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Million Women Study
Natural HRT
Livial HRT

 

 

Key areas

bulletCSM update November 2004.
bulletCSM advice after Million Women Study
bulletUS guidelines regarding chronic conditions published after WHI study

CSM update November 2004

Review of the evidence on long-term safety of HRT: Page 4 http://medicines.mhra.gov.uk/ourwork/monitorsafequalmed/currentproblems/currentproblems_oct04.pdf

HRT advice for prescribers in above document

bulletFor the treatment of menopausal symptoms the benefits of short-term HRT are considered to outweigh the risks in the majority of women.
bulletEach decision to start HRT should be made on an individual basis with a fully informed woman.
bulletIn all cases, it is good practice to use the lowest effective dose for the shortest possible time and to review the need to continue treatment at least annually. This review should take into account new knowledge and any changes in a woman’s risk factors and personal preferences.
bulletFor postmenopausal women who are at an increased risk of fracture and are aged over 50 years, HRT should be used to prevent osteoporosis only in those who are intolerant of, or contraindicated for, other osteoporosis therapies.
bulletWomen who are receiving HRT for their menopausal symptoms will benefit from the effect of HRT on osteoporosis prevention whilst on treatment.
bulletHealthy women who have no menopausal symptoms should be advised against taking HRT as the risks outweigh the benefits.
bulletHRT does not prevent coronary heart disease or a decline in cognitive function and should not be prescribed for these purposes.
bulletHRT remains contraindicated in women who have had breast cancer.
bulletFor women without a uterus, oestrogen-only therapy is appropriate.
bulletFor women with a uterus, oestrogen plus progestogen is recommended. However, women should be fully informed of the added risk of breast cancer and be involved in the decision-making process.

CSM advice issued after Million Women Study

The Committee on Safety of Medicines (CSM) has provided us with some information regarding the Million Women Study published in the Lancet on 8th August 2003.

The study looked at the effect of different types of hormone replacement therapy (HRT) on the risk of breast cancer in nearly a million postmenopausal women in the UK.

Compared to women not using HRT, use of oestrogen only HRT is associated with an extra 1 or 2 cases per 1000 women after 5 years use and an extra 5 cases per 1000 after 10 years use.

Compared to women not using HRT, use of combined oestrogen/progestogen  HRT is associated with an extra 6 cases per 1000 women after 5 years use and an extra 19 cases per 1000 after 10 years use.

Livial® tibolone (a steroid with combined oestrogenic, progestogenic and androgenic activity) also increases the risk of breast cancer but not as high as combined HRT.

The risk of breast cancer becomes apparent within 1-2 years of starting treatment irrespective of the type of HRT. The risk begins to decline when HRT is stopped and [surprisingly] by 5 years reaches the same level as in women who have never had HRT.

The CSM advises that

bulletFor short term use of HRT for relief of menopausal symptoms, benefits outweigh risks for many women
bulletFor longer term use, women must be made aware of the increased risk of breast cancer and other adverse effects
bulletEach decision about HRT is individual and treatment should be regularly appraised (at least once per year)
bulletFor combined HRT, the benefits of lower risk of endometrial disorders [including cancer] should be weighed against the increased risk of breast cancer. The risk of endometrial cancer with tibolone is not known
bulletThere is no necessity for urgent changes in treatment. Women wishing to stop or change treatment should make a routine appointment with their doctor
bulletAll women should be "breast aware" www.cancerscreening.nhs.uk/breastscreen/breastawareness.html

US guidelines for postmenopausal HRT 2002

Postmenopausal Hormone Replacement Therapy for Primary Prevention of Chronic Conditions: Recommendations and Rationale published by U.S. Preventive Services Task Force*
Summary for patients http://www.annals.org/issues/v137n10/fpdf/200211190-00004.pdf
Full details http://www.annals.org/issues/v137n10/pdf/200211190-00013.pdf

Oestrogen only HRT

Title WHI oestrogen only HRT study stopped due to increased risk of stroke
Date Published 03/03/2004. Author: Claudette Allerdyce

Abstract The National Institutes of Health (NIH) has announced that it has stopped its trial investigating the effect of oestrogen-only hormone replacement therapy (HRT) in 11,000 women, due to the increased risk of stroke in women using the drug.

The trial, which was part of the Women’s Health Initiative study, was designed to examine the effect of oestrogen-only HRT and included over 11,000 women, who were taking 0.625mcg of conjugated oestrogen (Premarin) once daily.

The NIH found that after an average follow-up period of 7-years, use of oestrogen only HRT has no effect on heart disease, however preliminary analysis of the results revealed that its use was associated with an increased risk of stroke that equates to an extra 8 strokes a year per 10,000 women (an increase from 21 to 29).

Other preliminary findings from the study are that oestrogen therapy:
• Decreased the risk of hip fracture;
• Did not increase the risk of breast cancer;
• Did not increase or decrease the overall risk or benefit of coronary heart disease (CHD);
• Increased the risk of stroke, similar to the increase in risk previously reported from the oestrogen plus progestin (E+P) study arm of WHI.

Postmenopausal oestrogen does not improve cognitive function

Question Does postmenopausal oestrogen therapy improve global cognitive function?
BMJ  2004;329 (4 September), doi:10.1136/bmj.329.7465.0-f

Synopsis The women's health initiative memory study previously reported that combined hormone replacement therapy (HRT) with oestrogen and progesterone does not improve global cognitive function in postmenopausal women. To determine the effect of HRT using oestrogen alone, 2947 women aged 65 to 79 years who had had a hysterectomy were randomised in double blind fashion to receive 0.625 mg per day of conjugated equine oestrogen or matching placebo. Individuals assessing outcomes were blinded to treatment group assignment. Follow up was complete for more than 95% of the study participants for a mean of 5.4 years. On intention to treat analysis, mean mini-mental state examination scores were 0.26 units lower in the treated group than in the placebo group (P = 0.04). The adverse effect of oestrogen was more pronounced in women with a lower cognitive function score at baseline.

Bottom line Postmenopausal oestrogen therapy does not improve—and may worsen—global cognitive function. Adverse effects may be more pronounced in women with pre-existing reduced cognitive function.

Espeland MA, Rapp SR, Shumaker SA, et al. Conjugated equine estrogens and global cognitive function in postmenopausal women. Women's Health Initiative Memory Study. JAMA 2004;291: 2959-68[Abstract/Free Full Text].

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