risks of cardiovascular disease than women aged 60 or more.

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