2013 IMS recommendations on menopausal hormone therapy and preventive strategies for midlife health – what ’ s new? Dobar Dan, Kako Ste? Nick Panay Immediate Past Chairman, British Menopause Society Co-Editor in Chief, Climacteric. www.imsociety.org. Brijuni 2013 Memories!.
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2013 IMSrecommendations on menopausal hormone therapy and preventive strategies for midlife health – what’s new?Dobar Dan, Kako Ste?Nick PanayImmediate Past Chairman, British Menopause SocietyCo-Editor in Chief, Climacteric
The International Menopause Society took the initiative to arrange a round table discussion between representatives of the major regional menopause societies to agree on core recommendations regarding MHT
It is acknowledged that in view of the global variance of disease and regulatory restrictions, these core recommendations should be read in the context of the more detailed recommendations prepared by the national and regional societies
Future data may come from patient registries and prospective observation of practice rather than RCTs
Regimens with transdermal estradiol and natural progesterone should be studied in younger cohorts to confirm efficacy and safety outcomes such as breast cancer
Journals should standardise they way in which data on HRT are presented to facilitate uniform reporting and interpretation of data by the media and public.
The WHI resulted in a significant decline in prescribing of Hormone Therapy
Cardiovascular outcomes have not changed based on limited data – however, changes may be seen in the next 5-10 years
Breast Cancer Incidence in the United States fell post WHI but had started to fall prior to initial reporting
Hip Fracture Risk increased after Hormone Therapy was stopped
Other outcomes e.g. mortality rates may become evident as time goes by……
Estrogen-only therapy in women aged 50 to 59 declined nearly 79 percent between 2001 and 2011
Minimum 18,601 – maximum 91,610 (probably around 50,000) excess deaths can be attributed to estrogen avoidance!
Sarrel PM, Njike VY, Vinante V, Katz DL. The Mortality Toll of Estrogen Avoidance: An Analysis of Excess Deaths Among Hysterectomized Women Aged 50 to 59 Years. Am J Public Health. 2013; 103(9): 1583-1588.
Any criticism of the media should be positive; the message is often complex – tell them what is important!
There is a “media culture”. Bad news make headlines, but they have a responsibility to keep things in context
Breast Cancer is the main issue because women fear this the most.
Need to make journalists and public realise that WHI opinion has moved on
Put benefits and risks into context – absolute rather than relative risk
The option of MHT is an individual decision in terms of quality of life and health priorities as well as personal risk factors such as age, time since menopause and the risk of thrombo-embolism, stroke, ischemic heart disease and breast cancer
The dose and duration of MHT should be consistent with treatment goals and should be individualized
MHT is the most effective treatment for moderate to severe menopausal symptoms before the age of 60 years or within 10 years after menopause
Local low dose estrogen therapy is preferred for women whose symptoms are limited to vaginal dryness or associated discomfort with intercourse.
Estrogen as a single systemic agent is appropriate in women after hysterectomy but additional progestogen is required in the presence of a uterus
The use of custom compounded bio-identical hormone therapy is not recommended
MHT is an effective treatment for the prevention of fracture in at risk women before age 60 years or within 10 years after menopause
Tobie De Villiers
Randomised clinical trials (RCT) and observational data as well as meta-analyses have provided strong evidence that standard dose estrogen alone MHT decreases coronary disease and all cause mortality in women younger than 60 years of age and within 10 years of menopause.
Data on estrogen plus progestogen in this population show a similar trend but with less precision.
MHT does not cause an increase in coronary events in healthy women less than 60 years of age or within 10 years of menopause.
Roger Lobo Key Data: KEEPS 2012 NAMS & DOPS 2012 BMJ
The risk of venous thromboembolism (VTE) and ischemic stroke increases with oral MHT but the absolute risk is rare below age 60 years.
Observational studies point to a lower risk with transdermal therapy.
Genevieve Plu Bureau
The risk of breast cancer in women over 50 years associated with MHT is a complex issue
The increased risk of breast cancer is primarily associated with the addition of a progestogen to estrogen therapy and related to the duration of use
The risk of breast cancer attributable to MHT is small and the risk decreases after treatment is stopped.
There is a lack of safety data supporting the use of MHT (estrogen therapy(ET) or estrogen progestogen therapy (EPT)) in breast cancer survivors.
In women with premature ovarian insufficiency, systemic MHT is recommended until the average age of the natural menopause.
The primary indication for testosterone is for the treatment of desire/arousal disorder
Several large placebo-controlled RCTs have consistently show benefits of testosterone for for sexual satisfaction, desire, arousal, pleasure and orgasm in..
…surgical, natural menopause, no HT and in pre menopause
Other potential benefits of testosterone therapy which require confirmation in large RCTs, include prevention of bone loss, maintenance of muscle mass and strength, maintenance of cognitive performance and favourable cardiovascular effects.
Androgenic side effects with testosterone therapy are dose related and avoidable.
There is no evidence from large placebo controlled RCTs that transdermal testosterone in appropriate doses for women results in adverse metabolic or endometrial effects
For midlife women, observational evidence indicates no persisting effects of the natural menopause on memory or other cognitive functions.
During the menopausal transition, some women experience transient problems.
The long-term cognitive consequences of HRT initiated during the menopausal transition or early postmenopause are unknown. There remains an urgent need for further research in this area.
For healthy postmenopausal women, there is clinical trial evidence that isoflavone supplements in a daily dose comparable to that consumed in traditional Asian diets has no overall effect on cognition.
1)Health Departments & Regulators – Encourage change of policy
2)The Prescribers – Expand education and training in menopause
3)Media – Engage positively highlighting favourable data
4)Pharma Industry – Reverse negative commercial/R&D decisions
5)The Menopausal Woman – Improve her access to information
6) HRT – Clarification of differences in action/risk profile
Six Action Points to Maximise Impact of Recommendations